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\"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}, \"content\": [{\"text\": \"Pesée à partir de deux lots de titres respectifs T1 et T2 / weighing from 2 different batches with assay T1 and T2\", \"type\": \"text\"}]}]}]}, {\"type\": \"tableRow\", \"content\": [{\"type\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}, \"content\": [{\"text\": \"Q=Qn*(100/T) avec : Q : Quantité de matière à peser./ Quantity of material to be weighed Qn : Quantité theorique /theoritical quantity T : titre du produit ./assay Calcul/calculation :\", \"type\": \"text\"}]}]}, {\"type\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}, \"content\": [{\"text\": \"Soit Q1 la quantité de matière qui reste du lot N°1 de titre T1/ Q1 the quantity of material that remains from batch N ° 1 with assay T1 Soit Q2 la quantité de matière qui doit être pesée du lot numéro 2 de titre T2 The quantity Q2 of material that must be weighed from batch N ° 2 with assay T2 Q2=(100/T)*[(Qn-((Q1*T1)/100))] Lot N°1 T1 =\", \"type\": \"text\"}]}, {\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}, \"content\": [{\"text\": \"....................... 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\"paragraph\", \"attrs\": {\"textAlign\": \"left\"}, \"content\": [{\"text\": \"Vérifié par date et visa /checked by date and signature\", \"type\": \"text\"}]}]}]}, {\"type\": \"tableRow\", \"content\": [{\"type\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}}]}, {\"type\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}}]}]}]}, {\"type\": \"heading\", \"attrs\": {\"level\": 2, \"textAlign\": \"left\"}, \"content\": [{\"text\": \"28. 5. 2.\", \"type\": \"text\"}, {\"text\": \"Contrôle de l\'aspect/appearence control\", \"type\": \"text\", \"marks\": [{\"type\": \"textStyle\", \"attrs\": {\"color\": null, \"fontFamily\": null, \"data-section\": \"30.5.2\", \"data-question\": null}}]}]}, {\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}}, {\"type\": \"orderedList\", \"attrs\": {\"start\": 1}, \"content\": [{\"type\": \"listItem\", \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}, \"content\": [{\"text\": \"Prélever 10 comprimés et vérifier la conformité de l\'aspect et les dimensions au moyen du testeur de dureté. /take a sample of 10 tablet and check the appearance conformity and dimension with hardness tester\", \"type\": \"text\", \"marks\": [{\"type\": \"textStyle\", \"attrs\": {\"color\": null, \"fontFamily\": null, \"data-section\": null, \"data-question\": \"1\"}}]}]}, {\"type\": \"table\", \"attrs\": {\"data-question-id\": \"1091\", \"data-table-form-id\": \"1052\", \"data-table-form-status\": \"created\", \"data-header-orientation\": \"vertical\"}, \"content\": [{\"type\": \"tableRow\", \"content\": [{\"type\": \"tableHeader\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}, \"content\": [{\"text\": \"Norme\", \"type\": \"text\"}]}]}, {\"type\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}, \"content\": [{\"text\": \"Comprimé pelliculé jaune foncé, de forme ronde 6 mm, légèrement biconvexe/Dark yellow, round-shaped 6mm, slightly biconvex, film-coated tablet\", \"type\": \"text\"}]}]}]}, {\"type\": \"tableRow\", \"content\": [{\"type\": \"tableHeader\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}, \"content\": [{\"text\": \"Fait par date et visa /done by date and signature\", \"type\": \"text\"}]}]}, {\"type\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}}]}]}, {\"type\": \"tableRow\", \"content\": [{\"type\": \"tableHeader\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}, \"content\": [{\"text\": \"Vérifié par date et visa /checked by date and signature\", \"type\": \"text\"}]}]}, {\"type\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}}]}]}]}, {\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}, \"content\": [{\"text\": \"Vérifier l\'absence des défauts suivants\", \"type\": \"text\", \"marks\": [{\"type\": \"textStyle\", \"attrs\": {\"color\": null, \"fontFamily\": null, \"data-section\": null, \"data-question\": \"2\"}}]}]}, {\"type\": \"table\", \"attrs\": {\"data-question-id\": \"882\", \"data-table-form-id\": \"840\", \"data-table-form-status\": \"created\", \"data-header-orientation\": \"vertical\"}, \"content\": [{\"type\": \"tableRow\", \"content\": [{\"type\": \"tableHeader\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": [312]}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}, \"content\": [{\"text\": \"Absence d\'arrachement et de collage des comprimés/ Absence of tablet picking and sticking\", \"type\": \"text\"}]}]}, {\"type\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}, \"content\": [{\"text\": \"laissant des défauts à la surface de l\'enrobage ou des morceaux d\'enrobage enlevés/ leaving defects on the surface of the coating or pieces of coating removed\", \"type\": \"text\"}]}]}]}, {\"type\": \"tableRow\", \"content\": [{\"type\": \"tableHeader\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": [312]}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}, \"content\": [{\"text\": \"Absence de rugosité de surface/ Absence of surface roughness\", \"type\": \"text\"}]}]}, {\"type\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}, \"content\": [{\"text\": \"ressemblant souvent à de la peau d\'orange/ often resembling orange peel\", \"type\": \"text\"}]}]}]}, {\"type\": \"tableRow\", \"content\": [{\"type\": \"tableHeader\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": [312]}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}, \"content\": [{\"text\": \"Absence d\'érosion de la surface des comprimés\", \"type\": \"text\"}]}]}, {\"type\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}, \"content\": [{\"text\": \"Absence of tablet surface erosion\", \"type\": \"text\"}]}]}]}, {\"type\": \"tableRow\", \"content\": [{\"type\": \"tableHeader\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": [312]}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}, \"content\": [{\"text\": \"Absence de variabilité excessive des couleurs d\'une tablette à l\'autre\", \"type\": \"text\"}]}]}, {\"type\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}, \"content\": [{\"text\": \"Absence of excessive tablet- to-tablet color variability\", \"type\": \"text\"}]}]}]}]}, {\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}, \"content\": [{\"text\": \"Norme : Comprimé pelliculé jaune foncé, de forme ronde 6 mm, légèrement biconvexe/Dark yellow, round-shaped 6mm, slightly biconvex, film-coated tablet - Vérifier l\'absence des défauts suivants\", \"type\": \"text\"}]}]}]}, {\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}, \"content\": [{\"text\": \"/ Check the absence of the following defaults : Absence d\'arrachement et de collage des comprimés, laissant des défauts à la surface de l\'enrobage ou des morceaux d\'enrobage enlevés/ Absence of tablet picking and sticking, leaving defects on the surface of the coating or pieces of coating removed. Absence de rugosité de surface, ressemblant souvent à de la peau d\'orange/ Absence of surface roughness, often resembling orange peel. Absence d\'érosion de la surface des comprimés /Absence of tablet surface erosion. Absence de variabilité excessive des couleurs d\'une tablette à l\'autre /Absence of excessive tablet- to-tablet color variability.\", \"type\": \"text\"}]}, {\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}}, {\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}, \"content\": [{\"text\": \"Vérifier la conformité de l\'aspect et les dimensions des comprimés\", \"type\": \"text\", \"marks\": [{\"type\": \"textStyle\", \"attrs\": {\"color\": null, \"fontFamily\": null, \"data-section\": null, \"data-question\": \"3\"}}]}]}, {\"type\": \"table\", \"attrs\": {\"data-question-id\": \"883\", \"data-table-form-id\": \"841\", \"data-table-form-status\": \"created\", \"data-header-orientation\": \"horizontal\"}, \"content\": [{\"type\": \"tableRow\", \"content\": [{\"type\": \"tableHeader\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}, \"content\": [{\"text\": \"Contrôle aspect\", \"type\": \"text\"}]}, {\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}, \"content\": [{\"text\": \"/appearance control\", \"type\": \"text\"}]}]}, {\"type\": \"tableHeader\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}, \"content\": [{\"text\": \"T (min)\", \"type\": \"text\"}]}]}, {\"type\": \"tableHeader\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}, \"content\": [{\"text\": \"T (min)\", \"type\": \"text\"}]}]}, {\"type\": \"tableHeader\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}, \"content\": [{\"text\": \"T (min)\", \"type\": \"text\"}]}]}]}, {\"type\": \"tableRow\", \"content\": [{\"type\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}, \"content\": [{\"text\": \"Temps\", \"type\": \"text\"}]}]}, {\"type\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}}]}, {\"type\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}}]}, {\"type\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}}]}]}, {\"type\": \"tableRow\", \"content\": [{\"type\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}, \"content\": [{\"text\": \"Comp/ tablet 1\", \"type\": \"text\"}]}]}, {\"type\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}}]}, {\"type\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}}]}, {\"type\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}}]}]}, {\"type\": \"tableRow\", \"content\": [{\"type\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}, \"content\": [{\"text\": \"Comp/ tablet 2\", \"type\": \"text\"}]}]}, {\"type\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}}]}, {\"type\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}}]}, {\"type\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}}]}]}, {\"type\": \"tableRow\", \"content\": [{\"type\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}, \"content\": [{\"text\": \"Comp/ tablet 3\", \"type\": \"text\"}]}]}, {\"type\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}}]}, {\"type\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}}]}, {\"type\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}}]}]}, {\"type\": \"tableRow\", \"content\": [{\"type\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}, \"content\": [{\"text\": \"Comp/ tablet 4\", \"type\": \"text\"}]}]}, {\"type\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}}]}, {\"type\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}}]}, {\"type\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}}]}]}, {\"type\": \"tableRow\", \"content\": [{\"type\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}, \"content\": [{\"text\": \"Comp/ tablet 5\", \"type\": \"text\"}]}]}, {\"type\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}}]}, {\"type\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}}]}, {\"type\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}}]}]}, {\"type\": \"tableRow\", \"content\": [{\"type\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}, \"content\": [{\"text\": \"Comp/ tablet 6\", \"type\": \"text\"}]}]}, {\"type\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}}]}, {\"type\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}}]}, {\"type\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}}]}]}, {\"type\": \"tableRow\", \"content\": [{\"type\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}, \"content\": [{\"text\": \"Comp/ tablet 7\", \"type\": \"text\"}]}]}, {\"type\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}}]}, {\"type\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}}]}, {\"type\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}}]}]}, {\"type\": \"tableRow\", \"content\": [{\"type\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}, \"content\": [{\"text\": \"Comp/ tablet 8\", \"type\": \"text\"}]}]}, {\"type\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}}]}, {\"type\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}}]}, {\"type\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}}]}]}, {\"type\": \"tableRow\", \"content\": [{\"type\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}, \"content\": [{\"text\": \"Comp/ tablet 9\", \"type\": \"text\"}]}]}, {\"type\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}}]}, {\"type\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}}]}, {\"type\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}}]}]}, {\"type\": \"tableRow\", \"content\": [{\"type\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}, \"content\": [{\"text\": \"Comp/ tablet 10\", \"type\": \"text\"}]}]}, {\"type\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}}]}, {\"type\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}}]}, {\"type\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}}]}]}]}, {\"type\": \"orderedList\", \"attrs\": {\"start\": 2}, \"content\": [{\"type\": \"listItem\", \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}, \"content\": [{\"text\": \"A la fin du pelliculage Fermer le conteneur des comprimés et y apposer une étiquette de statut : Les comprimés sont stockés dans des récipients appropriés avec deux sacs en polyéthylène hermétiques identifiés avec étiquettes indiquant : nom du produit, numéro de lot, quantité et code.\", \"type\": \"text\", \"marks\": [{\"type\": \"textStyle\", \"attrs\": {\"color\": null, \"fontFamily\": null, \"data-section\": null, \"data-question\": \"4\"}}]}]}]}]}, {\"type\": \"table\", \"attrs\": {\"data-question-id\": \"885\", \"data-table-form-id\": \"842\", \"data-table-form-status\": \"created\", \"data-header-orientation\": \"horizontal\"}, \"content\": [{\"type\": \"tableRow\", \"content\": [{\"type\": \"tableHeader\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}, \"content\": [{\"text\": \"Fait par date et visa /done by date and signature\", \"type\": \"text\"}]}]}, {\"type\": \"tableHeader\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}, \"content\": [{\"text\": \"Vérifié par date et visa /checked by date and signature\", \"type\": \"text\"}]}]}]}, {\"type\": \"tableRow\", \"content\": [{\"type\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}}]}, {\"type\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}}]}]}]}, {\"type\": \"orderedList\", \"attrs\": {\"start\": 3}, \"content\": [{\"type\": \"listItem\", \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}, \"content\": [{\"text\": \"Procéder à la déconnexion de la T bin de chargement selon l\'instructionen vigueur Effectuer le cycle de nettoyage avant déconnexion\", \"type\": \"text\", \"marks\": [{\"type\": \"textStyle\", \"attrs\": {\"color\": null, \"fontFamily\": null, \"data-section\": null, \"data-question\": \"5\"}}]}]}]}]}, {\"type\": \"table\", \"attrs\": {\"data-question-id\": \"886\", \"data-table-form-id\": \"843\", \"data-table-form-status\": \"created\", \"data-header-orientation\": \"horizontal\"}, \"content\": [{\"type\": \"tableRow\", \"content\": [{\"type\": \"tableHeader\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}, \"content\": [{\"text\": \"Fait par date et visa /done by date and signature\", \"type\": \"text\"}]}]}, {\"type\": \"tableHeader\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}, \"content\": [{\"text\": \"Vérifié par date et visa /checked by date and signature\", \"type\": \"text\"}]}]}]}, {\"type\": \"tableRow\", \"content\": [{\"type\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": 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\"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}, \"content\": [{\"text\": \"Comprimés controle en cours : /IPC tablet\", \"type\": \"text\"}]}]}, {\"type\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}}]}]}, {\"type\": \"tableRow\", \"content\": [{\"type\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}}]}, {\"type\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}}]}, {\"type\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}}]}, {\"type\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}}]}]}, {\"type\": \"tableRow\", \"content\": [{\"type\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}}]}, {\"type\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}}]}, {\"type\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}, \"content\": [{\"text\": \"Comprimés rejetés par détecteur de métaux\", \"type\": \"text\"}]}, {\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}, \"content\": [{\"text\": \"/tablet rejected by metal detector\", \"type\": \"text\"}]}]}, {\"type\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}}]}]}, {\"type\": \"tableRow\", \"content\": [{\"type\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}}]}, {\"type\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}}]}, {\"type\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}}]}, {\"type\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}}]}]}]}, {\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}, \"content\": [{\"text\": \"Fait par / Vérifié par\", \"type\": \"text\", \"marks\": [{\"type\": \"textStyle\", \"attrs\": {\"color\": null, \"fontFamily\": null, \"data-section\": null, \"data-question\": \"5\"}}]}]}, {\"type\": \"table\", \"attrs\": {\"data-question-id\": \"424\", \"data-table-form-id\": \"398\", \"data-table-form-status\": \"created\", \"data-header-orientation\": \"horizontal\"}, \"content\": [{\"type\": \"tableRow\", \"content\": [{\"type\": \"tableHeader\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}, \"content\": [{\"text\": \"Fait par date et signature /done by date and signature\", \"type\": \"text\"}]}]}, {\"type\": \"tableHeader\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}, \"content\": [{\"text\": \"Vérifié par date et visa /checked by date and signature\", \"type\": \"text\"}]}]}]}, {\"type\": \"tableRow\", \"content\": [{\"type\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}}]}, {\"type\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}}]}]}]}, {\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}, \"content\": [{\"text\": \"Date et heure fin/ ending hour and date\", \"type\": \"text\"}]}, {\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}, \"content\": [{\"text\": \"Visa et date superviseur: signature and date supervisor\", \"type\": \"text\"}]}, {\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}}, {\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}, \"content\": [{\"text\": \"31.\", \"type\": \"text\", \"marks\": [{\"type\": \"bold\"}]}, {\"text\": \"DEVIATIONS, ET DECISON DU PCP/DEVIATION AND PRODUCTION DECISON\", \"type\": \"text\", \"marks\": [{\"type\": \"textStyle\", \"attrs\": {\"color\": null, \"fontFamily\": null, \"data-section\": \"31\", \"data-question\": null}}, {\"type\": \"bold\"}]}]}, {\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}}, {\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}, \"content\": [{\"text\": \"Déviation, et decision du pcp/deviation and production pharmacist decison\", \"type\": \"text\", \"marks\": [{\"type\": \"textStyle\", \"attrs\": {\"color\": null, \"fontFamily\": null, \"data-section\": null, \"data-question\": \"1\"}}]}]}, {\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}}, {\"type\": \"table\", \"attrs\": {\"data-question-id\": \"1095\", \"data-table-form-id\": \"1056\", \"data-table-form-status\": \"created\", \"data-header-orientation\": \"vertical\"}, \"content\": [{\"type\": \"tableRow\", \"content\": [{\"type\": \"tableHeader\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}}]}, {\"type\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}, \"content\": [{\"text\": \"Ce lot a été fabriqué selon le process approuvé et la documentation en vigueur. Tous les documents ont été vérifiés pour conformité. Les éventuelles déviations sont notées et commentées sur le formulaire ci haut. /This batch has been manufactured according to the approved process documentation. All documents have been verified for compliance. Any deviations are noted and commented on the\", \"type\": \"text\"}]}, {\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}, \"content\": [{\"text\": \"document above\", \"type\": \"text\"}]}]}]}, {\"type\": \"tableRow\", \"content\": [{\"type\": \"tableHeader\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}, \"content\": [{\"text\": \"N° déviation /deviation number\", \"type\": \"text\"}]}]}, {\"type\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}}]}]}, {\"type\": \"tableRow\", \"content\": [{\"type\": \"tableHeader\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}, \"content\": [{\"text\": \"Déviation /deviation\", \"type\": \"text\"}]}]}, {\"type\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}}]}]}, {\"type\": \"tableRow\", \"content\": [{\"type\": \"tableHeader\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}, \"content\": [{\"text\": \"Date et signature de l\'Ingénieur responsable production /production Engineer\", \"type\": \"text\"}]}]}, {\"type\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}}]}]}, {\"type\": \"tableRow\", \"content\": [{\"type\": \"tableHeader\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}, \"content\": [{\"text\": \"Date et signature du Pharmacien chargé des opérations de production /production pharmacist\", \"type\": \"text\"}]}]}, {\"type\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}}]}]}]}, {\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}}]}, \"content_format\": \"html_with_json\", \"conversion_date\": \"2025-10-06T13:32:16+00:00\"}','2025-10-06 12:32:16','2025-11-24 13:57:29');
INSERT INTO `documents` (`id`, `article_id`, `title`, `original_filename`, `file_hash`, `mime_type`, `file_size`, `html_content`, `metadata`, `created_at`, `updated_at`) VALUES (8,34,'Dossier_de_lot','Dossier_de_lot_Neapolis.docx','675361ab8348c048d90ed6b3a7e565347601e53d86926ba0b72b9b87e240df83','application/vnd.openxmlformats-officedocument.wordprocessingml.document',1696033,'<table style=\"min-width: 150px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"><strong>Rédaction/ redaction</strong></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"><strong>Vérification/verification</strong></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"><strong>Approbation/Approval</strong></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"><strong>Nom/name</strong></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Feriel MRABET</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Donia FOUDHAILI</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Salha GARBAYA</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Mahmoud ALSWISSI</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Mohamed Amine BOUJBEL</p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"><strong>Signature</strong></p><p style=\"text-align: left\"><strong>/Signature</strong></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"><strong>Date /date</strong></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><h1 style=\"text-align: left\">REGISTRE DE REVISION /MODIFICATION SUMMARY</h1><table style=\"min-width: 125px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"><strong>Numéro de l\'ancienne version</strong></p><p style=\"text-align: left\"><strong>/last version number</strong></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"><strong>Les modifications apportées sont/section modifiée (§)/modification description</strong></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"><strong>Date de modificati on/modific ation date</strong></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"><strong>Modifiée par</strong></p><p style=\"text-align: left\"><strong>/modified by</strong></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"><strong>Numéro de la nouvelle version/new version number</strong></p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">00</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Corriger la mention solution de pelliculage par suspension Ajout de la vérification de l\'intégrité des tamis après transfert Préciser que lors de l\'IPC de la compression et du pelliculage la vérification des dimensions du comprimé est effectuée au moyen du testeur de dureté Corriger la quantité de prélèvement pour Controle de l\'humidité résiduelle de 1.5 g à 5 g Modifier le nombre de comprimé pour test de dureté de 8 à 10 comprimés Ajouter la protection de la suspension de pelliculage après préparation et en cours de pelliculage Correct the mention coating solution by suspension Addition of sieve integrity check after transfer Specify that during the IPC of tabletting and film coating the verification of the dimensions of the tablet is carried out using the hardness tester Correct the amount of sample for Control of residual humidity from</p><p style=\"text-align: left\">1.5 g to 5 g Change the number of</p><p style=\"text-align: left\">tablets for hardness test from 8 to 10 tablets Add protection to the film coating suspension after preparation and during film coating</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">07/01/2020</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">PCP</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">01</p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">01</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Mise à jour selon les données de la validation /up date according the validation results CC19-13 Changement de la balance de reconciliation CC-20-27</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">16/09/2020</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">PCP</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">02</p></td></tr></tbody></table><table style=\"min-width: 150px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p><img class=\"editor-image\" src=\"media/image1.png\"></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"><strong>DOSSIER DE FABRICATION</strong></p><p style=\"text-align: left\"><strong>Manufacturing batch record</strong></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Page 3 / 112</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"><strong>DT-PN-0145</strong></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Version : 01</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">LETROZOLE NEAPOLIS 2.5 MG COMPRIME PELLICULE</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">NUMERO DE LOT</p><p style=\"text-align: left\">Batch number LETZ-5T030-205</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">02</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Ajout des paramètres de l\'environnement dans toutes les étapes du procédé de fabrication, ajout des holding time validés</p><p style=\"text-align: left\">/Addition of environmental parameters in all stages of the manufacturing process, addition of validated holding times</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">26/04/2021</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">PCP</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">03</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">03</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Mise à jour des paramètres selon la dernière version du rapport de validation Ajout partie récéption intrants, Préciser le type d\'alcool identification matières pesées, flux déchets, codes tamis, vérifcation intégrité tamis, Séparation de l\'opération vide de ligne de la partie paramètres environnement, Ajout code détecteur de métaux Ajout de la case observation, ajout des codes des instructions Correction de la désignation de distance buse pélliculage à angle rotation buse pelliculage Ajout de la liste des défauts pour contrôle en cours de pelliculage. Update of parameters according to the latest version of the validation report Addition of input reception part. Specify the type of alcool, identification of weighed materials, waste flows, sieve codes, sieve integrity verification, Separation of the empty line operation from the environment parameters part, Add metal detector code Addition of the observation box, addition of instruction codes Corrected lamination nozzle distance designation at lamination nozzle rotation angle Addition of the list of defects for control during filmcoating</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">29/03/2022</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">PCP</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">04</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">04</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Ajout du code de la cuve de préparation de la suspension de pelliculage CC 22-36 Addition of</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">27/02/2023</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">PCP</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">05</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><table style=\"min-width: 150px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p><img class=\"editor-image\" src=\"media/image1.png\"></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"><strong>DOSSIER DE FABRICATION</strong></p><p style=\"text-align: left\"><strong>Manufacturing batch record</strong></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Page 4 / 112</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"><strong>DT-PN-0145</strong></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Version : 01</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">LETROZOLE NEAPOLIS 2.5 MG COMPRIME PELLICULE</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">NUMERO DE LOT</p><p style=\"text-align: left\">Batch number LETZ-5T030-205</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">the preparation tank code change control 22-36</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">05</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Changement des paramétres selon la validation process Modification of parameters according to validation process</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">12/01/2024</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">PCP</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">06</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><p style=\"text-align: left\"><strong>SOMMAIRE / SUMMARY</strong></p><ol><li><p style=\"text-align: left\"><strong>PRÉSENTATION DU PRODUIT / PRODUCT PRESENTATION</strong></p></li><li><p style=\"text-align: left\"><strong>FORMULE DE FABRICATION / MANUFACTURING FORMULA</strong></p></li><li><p style=\"text-align: left\"><strong>PRECAUTIONS POUR LA FABRICATION /MANUFACTURING PRECAUTION</strong></p></li><li><p style=\"text-align: left\"><strong>FLOW CHART DE FABRICATION DU PRODUIT/PRODUCT MANUFACTURING FLOW CHART</strong></p></li><li><p style=\"text-align: left\"><strong>VERIFICATION ET RECEPTION DES INTRANTS /INPUT RECEPTION AND CHECK</strong></p></li><li><p style=\"text-align: left\"><strong>PESÉE DES EXCIPIENTS PHASE INTERNE /WEIGHING INTRA GRANULA EXCIPIENTS FRACTION 1</strong></p></li><li><p style=\"text-align: left\"><strong>PESÉE DE LA MATIERE ACTIVE PHASE INTERNE /WEIGHINGINTRA GRANULA : ACTIVE INGREDIENT FRACTION 1</strong></p></li><li><p style=\"text-align: left\"><strong>INCORPORATION DES COMPOSANTS DE LA PHASE INTERNE AU NIVEAU DE LA BIN</strong></p></li></ol><p style=\"text-align: left\"><strong>/INTRA GRANULA COUMPOUND TRANSFERT INTO THE BIN FRACTION 1</strong></p><ol start=\"9\"><li><p style=\"text-align: left\"><strong>PREPARATION DE LA SOLUTION DE GRANULATION /GRANULATION SOLUTION PREPARATION FRACTION 1</strong></p></li><li><p style=\"text-align: left\"><strong>MELANGE, GRANULATION, SECHAGE CALIBRAGE /DRY BLENDING, GRANULATION, DRYING MILLING FRACTION 1</strong></p></li><li><p style=\"text-align: left\"><strong>PESÉE DES EXCIPIENTS PHASE INTERNE /WEIGHING INTRA GRANULA EXCIPIENTS FRACTION 2</strong></p></li><li><p style=\"text-align: left\"><strong>PESÉE DE LA MATIERE ACTIVE PHASE INTERNE /WEIGHINGINTRA GRANULA : ACTIVE INGREDIENT FRACTION 2</strong></p></li><li><p style=\"text-align: left\"><strong>INCORPORATION DES COMPOSANTS DE LA PHASE INTERNE AU NIVEAU DE LA BIN</strong></p></li></ol><p style=\"text-align: left\"><strong>/INTRA GRANULA COUMPOUND TRANSFERT INTO THE BIN FRACTION 2</strong></p><ol start=\"14\"><li><p style=\"text-align: left\"><strong>PREPARATION DE LA SOLUTION DE GRANULATION /GRANULATION SOLUTION PREPARATION FRACTION 2</strong></p></li><li><p style=\"text-align: left\"><strong>MELANGE, GRANULATION, SECHAGE CALIBRAGE /DRY BLENDING, GRANULATION, DRYING MILLING FRACTION 2</strong></p></li><li><p style=\"text-align: left\"><strong>MELANGE ET HOMOGENISATION DES 2 FRACTIONS /GRANULATION FRACTIONS MIXING AND HOMOGENIZATION</strong></p></li><li><p style=\"text-align: left\"><strong>RECONCILIATION DE LA GRANULATION/GRANULATION YIELD CALCULATION</strong></p></li><li><p style=\"text-align: left\"><strong>PESEE DE LA PHASE EXTERNE / WEIGHING EXTRA GRANULA COMPOUND</strong></p></li><li><p style=\"text-align: left\"><strong>AJOUT DE LA PHASE EXTERNE PARTIE 1/EXTRA GRANULA COMPOUND INTEGRATION PART 1</strong></p></li><li><p style=\"text-align: left\"><strong>MELANGE PHASE EXTERNE PARTIE 1 /FINAL BLENDING PART 1</strong></p></li><li><p style=\"text-align: left\"><strong>AJOUT DE LA PHASE EXTERNE PARTIE 2/EXTRA GRANULA COMPOUND INTEGRATION PART 2</strong></p></li><li><p style=\"text-align: left\"><strong>MELANGE PHASE EXTERNE PARTIE 2 /FINAL BLENDING PART 2</strong></p></li><li><p style=\"text-align: left\"><strong>RECONCILIATION DU MELANGE FINAL /FINAL BLEND YIELD CALCULATION</strong></p></li><li><p style=\"text-align: left\"><strong>COMPRESSION /TABLETTING</strong></p></li><li><p style=\"text-align: left\"><strong>RECONCILIATION DE LA COMPRESSION /TABLETTING YIELD CALCULATION</strong></p></li><li><p style=\"text-align: left\"><strong>PESÉE DE L\'EXCIPIENT DE PELLICULAGE /WEIGHING FILM COATING EXCIPIENT</strong></p></li><li><p style=\"text-align: left\"><strong>PREPARATION DE LA SUSPENSION DE PELLICULAGE /COATING SUSPENSION PREPARATION</strong></p></li><li><p style=\"text-align: left\"><strong>PELLICULAGE /FILMCOATING</strong></p></li><li><p style=\"text-align: left\"><strong>RECONCILIATION DU PELLICULAGE / FILM COATING YIELD CALCULATION</strong></p></li><li><p style=\"text-align: left\"><strong>GESTION DES DECHETS/WASTE MANAGEMENT</strong></p></li></ol><h1 style=\"text-align: left\"><span data-section=\"1\">PRESENTATION DU PRODUIT : / PRODUCT PRESENTATION</span></h1><p style=\"text-align: left\"></p><p style=\"text-align: left\">               <span data-question=\"1\">PRESENTATION DU PRODUIT : / PRODUCT PRESENTATION</span></p><table data-table-form-id=\"6664\" data-question-id=\"8932\" data-header-orientation=\"horizontal\" data-table-form-status=\"created\" style=\"min-width: 50px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"><strong>Désignation / Designation</strong></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">LETROZOLE NEAPOLIS 2.5 MG COMPRIME PELLICULE</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"><strong>DCI / INN</strong></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">LETROZOLE</p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"><strong>Durée de vie / Shelf life</strong></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">24 MOIS / month</p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"><strong>Modèle / Model</strong></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">LOCAL/HOSPITALIER /local hospital</p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"><strong>Forme pharmaceutique</strong></p><p style=\"text-align: left\"><strong>/ Pharmaceutical form</strong></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Comprimé pelliculé rond biconvexe 6mm Film Coated round diameter 6mm biconvex tablet</p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"><strong>Dosage / Strength</strong></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">2.5 mg</p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"><strong>Taille de lot en kg / Batch size (kg)</strong></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">10 kg</p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"><strong>Taille de lot en UP / Batch size in unit</strong></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">100000 comprimés / tablets</p></td></tr></tbody></table><ol start=\"2\"><li><p style=\"text-align: left\"><span data-section=\"2\"><strong>FORMULE DE FABRICATION/MANUFACTURING FORMULA</strong></span></p><p style=\"text-align: left\"><span data-question=\"1\">FORMULE DE FABRICATION/MANUFACTURING FORMULA</span></p></li></ol><table data-table-form-id=\"6665\" data-question-id=\"8935\" data-header-orientation=\"horizontal\" data-table-form-status=\"created\" style=\"min-width: 100px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"><strong>Code article</strong></p><p style=\"text-align: left\"><strong>/ Item code</strong></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"><strong>Désignation / Designation</strong></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"><strong>Quantité unitaire</strong></p><p style=\"text-align: left\"><strong>/ Quantity unit</strong></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"><strong>Quantité par lot / Quantity per batch 10 kg =</strong></p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">MAN00007</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">LETROZOLE</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">2.5 mg</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">250 g</p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">MEN00001</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">LACTOZE MONOHYDRATE</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">50 mg</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">5000 g</p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">MEN00012</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">CELLULOSE MICROCRISTALLINE PH 101</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">28 mg</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">2800 g</p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">MEN00011</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">CROSPOVIDONE</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">4 mg</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">400 g</p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">MEN00020</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">STARCH 1500</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">11.5 mg</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">1150 g</p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">MEN00011</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">CROSPOVIDONE</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">4 mg</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">400 g</p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">MEN00010</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">SODUIM STARCH GLYCOLATE</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">2.5 mg</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">250 g</p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">MEN00021</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">COLLOIDAL SILICONE DIOXIDE AEROSIL 200</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">0.5 mg</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">50 g</p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">MEN00013</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">MAGNESUIM STEARATE</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">1 mg</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">100 g</p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">MEN00041</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">PURIFIED WATER</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Qs</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Qs 2.6 liter</p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">POIDS TOTAL COMPRIME NU / TOTAL UNCOATED TABLET WEIGHT</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">100 mg</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">10000 g</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">MEN00037</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">OPADRY II JAUNE/YELLOW</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">3 mg</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">600 g *</p></td></tr></tbody></table><table style=\"min-width: 125px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p><img class=\"editor-image\" src=\"media/image1.png\"></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"><strong>DOSSIER DE FABRICATION</strong></p><p style=\"text-align: left\"><strong>Manufacturing batch record</strong></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Page 9 / 112</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"><strong>DT-PN-0145</strong></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Version : 01</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">LETROZOLE NEAPOLIS 2.5 MG COMPRIME PELLICULE</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">NUMERO DE LOT</p><p style=\"text-align: left\">Batch number LETZ-5T030-205</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"><strong>Code article</strong></p><p style=\"text-align: left\"><strong>/ Item code</strong></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"><strong>Désignation / Designation</strong></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"><strong>Quantité unitaire</strong></p><p style=\"text-align: left\"><strong>/ Quantity unit</strong></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"><strong>Quantité par lot / Quantity per batch 10 kg =</strong></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">MEN00041</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">PURIFIED WATER</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Qs</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Qs 4 liters</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">POIDS TOTAL COMPRIME PELLICULE / TOTAL COATED TABLET WEIGHT</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">103 mg</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">10600 g</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><p style=\"text-align: left\"><strong>(*) Contient un excèdent de 100% pour compenser les pertes lors du pelliculage / contains an excess of 100% to compensate the loss during filmcoating</strong></p><p style=\"text-align: left\"><strong>Joindre le bon de sortie à cette page / Attach to this page the goods issue document</strong></p><ol start=\"3\"><li><p style=\"text-align: left\"></p></li></ol><h1 style=\"text-align: left\">PRECAUTIONS POUR LA FABRICATION /MANUFACTURING PRECAUTION</h1><ol><li><p style=\"text-align: left\">Précautions vis à vis du personnel( se référer à la fiche donnée sécurité des produits) /personnal precaution (refer to product safety data sheet)</p></li></ol><p style=\"text-align: left\">Toutes les opérations de fabrication: de la pesée au pelliculage doivent être réalisées à l\'int d\'un système fermé isolateur/all the operations from weighing to film coating must be done in closed system or under isolator Protection des mains/ hand protection: Porter des doubles gants/wear double gloves Protection des yeux : Porter des lunettes de sécurité ou un masque complet/eye protection:wear safety glass or full face protection mask En cas de déversement accidentel ou un risque de dégagement incontrôlé. appliquer vigueur/In case of accidental spill or risk of uncontrolled release apply the instruction . En cas de contact avec les yeux: Rincer immédiatement les yeux avec de l\'eau pendant au moins 15 min. Si une irritation se produit ou persiste, notifier votre superviseur hiérarchique/in case of eye contact immediately flush eyes with water for at least 15 min. If irritation occurs or persists, notify your supervisor En cas de contact avec la peau Laver la zone exposée avec du savon et de l\'eau et enlever les vêtements / chaussures contaminés, si une irritation se produit ou persiste, avertir le personnel médical et le superviseur/In case of skin contact Wash exposed area with soap and water and remove contaminated clothes/shoes, if irritation occurs or persists, notify medical personnel and supervisor En cas d\'inhalation Amener immédiatement le sujet exposé à l\'air frais. Sl ne respire pas, procéder à la respiration artificielle. Si la respiration est difficile, administrer de l\'oxygène. Aviser immédiatement le personnel médical et le superviseur/In case of inhalation Immediately move the exposed person to fresh air. If she is not breathing, give artificial respiration. If breathing is difficult, administer oxygen. Immediately notify the medical staff and supervisor. En cas d\'ingestion Ne pas faire vomir à moins d\'indication contraire du personnel médical, ne donner rien à boire à moins d\'avis contraire du personnel médical, avertir le personnel médical et le superviseur/If swallowed Do not induce vomiting unless directed to do so by medical personnel, give nothing to drink unless directed by medical personnel, notify medical personnel and supervisor</p><h1 style=\"text-align: left\"><span data-section=\"4\">FLOW CHART DE FABRICATION DU PRODUIT/PRODUCT MANUFACTURING FLOW CHART</span></h1><p style=\"text-align: left\"></p><img class=\"editor-image\" src=\"media/image2.png\"><p style=\"text-align: left\">FLOW CHART LETROZOLE NEAPOLIS 2.5 MG</p><h1 style=\"text-align: left\"><span data-section=\"5\">VERIFICATION ET RECEPTION DES INTRANTS /INPUT RECEPTION AND CHECK</span></h1><p style=\"text-align: left\">Date et heure début/date and hour of starting</p><ol><li><p style=\"text-align: left\"><span data-question=\"1\">Vérifier la disponibilité de la quantité correspondante à la taille de lot du / check the availability and correpondance quantity to batch size of : Letrozole code MAN00007</span></p></li></ol><table data-table-form-id=\"6677\" data-question-id=\"8956\" data-header-orientation=\"horizontal\" data-table-form-status=\"created\" style=\"min-width: 100px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Quantité/quanti ty</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Numéro de lot/batch number</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Date de pérem ption/expiry date</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Numéro de fraction/fraction number</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"2\"><li><p style=\"text-align: left\"><span data-question=\"2\">Vérifier la disponibilité de la quantité correspondante à la taille de lot du / check the availability and correpondance quantity to batch size of : Lactose monohydrate code MEN00001</span></p></li></ol><table data-table-form-id=\"6678\" data-question-id=\"8957\" data-header-orientation=\"horizontal\" data-table-form-status=\"created\" style=\"min-width: 100px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Quantité/quanti ty</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Numéro de lot/batch number</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Date de pérem ption/expiry date</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Numéro de fraction/fraction number</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"3\"><li><p style=\"text-align: left\">Vérifier la disponibilité de la quantité correspondante à la taille de lot du / check the availability and correpondance quantity to batch size of : cellulose microcristalline ph 101 code MEN00012</p></li><li><p style=\"text-align: left\">Vérifier la disponibilité de la quantité correspondante à la taille de lot du / check the availability and correpondance quantity to batch size of : crospovidone code MEN00011</p></li></ol><table style=\"min-width: 150px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Quantité/quanti ty</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Numéro de lot/batch number</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Date de pérem ption/expiry date</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Numéro de fraction/fraction number</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et signature /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa</p><p style=\"text-align: left\">/checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"5\"><li><p style=\"text-align: left\">Vérifier la disponibilité de la quantité correspondante à la taille de lot du / check the availability and correpondance quantity to batch size of : starch 1500 code MEN00020</p></li><li><p style=\"text-align: left\">Vérifier la disponibilité de la quantité correspondante à la taille de lot du / check the availability and correpondance quantity to batch size of : sodium starch glycolate code MEN00010</p></li></ol><table style=\"min-width: 150px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Quantité/quanti ty</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Numéro de lot/batch number</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Date de pérem ption/expiry date</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Numéro de fraction/fraction number</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et signature /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa</p><p style=\"text-align: left\">/checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"7\"><li><p style=\"text-align: left\">Vérifier la disponibilité de la quantité correspondante à la taille de lot du / check the availability and correpondance quantity to batch size of : colloidale silicone dioxide aerosil 200 code MEN00021</p></li></ol><table style=\"min-width: 150px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Quantité/quanti ty</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Numéro de lot/batch number</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Date de pérem ption/expiry date</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Numéro de fraction/fraction number</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et signature /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa</p><p style=\"text-align: left\">/checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"8\"><li><p style=\"text-align: left\">Vérifier la disponibilité de la quantité correspondante à la taille de lot du / check the availability and correpondance quantity to batch size of : magnesium stearate code MEN00013</p></li><li><p style=\"text-align: left\">Vérifier la disponibilité de la quantité correspondante à la taille de lot du / check the availability and correpondance quantity to batch size of : opadry 2 jaune /yellow code MEN00037</p></li></ol><table style=\"min-width: 150px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Quantité/quanti ty</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Numéro de lot/batch number</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Date de pérem ption/expiry date</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Numéro de fraction/fraction number</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et signature /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa</p><p style=\"text-align: left\">/checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><p style=\"text-align: left\">Observations</p><p style=\"text-align: left\">Date et heure fin/ ending hour and date</p><p style=\"text-align: left\">Visa et date superviseur: signature and date supervisor</p><h1 style=\"text-align: left\"><span data-section=\"6\">PESÉE DES EXCIPIENTS PHASE INTERNE /WEIGHING INTRA GRANULA EXCIPIENTS FRACTION 1</span></h1><p style=\"text-align: left\"><span data-question=\"1\">Equipement</span></p><table data-table-form-id=\"6666\" data-question-id=\"8936\" data-header-orientation=\"horizontal\" data-table-form-status=\"created\" style=\"min-width: 75px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Désignation équipement/equipment designation</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Code</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Dernière date de qualification/étalonnage last calibration and qualification date</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Centrale de pesée /weighing booth</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">EQ HP ECE 03</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Balance de pesée /weighing scale</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">EQHP DSM 01</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><p style=\"text-align: left\">Date et heure début/starting date and hour</p><ol><li><p style=\"text-align: left\"><span data-question=\"3\">Vérifier le vide de ligne et le nettoyage de la balance et de la centrale de pesée /check the line clearance and the cleaning of the weighing booth and scale</span></p></li><li><p style=\"text-align: left\"><span data-question=\"2\">Vérifier la conformité des paramètres de l\'environnement /check the conformity of environnement parameter</span></p></li></ol><table data-table-form-id=\"6667\" data-question-id=\"8937\" data-header-orientation=\"horizontal\" data-table-form-status=\"created\" style=\"min-width: 125px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Paramètre</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Norme</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Valeur lue/value</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa /checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Temperature</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">21±3°C</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Humidité /humidity</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">55±10%</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Pression</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">20±5 Pa</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"3\"><li><p style=\"text-align: left\">Indiquer le produit précédemment fabriqué ainsi que son n° de lot /indicate the previous product manufactured and the corresponding batch number</p></li></ol><table style=\"min-width: 100px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Désignation /designation</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Numéro de lot/batch number</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa</p><p style=\"text-align: left\">/done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa/checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"4\"><li><p style=\"text-align: left\">Vérifier la disponibilité et /ou le nettoyage des accessoires de pesée /check the availability and /or the cleaning of weighing tool</p></li><li><p style=\"text-align: left\">Vérifier l\'étalonnage de la balance/ check the scale calibration</p></li></ol><table style=\"min-width: 50px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa/checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"6\"><li><p style=\"text-align: left\">Coller une étiquette d\'identification code DT-PN-0252 sur les sacs pour chaque intrant à pesée / Stick an identification label code DT-PN-0252 on the bags for each input to be weighed</p></li></ol><table style=\"min-width: 50px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa/checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"7\"><li><p style=\"text-align: left\"><span data-question=\"5\">Effectuer les pesées selon l\'instruction en code DO-PN-100 /start the weighing according SOP code DO-PN-100 : La quantité de matière à peser est calculée selon l’équation suivante</span></p></li></ol><table style=\"min-width: 50px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Pesée à partir d’un seul lot de titre T/weighing from only one batch with assay: T</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Pesée à partir de deux lots de titres respectifs T1 et T2 / weighing from 2 different batches with assay T1 and T2</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Q=Qn*(100/T) avec : Q : Quantité de matière à peser./ Quantity of material to be weighed Qn : Quantité theorique /theoritical quantity T : titre du produit ./assay Calcul/calculation :</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Soit Q1 la quantité de matière qui reste du lot N°1 de titre T1/ Q1 the quantity of material that remains from batch N ° 1 with assay T1 Soit Q2 la quantité de matière qui doit être pesée du lot numéro 2 de titre T2 The quantity Q2 of material that must be weighed from batch N ° 2 with assay T2 Q2=(100/T2)*[(Qn-((Q1*T1)/100))] Lot N°1 T1 =</p><p style=\"text-align: left\">....................... Lot N°2 T2 = Q1 =</p><p style=\"text-align: left\">....................... Q2 = ......................</p></td></tr></tbody></table><ol start=\"8\"><li><p style=\"text-align: left\"><span data-question=\"4\">A la fin de la pesée effectuer un nettoyage de la centrale, de la balance et du local /at the end of weighing start the cleaning of dispensing booth , scale and room</span></p></li></ol><p style=\"text-align: left\">Observations</p><p style=\"text-align: left\">Date et heure fin ending date and hour</p><p style=\"text-align: left\">Visa et date superviseur/signature and date supervisor</p><p style=\"text-align: left\">Joindre le vide de ligne de l\'equipement/local et l\'étiquette statut local/attach the equipment/room line clearance label and cleaning label of room</p><h1 style=\"text-align: left\">PESÉE DE LA MATIERE ACTIVE PHASE INTERNE /WEIGHINGINTRA GRANULA : ACTIVE INGREDIENT FRACTION 1</h1><p style=\"text-align: left\">Equipement</p><table style=\"min-width: 75px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Désignation équipement/equipment designation</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Code</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Dernière date de qualification/étalonnage last calibration and qualification date</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><p style=\"text-align: left\">Date et heure début/starting date and hour</p><ol><li><p style=\"text-align: left\">Vérifier le vide de ligne et le nettoyage de la balance et de l’isolateur de pesée / check the line clearance of the weighing isolator and scale</p></li><li><p style=\"text-align: left\">Vérifier la conformité des paramètres de l\'environnement /check the conformity of environnement parameter</p></li></ol><table style=\"min-width: 125px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Norme</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Valeur lue/value</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa /checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Temperature</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">21±3°C</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Humidité /humidity</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">55±10%</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Pression</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">20±5 Pa</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"3\"><li><p style=\"text-align: left\">Indiquer le produit précédemment fabriqué ainsi que son n° de lot /indicate the previous product manufactured and the corresponding batch number</p></li></ol><table style=\"min-width: 125px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Désignation/design ation</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Numéro de lot/batch number</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Code Atelier</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"4\"><li><p style=\"text-align: left\">Vérifier la disponibilité et /ou le nettoyage des accessoires de pesée /check the availability and /or the cleaning of weighing tool</p></li><li><p style=\"text-align: left\">Vérifier l\'étalonnage de la balance / check the scale calibration</p></li></ol><table style=\"min-width: 50px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa/checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"6\"><li><p style=\"text-align: left\">Entamer le test d\'étanchéité automatique de l\'isolateur /start the isolator leak test</p></li></ol><table style=\"min-width: 100px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Test d\'étanchéité</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Résultat/result</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><p style=\"text-align: left\">Si non conforme refaire le test , si la non conformité persiste informer votre supérieur hiérarchique./ if the test is non-compliant repeat the test, if non conformity persists inform your supervisor</p><table style=\"min-width: 50px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Test non conforme</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Test conforme</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"7\"><li><p style=\"text-align: left\">Indiquer les paramètres suivants</p></li></ol><table style=\"min-width: 125px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Paramètre</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Consigne/set</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Valeur/value</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Pression Préchambre /pre chamber pressure</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">- 75PA</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Pression chambre principale / Main chamber pressure</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">-100PA</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"8\"><li><p style=\"text-align: left\">Coller une étiquette d\'identification code DT-PN-0252 sur les sacs pour chaque intrant à peser / Stick an identification label code DT-PN- 0252 on the bags for each input to be weighed</p></li></ol><table style=\"min-width: 50px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa/checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"9\"><li><p style=\"text-align: left\">Introduire respectivement au niveau de la première chambre de l\'isolateur les accessoires de pesée à usage unique , le conteneur de la matière première après essuyage à éthanol 70%, tissu de nettoyage, sac de pesée étiqueté /in the isolator prechamber , introduce the single use weighing accessories, the container of the raw material after wiping with ethanol 70%, cleaning wipes, labled weighing bag,</p></li><li><p style=\"text-align: left\">Ouvrir le conteneur de la matière première ; récupérer le sac interne , le poser sur le plateau ,enlever le 1er sac effectuer une désinfection de l\'autre sac et le faire entrer au niveau de la chambre de pesée./ Open the raw material container; retrieve the inner bag, place it on the platform, remove the 1st bag disinfect the other bag and bring it into the weighing chamber</p></li></ol><table style=\"min-width: 50px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa/checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"11\"><li><p style=\"text-align: left\">Effectuer la pesée selon l\'instruction code DO-PN-108 /carry out weighing according SOP code DO- PN-108: La quantité de matière à peser est calculée selon l\'équation suivante : /the quantity of material to weigh is calculated according the equation</p></li></ol><table style=\"min-width: 100px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p><img class=\"editor-image\" src=\"media/image1.png\"></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"><strong>DOSSIER DE FABRICATION</strong></p><p style=\"text-align: left\"><strong>Manufacturing batch record</strong></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Page 19 / 112</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"><strong>DT-PN-0145</strong></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Version : 01</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">LETROZOLE NEAPOLIS 2.5 MG COMPRIME PELLICULE</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">NUMERO DE LOT</p><p style=\"text-align: left\">Batch number LETZ-5T030-205</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Pesée à partir d’un seul lot de titre T/weighing from only one batch with assay: T</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Pesée à partir de deux lots de titres respectifs T1 et T2 / weighing from 2 different batches with assay T1 and T2</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Q=Qn*(100/T) avec : Q : Quantité de matière à peser./ Quantity of material to be weighed Qn : Quantité theorique /theoritical quantity T : titre du produit ./assay Calcul/calculation :</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Soit Q1 la quantité de matière qui reste du lot N°1 de titre T1/ Q1 the quantity of material that remains from batch N ° 1 with assay T1 Soit Q2 la quantité de matière qui doit être pesée du lot numéro 2 de titre T2 The quantity Q2 of material that must be weighed from batch N ° 2 with assay T2 Q2=(100/T2)*[(Qn-((Q1*T1)/100))] Lot N°1 T1 =</p><p style=\"text-align: left\">....................... Lot N°2 T2 = Q1 =</p><p style=\"text-align: left\">....................... Q2 = ......................</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"12\"><li><p style=\"text-align: left\">Fermer le sac de matière à retourner à l\'aide d\'un sert câble, essuyer la surface externe de ce dernier avec de l’éthanol 70% et le faire sortir à travers le liner</p></li></ol><table style=\"min-width: 50px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa/done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa/checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"13\"><li><p style=\"text-align: left\">A la fin récupérer les déchets et les accessoires de pesée à usage unique et le faire sortir à travers le liner /At the end collect the waste and single use weighing accessories and take them out through the liner</p></li></ol><table style=\"min-width: 50px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa/checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"14\"><li><p style=\"text-align: left\">Effectuer le nettoyage de l\'isolateur et la balanceselon l\'instruction en code DO-PN-0092 /clean the isolator and scale according to the SOP code DO-PN-0092</p></li></ol><p style=\"text-align: left\">Observations</p><table style=\"min-width: 75px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Observations</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa /checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><p style=\"text-align: left\">Date et heure fin/ending date and hour</p><p style=\"text-align: left\">Visa et date superviseur /signature and date supervisor</p><p style=\"text-align: left\">Joindre le vide de ligne de l’equipement et l’etiquette statut local/accessoire et équipement / attach the equipment line clearance label and cleaning label of room, accessories and equipements.</p><table style=\"min-width: 100px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p><img class=\"editor-image\" src=\"media/image1.png\"></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"><strong>DOSSIER DE FABRICATION</strong></p><p style=\"text-align: left\"><strong>Manufacturing batch record</strong></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Page 20 / 112</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"><strong>DT-PN-0145</strong></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Version : 01</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">LETROZOLE NEAPOLIS 2.5 MG COMPRIME PELLICULE</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">NUMERO DE LOT</p><p style=\"text-align: left\">Batch number LETZ-5T030-205</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><table style=\"min-width: 275px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">FICHE PESEE FRACTION 1/WEIGHING SHEET FRACTION 1</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Code/code</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Désignation/designation</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">N° de lot/batch number</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Titre/assay</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Quantité no menclature/t he theoretical</p><p style=\"text-align: left\">quantity</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Quantité à p eser/quantit y to weigh</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Quantité pes ée/quantity weighed</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Code balance/scal e code</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par/done by</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par/checked by</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">MAN00007</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Phase interne</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Letrozole</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">125 g</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">EQHPDSM02</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">MAN00007</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Letrozole *</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">125 g</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">EQHPDSM02</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">MAN00001</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Lactose monhydrate</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">F1 : 250 g (10%) F2 :</p><p style=\"text-align: left\">1125 g</p><p style=\"text-align: left\">(45%) F3 :</p><p style=\"text-align: left\">1125 g(45%)</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">EQHPDSM01</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">MEN00012</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Cellulose mi crocristalline</p><p style=\"text-align: left\">ph 101</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">1400 g</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">EQHPDSM01</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">MAN00010</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Sodium</p><p style=\"text-align: left\">starch glycolate</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">75 g (60%)</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">EQHPDSM01</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">MAN00011</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Crospovidon</p><p style=\"text-align: left\">e</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">200 g</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">EQHPDSM01</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">MAN00041</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Liant</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Purified</p><p style=\"text-align: left\">water</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">QS 1.3 kg</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">EQHPDSM06</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><p style=\"text-align: left\"><strong>*si la matière à disposition appartient à 2 lots de titres différents / if the raw material belongs to two different batches having two different assay</strong></p><p style=\"text-align: left\"><strong>nombre de contanants / number of container:</strong></p><p style=\"text-align: left\"><strong>Joindre les étiquettes de pesée à cette page / attach the weighing label to this page</strong></p><h1 style=\"text-align: left\">INCORPORATION DES COMPOSANTS DE LA PHASE INTERNE AU NIVEAU DE LA BIN /INTRA GRANULA COUMPOUND TRANSFERT INTO THE BIN FRACTION 1</h1><p style=\"text-align: left\">Equipement</p><table style=\"min-width: 75px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Désignation équipement/equipment designation</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Code</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Dernière date de qualification/étalonnage / last calibration and qualification date</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Isolateur de pesée /weighing isolator</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">EQ HP ECE 04</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Balance de pesée /weighing scale</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">EQ HP DSM 02</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Bin</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">EQ HP MTB</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><p style=\"text-align: left\">Date et heure début/starting date and hour</p><ol><li><p style=\"text-align: left\">Vérifier le vide de ligne et le nettoyage de la balance et de l\'isolateur de pesée /check the line clearance of the weighing isolator and scale</p></li></ol><table style=\"min-width: 50px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa/checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"2\"><li><p style=\"text-align: left\">Vérifier la conformité des paramètres de l\'environnement /check the conformity of environnement parameter</p></li></ol><table style=\"min-width: 125px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Paramètre</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Norme</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Valeur lue/value</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">21±3°C</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">55±10%</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">20±5 Pa</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"3\"><li><p style=\"text-align: left\">Indiquer le produit précédemment fabriqué ainsi que son n° de lot /indicate the previous product manufactured and the corresponding batch number</p></li><li><p style=\"text-align: left\">Vérifier la disponibilité et /ou le nettoyage des accessoires de pesée /check the availability and /or the cleaning of weighing tool</p></li></ol><table style=\"min-width: 50px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa/checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"5\"><li><p style=\"text-align: left\">Vérifier l’étalonnage de la balance/check the scale calibration</p></li></ol><table style=\"min-width: 50px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa/checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"6\"><li><p style=\"text-align: left\">Entamer le test d\'étanchéité automatique de l\'isolateur /start the isolator leak test</p></li></ol><table style=\"min-width: 100px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Test d\'étanchéité</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Résultat/result</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Préchambre /pre chamber 1</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Chambre principale</p><p style=\"text-align: left\">/main chamber 2:</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><p style=\"text-align: left\">Si non conforme refaire le test , si la non conformité persiste informer votre supérieur hiérarchique./ if the test is non-compliant repeat the test, if non conformity persists inform your supervisor</p><table style=\"min-width: 50px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Test conforme</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Test non conforme</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"7\"><li><p style=\"text-align: left\">Indiquer les paramètres suivants /indicate the following parameters :</p></li></ol><table style=\"min-width: 125px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Paramètre</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Consigne/set</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Valeur/value</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa /checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Pression préchambre</p><p style=\"text-align: left\">/prechamber pressure</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">-75 PA</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Pression chambre principale / Main chamber pressure</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">-100 PA</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"8\"><li><p style=\"text-align: left\">Vérifier le nettoyage de la bin selon l’instruction en vigueur /check the bin cleaning according SOP</p></li></ol><table style=\"min-width: 100px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Code bin/bin code</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Poids bin vide /empty bin weight</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><p style=\"text-align: left\">Joindre étiquette pesée /attach weighing label</p><table style=\"min-width: 50px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa/checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"9\"><li><p style=\"text-align: left\">Effectuer la connexion de la bin à la vanne active de l\'isolateur de pesée /carry out the bin connection to the weighing isolator active valve</p></li></ol><table style=\"min-width: 50px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa/checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"10\"><li><p style=\"text-align: left\">Entamer le cycle de nettoyage /start the cleaning cycle</p></li></ol><table style=\"min-width: 50px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa/checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"11\"><li><p style=\"text-align: left\">A la fin du cycle ouvrir la twin valve /at the end of the cycle open the twin valve</p></li></ol><table style=\"min-width: 100px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p><img class=\"editor-image\" src=\"media/image1.png\"></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"><strong>DOSSIER DE FABRICATION</strong></p><p style=\"text-align: left\"><strong>Manufacturing batch record</strong></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Page 23 / 112</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"><strong>DT-PN-0145</strong></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Version : 01</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">LETROZOLE NEAPOLIS 2.5 MG COMPRIME PELLICULE</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">NUMERO DE LOT</p><p style=\"text-align: left\">Batch number LETZ-5T030-205</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa/checked by date and signature</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"12\"><li><p style=\"text-align: left\">Introduire respectivement au niveau de la première chambre de l\'isolateur les matières pesées après avoir désinfecté le sac externe à l’éthanol 70%/introduce in the first chamber of isolator the weighed material after external bag disinfection with ethanol 70%</p></li></ol><table style=\"min-width: 50px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa/checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"13\"><li><p style=\"text-align: left\">Ouvrir la porte entre les 2 chambres faire passer les intrants à la chambre principale après avoir enlever le sac externe /Open the door between the 2 chambers to pass the inputs to the main chamber after removing the external bag</p></li></ol><table style=\"min-width: 50px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa/checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"14\"><li><p style=\"text-align: left\">Effectuer la double pesée de chaque matière et joindre les étiquettes correspondantes /carry out the double weighing of each material and attach the corresponding label</p></li><li><p style=\"text-align: left\">Introduire la quantité pesée du PA dans un double sac en polyetylene /put the weighed quantity of API in a double PE BAG</p></li></ol><table style=\"min-width: 75px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Letrozole(g)</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa/checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><p style=\"text-align: left\">Joindre étiquette double pesée /attach double weighing label</p><ol start=\"16\"><li><p style=\"text-align: left\">Ajouter la fraction F1 du lactose monhydrate (10%) /add the fraction 1 of lactose monohydrate (10%)</p></li></ol><table style=\"min-width: 75px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Lactose monohydrate F1 (10%)</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa/checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><p style=\"text-align: left\">Joindre étiquette double pesée /attach double weighing label</p><ol start=\"17\"><li><p style=\"text-align: left\">Vérifier l\'intégrité et le nettoyage du tamis 800µ / Check the integrity and cleaning of 800 µ siever code EQ HP ECE 04 07</p></li></ol><table style=\"min-width: 50px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa/checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"18\"><li><p style=\"text-align: left\">Effectuer le mélange manuel et le tamisage des 2 composants à travers ce tamis./mix manually and sieve the mixture through this seive</p></li><li><p style=\"text-align: left\">Incorporer le mélange tamisé au niveau de la bin /introduce the sieved mixture inside the bin</p></li></ol><table style=\"min-width: 50px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa/checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"20\"><li><p style=\"text-align: left\">Vérifier l\'intégrité du tamis 800µ après le transfert / Check the integrity 800 µ siever after transfer</p></li></ol><table style=\"min-width: 50px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa/checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"21\"><li><p style=\"text-align: left\">Vérifier l\'intégrité et le nettoyage du tamis 1mm / Check the integrity and cleaning of 1mm siever code EQ HP ECE 04 04</p></li></ol><table style=\"min-width: 50px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa/checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"22\"><li><p style=\"text-align: left\">Effectuer le tamisage à travers le tamis 1mm des autres composants et les incorporer selon l\'ordre suivant : /Carry out the sifting of the excipients through the siever 1 mm and introduce them according the following order</p></li></ol><p style=\"text-align: left\">Joindre étiquette double pesée /attach double weighing label</p><ol start=\"23\"><li><p style=\"text-align: left\">Vérifier l\'intégrité du tamis 1mm après le transfert / Check the integrity 1mm siever after transfer</p></li></ol><table style=\"min-width: 50px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa/checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"24\"><li><p style=\"text-align: left\">A la fin du transfert fermer la bin et entamer le cycle de nettoyage avant déconnexion /at the end of transfer close the bin and start the cleaning cycle before disconnection</p></li></ol><table style=\"min-width: 50px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa/checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"25\"><li><p style=\"text-align: left\">Relever le poids de la bin remplie/indicate the weight of filled bin</p></li></ol><table style=\"min-width: 125px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Code bin</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Poids bin vide/weight empty bin</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Poids bin remplie</p><p style=\"text-align: left\">/weight filled bin</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa/checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"26\"><li><p style=\"text-align: left\">A la fin récupérer le déchet à travers le liner /At the end collect the waste and take them out through the liner</p></li><li><p style=\"text-align: left\">Effectuer le nettoyage de l’isolateur, de la balance et des tamis selon la l\'instruction code DO- PN-0092/116 /clean the isolator scale and sievers according to the SOP code DO-PN-0092/116</p></li></ol><table style=\"min-width: 50px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa/checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><p style=\"text-align: left\">Date et heure fin ending date and hour</p><p style=\"text-align: left\">Visa et date superviseur/signature and date supervisor</p><p style=\"text-align: left\">Joindre le vide de ligne de l\'equipement et l\'étiquette statut local/attach the equipment line clearance label and cleaning label of room</p><h1 style=\"text-align: left\">PREPARATION DE LA SOLUTION DE GRANULATION /GRANULATION SOLUTION PREPARATION FRACTION 1</h1><p style=\"text-align: left\">Equipement</p><table style=\"min-width: 75px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Désignation équipement/equipment designation</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Code / code</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Dernière date de qualification/étalonnage /last calibration and qualification date</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Balance preparation granulation</p><p style=\"text-align: left\">/granulation solution preparation scale</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">EQ HP DSM 06</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Agitateur /mixer</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">EQ HP EFH 22</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><p style=\"text-align: left\">Date et heure début/starting date and hour</p><ol><li><p style=\"text-align: left\">Vérifier le vide de ligne et le nettoyage du local et de la balance de préparation de la solution de granulation et du becher de 5 litres /check the line clearance of granulation solution preparation room and scale and 5 liters beaker</p></li><li><p style=\"text-align: left\">Effectuer un prélèvement de l’EP du jour pour le contrôle qualité/carry out a sampling of purified water for QC</p></li></ol><table style=\"min-width: 50px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa/checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"3\"><li><p style=\"text-align: left\">Vérifier la conformité des paramètres de l\'environnement /check the conformity of environnement parameter</p></li></ol><table style=\"min-width: 125px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Norme</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Valeur/value</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa /checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Température</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">21±3°C</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Humidité</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">55±10%</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Pression</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">0±5 Pa</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"4\"><li><p style=\"text-align: left\">Effectuer le calibrage interne de la balance /start the scale calibration</p></li></ol><table style=\"min-width: 50px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa/checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"5\"><li><p style=\"text-align: left\">Introduire 1.3 kg d\'EP/introduce 1.3 kg PW</p></li></ol><p style=\"text-align: left\">Joindre l’étiquette de pesée /attach the weighing label</p><ol start=\"6\"><li><p style=\"text-align: left\">A la fin de la préparation, introduire la solution dans le réservoir du granulateur /at the end of preparation introduce the solution in the granulator container</p></li></ol><table style=\"min-width: 50px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa/checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"7\"><li><p style=\"text-align: left\">Vérifier la buse de pulvérisation et régler le débit de pulvérisation /check the spraying nozzel and set the sparying flow</p></li></ol><table style=\"min-width: 125px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Paramètre/parame ter</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Consigne/set</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Valeur/value</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Debit de pulvérisation</p><p style=\"text-align: left\">/Spraying flow</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Norme 160 g-180 g</p><p style=\"text-align: left\">/min</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Type de buse</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Norme 8SS</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><p style=\"text-align: left\">Date et heure fin ending hour and date</p><p style=\"text-align: left\">Visa et date superviseur/ signature and date supervisor</p><p style=\"text-align: left\">Joindre le vide de ligne et l\'étiquette de nettoyage du becher, , balance préparation de la solution granulation et l\'étiquette statut local/attach cleaning label of beaker, , granulation solution preparation scale, granulation preparation room</p><h1 style=\"text-align: left\">MELANGE, GRANULATION, SECHAGE CALIBRAGE /DRY BLENDING, GRANULATION, DRYING MILLING FRACTION 1</h1><p style=\"text-align: left\">Equipement</p><table style=\"min-width: 75px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Désignation équipement/equipment designation</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Code /code</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Dernière date de qualification/étalonnage / last calibration and qualification date</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">granulateur/ granulator</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">EQ HP EFH 01</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Bin de déchargement /discharge bin</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">EQ HP MTB</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Dessicateur halogène/halogen moisture analyser</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">EQ HP ELQ 04</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><p style=\"text-align: left\">Date et heure début starting date and hour</p><h1 style=\"text-align: left\">10. 1. OPERATIONS PRELIMINIARES /PRELIMINARY OPERATIONS</h1><ol><li><p style=\"text-align: left\">Vérifier le vide de ligne du local granulation et du mélangeur granulateur /check the line clearance of the granulation room and the granulator</p></li></ol><table style=\"min-width: 50px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa/checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"2\"><li><p style=\"text-align: left\">Vérifier la conformité des paramètres de l\'environnement /check the conformity of environnement parameter</p></li></ol><table style=\"min-width: 125px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Norme</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Valeur lue/value</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa/checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Temperature</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">21±3°C</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Humidité</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">55±10%</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Pression</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">10±5 Pa</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"3\"><li><p style=\"text-align: left\">Installer les 2 filtres casse vide et système échantillonage indiquer leurs numéros de serie/ Install the 2 filters , vacuum break and sampling system indicate their serial numbers</p></li><li><p style=\"text-align: left\">Vérifier l’intégrité du calibreur / check the mill integrity</p></li></ol><table style=\"min-width: 50px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa/checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"5\"><li><p style=\"text-align: left\">Effectuer la connexion de la bin de chargement à la vanne active du granulateur selon l\'instruction en vigueur /start the conection of the loading bin to the active valve of the granulator according SOP</p></li></ol><table style=\"min-width: 50px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa/checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"6\"><li><p style=\"text-align: left\">Entamer le cycle de nettoyage de la twin valve selon l\'instruction en vigueur/start the cleaning cycle of the twin valve according SOP</p></li></ol><table style=\"min-width: 50px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa/checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"7\"><li><p style=\"text-align: left\">Vérifier le nettoyage de la bin/check the bin cleaning</p></li></ol><table style=\"min-width: 100px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Code bin /bin code</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Poids bin vide /weight empty bin</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa</p><p style=\"text-align: left\">/done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa/checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><p style=\"text-align: left\">Coller étiquette de pesée signée/attach weighing label</p><ol start=\"8\"><li><p style=\"text-align: left\">Effectuer la connexion de la bin de déchargement à la vanne active de déchargement du granulateur</p></li></ol><p style=\"text-align: left\">/carry out the connexion of the unloading bin to the active discharge valve</p><table style=\"min-width: 50px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa/checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"9\"><li><p style=\"text-align: left\">Entamer le cycle de nettoyage de la Twin valve/start the twin valve cleaning cycle</p></li></ol><table style=\"min-width: 50px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa/checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><h1 style=\"text-align: left\">2. CHARGEMENT DE LA POUDRE /POWDER LOADING</h1><p style=\"text-align: left\">10. A la fin du cycle de nettoyage de la twin valve, ouvrir la vanne passive de la bin et commencer le chargement de la poudre /at the end of the cleaning cycle , open the bin passive valve and start powder loading</p><table style=\"min-width: 50px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa /checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"11\"><li><p style=\"text-align: left\">Indiquer les paramètres suivants /indicate the following parameters: Temps/time</p></li></ol><table style=\"min-width: 100px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Consigne/set</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">H debut /starting</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">H fin/ending</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Temps/time</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">3-9 min</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><p style=\"text-align: left\">Vitesse</p><table style=\"min-width: 50px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa /checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><h1 style=\"text-align: left\">3. MELANGE DES POUDRES/ BLENDING</h1><ol start=\"12\"><li><p style=\"text-align: left\">Indiquer les paramètres suivants /indicate the following parameters: Temps/time</p></li></ol><table style=\"min-width: 100px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">H debut /starting</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Consigne/set</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">H fin/ending</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Temps /time</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">5 min</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><p style=\"text-align: left\">Vitesse</p><table style=\"min-width: 75px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Consigne/set</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Valeur lue/value</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vitesse pale /impeller speed</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">80 rpm</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><p style=\"text-align: left\">Fait par/Vérifié par</p><table style=\"min-width: 50px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa/checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><h1 style=\"text-align: left\">4. PLUVERISATION ET GRANULATION /SPRAYING AND GRANULATION</h1><ol start=\"13\"><li><p style=\"text-align: left\">Première phase/phase 1 : indiquer les paramètres suivants /indicate the following parameter Type de buse/nozzle type</p></li></ol><table style=\"min-width: 75px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Consigne/set</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Valeur lue/value</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Type de buse /nozzle type</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Nozzle 8 SS</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><p style=\"text-align: left\">Temps/time</p><table style=\"min-width: 100px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Consigne/set</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">H debut /starting</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">H fin/ending</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Temps/time</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">5 min ± 1 min</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><p style=\"text-align: left\">Vitesse</p><table style=\"min-width: 75px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Consigne/set</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Valeur lue/value</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vitesse pale /impeller speed</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">80 rpm</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vitesse chopper /chopper speed</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">0 rpm</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><p style=\"text-align: left\">Pression</p><table style=\"min-width: 75px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Consigne/set</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Valeur lue/value</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Pression solution de granulation</p><p style=\"text-align: left\">/pressure binder solution</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">0.2 MPA</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><p style=\"text-align: left\">Quantité solution pulvérisée/sprayed solution Quantity</p><table style=\"min-width: 75px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Consigne/set</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Valeur lue/value</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Quantité solution pulvérisée/sprayed solution Quantity</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">900 g</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><table style=\"min-width: 50px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa /checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"14\"><li><p style=\"text-align: left\">Deuxième phase/phase 2 : indiquer les paramètres suivants /indicate the following parameter Temps/time</p></li></ol><table style=\"min-width: 100px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Consigne/set</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">H debut /starting</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">H fin/ending</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Temps/time</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">2-3 min</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><p style=\"text-align: left\">Vitesse</p><table style=\"min-width: 75px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Consigne/set</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Valeur lue/value</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vitesse pale /impeller speed</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">80 rpm</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vitesse chopper /chopper speed</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">1200 rpm</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><p style=\"text-align: left\">Pression</p><table style=\"min-width: 75px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Consigne/set</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Valeur lue/value</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Pression solution de granulation</p><p style=\"text-align: left\">/pressure binder solution</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">0.2 MPA</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><p style=\"text-align: left\">Quantité solution pulvérisée/sprayed solution Quantity</p><table style=\"min-width: 75px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Consigne/set</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Valeur lue/value</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Quantité solution pulvérisée/sprayed solution Quantity</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">400 g</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><p style=\"text-align: left\">Fait par/Vérifié par</p><table style=\"min-width: 50px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa /checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><h1 style=\"text-align: left\">5. SECHAGE /DRYING</h1><ol start=\"15\"><li><p style=\"text-align: left\">Première phase/phase 1 : indiquer les paramètres suivants /indicate the following parameter Temps/time</p></li></ol><table style=\"min-width: 100px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Consigne/set</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">H debut /starting</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">H fin/ending</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Temps/time</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">20 min</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><p style=\"text-align: left\">Vitesse</p><table style=\"min-width: 75px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Consigne/set</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Valeur lue/value</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vitesse pale /impeller speed</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">0 rpm</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vitesse chopper /chopper speed</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">0 rpm</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><p style=\"text-align: left\">Température</p><table style=\"min-width: 150px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p><img class=\"editor-image\" src=\"media/image1.png\"></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"><strong>DOSSIER DE FABRICATION</strong></p><p style=\"text-align: left\"><strong>Manufacturing batch record</strong></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Page 32 / 112</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"><strong>DT-PN-0145</strong></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Version : 01</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">LETROZOLE NEAPOLIS 2.5 MG COMPRIME PELLICULE</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">NUMERO DE LOT</p><p style=\"text-align: left\">Batch number LETZ-5T030-205</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Consigne/set</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Début /start</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Milieu/Middle</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fin/end</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Température double jacket</p><p style=\"text-align: left\">/jacket temperature</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">45±5°C</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Température max produit/ max product temperature</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">46-47°C</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><p style=\"text-align: left\">Pression</p><table style=\"min-width: 75px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Valeur lue/value</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Consigne/set</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Pression pompe à vide /pressure vaccum pump</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">0 mbar</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Pression chambre de granulation/granulation chamber pressure</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">137-160 mbar</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><p style=\"text-align: left\">Fait par/Vérifié par</p><table style=\"min-width: 50px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa /checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"16\"><li><p style=\"text-align: left\">Deuxième phase/phase 2: indiquer les paramètres suivants /indicate the following parameter Temps/time</p></li></ol><table style=\"min-width: 100px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Consigne/set</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">H debut /starting</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">H fin/ending</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Temps/time</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">2h50- 3h24</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><p style=\"text-align: left\">Vitesse</p><table style=\"min-width: 75px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Consigne/set</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Valeur lue/value</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vitesse pale intermittent/ impeller speed intermittent</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">20 rpm 20sec ON et 60 sec OFF</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vitesse chopper intermittentchopper speed intermittent</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">700 rpm 20sec ON et 60 sec OFF</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><p style=\"text-align: left\">Température</p><table style=\"min-width: 125px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Consigne/set</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Début /start</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Milieu/Middle</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fin/end</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Température double jacket</p><p style=\"text-align: left\">/jacket temperature</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">55±5°C</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Temperature produit /product temperature</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">46°C-47°C</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><p style=\"text-align: left\">Pression</p><table style=\"min-width: 150px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p><img class=\"editor-image\" src=\"media/image1.png\"></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"><strong>DOSSIER DE FABRICATION</strong></p><p style=\"text-align: left\"><strong>Manufacturing batch record</strong></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Page 33 / 112</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"><strong>DT-PN-0145</strong></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Version : 01</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">LETROZOLE NEAPOLIS 2.5 MG COMPRIME PELLICULE</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">NUMERO DE LOT</p><p style=\"text-align: left\">Batch number LETZ-5T030-205</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Consigne/set</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Début/ start</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Milieu/Middle</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fin/end</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Pression pompe à vide /pressure vaccum pump</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">0 mbar</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Pression chambre de granulation/gra nulation chamber pressure</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">137-160 mbar</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><p style=\"text-align: left\">Fait par/Vérifié par</p><table style=\"min-width: 50px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa /checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><p style=\"text-align: left\">Aspect granules</p><table style=\"min-width: 125px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Consigne/set</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Valeur lue/value</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa /checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Aspect granules</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Granules blanc à</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">/granules</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">blanc cassé avec</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">apperance</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">un aspect</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">conforme /white to</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">off white good</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">granules</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"17\"><li><p style=\"text-align: left\">A la fin du séchage effectuer le contrôle de l\'humidité résiduelle en prélevant un échantillon de 5 g à la température de 105°C (durée du test 4 min)</p></li></ol><table style=\"min-width: 125px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Consigne/set</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Valeur lue/value</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa/checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Humidité résiduelle/residual moisture</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">0.96-1.29 %</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><h1 style=\"text-align: left\">6. REFROIDISSMENT/COOLING</h1><ol start=\"18\"><li><p style=\"text-align: left\">Indiquer les paramètres suivants /indicate the following parameter Temps/time</p></li></ol><table style=\"min-width: 100px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Consigne/set</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">H debut /starting</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">H fin/ending</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Temps total/total time</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">2h50- 3h24</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><p style=\"text-align: left\">Vitesse</p><table style=\"min-width: 75px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Consigne/set</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Valeur lue/value</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vitesse pale intermittent (900s)/impeller speed intermittent</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">20 rpm 20sec ON et 60 sec OFF</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vitesse chopper /chopper speed</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">0 rpm</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><table style=\"min-width: 100px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p><img class=\"editor-image\" src=\"media/image1.png\"></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"><strong>DOSSIER DE FABRICATION</strong></p><p style=\"text-align: left\"><strong>Manufacturing batch record</strong></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Page 34 / 112</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"><strong>DT-PN-0145</strong></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Version : 01</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">LETROZOLE NEAPOLIS 2.5 MG COMPRIME PELLICULE</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">NUMERO DE LOT</p><p style=\"text-align: left\">Batch number LETZ-5T030-205</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><p style=\"text-align: left\">Température</p><table style=\"min-width: 125px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Consigne/set</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Début /start</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Milieu/Middle</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fin/end</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Température double jacket</p><p style=\"text-align: left\">/jacket temperature</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">10±5°C</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Température produit /product temperature</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">&lt;=25°C</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><p style=\"text-align: left\">Pression</p><table style=\"min-width: 125px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Consigne/set</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Début/ start</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Milieu/Middle</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fin/end</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Pression pompe à vide /vacuum pump pressure</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">0 mbar</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Pression chambre de granulation/gra nulation chamber pressure</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">&lt;=136-153 mbar</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><p style=\"text-align: left\">Fait par/Vérifié par</p><table style=\"min-width: 50px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa /checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><h1 style=\"text-align: left\">7. CALIBRAGE /MILLING</h1><ol><li><p style=\"text-align: left\">Vérifier la connexion de la bin de déchargement à la valve active de déchargement du granulateur / check the discharge bin connection to the active valve of the granulator</p></li></ol><table style=\"min-width: 50px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa/checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"2\"><li><p style=\"text-align: left\">Ouvrir manuellement la vanne passive de la bin /open manually the bin passive valve</p></li></ol><table style=\"min-width: 50px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa/checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"3\"><li><p style=\"text-align: left\">Indiquer les paramètres suivants /indicate the following parameter Temps/time</p></li></ol><table style=\"min-width: 100px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Consigne/set</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">H debut /starting</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">H fin/ending</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Temps total/total time</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Indicatif</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><p style=\"text-align: left\">Vitesse</p><table style=\"min-width: 100px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p><img class=\"editor-image\" src=\"media/image1.png\"></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"><strong>DOSSIER DE FABRICATION</strong></p><p style=\"text-align: left\"><strong>Manufacturing batch record</strong></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Page 35 / 112</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"><strong>DT-PN-0145</strong></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Version : 01</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">LETROZOLE NEAPOLIS 2.5 MG COMPRIME PELLICULE</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">NUMERO DE LOT</p><p style=\"text-align: left\">Batch number LETZ-5T030-205</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Consigne/set</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Valeur lue/value</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vitesse calibreur /mill speed</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">1000 rpm</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Diamètre calibreur / mill diameter</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">1.5 mm</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vitesse pale intermittent</p><p style=\"text-align: left\">/impeller speed intermittent</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">20 rpm 5 sec ON et 5 sec OFF</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><p style=\"text-align: left\">Fait par/Vérifié par</p><table style=\"min-width: 50px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa/checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"4\"><li><p style=\"text-align: left\">A la fin du déchargement effectuer le nettoyage de la twin valve et la déconnexion de la bin de décharge /at the end of unlaoding carry out the twin valve cleaning and discharge bin disconnection</p></li></ol><table style=\"min-width: 50px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa/checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"5\"><li><p style=\"text-align: left\">Procéder au montage des raccordements de nettoyage et démarrer le nettoyage en place. /Install the cleaning connections and start the CIP</p></li></ol><table style=\"min-width: 50px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa/checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"6\"><li><p style=\"text-align: left\">A la fin du nettoyage verifier l’intégrité du calibreur / check the mill integrity</p></li></ol><table style=\"min-width: 50px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa/checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><p style=\"text-align: left\">Date et heure fin/ ending date and hour</p><p style=\"text-align: left\">Visa et date superviseur signature and date supervisor</p><p style=\"text-align: left\">Joindre le vide de ligne de l\'equipement et l\'étiquette statut local/attach the equipment line clearance label and cleaning label of room</p><p style=\"text-align: left\">Fiche suivi granulation+séchage +refroidissement +calibrage / Granulation+drying+cooling+milling tracking sheet</p><table style=\"min-width: 125px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p><img class=\"editor-image\" src=\"media/image1.png\"></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"><strong>DOSSIER DE FABRICATION</strong></p><p style=\"text-align: left\"><strong>Manufacturing batch record</strong></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Page 36 / 112</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"><strong>DT-PN-0145</strong></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Version : 01</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">LETROZOLE NEAPOLIS 2.5 MG COMPRIME PELLICULE</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">NUMERO DE LOT</p><p style=\"text-align: left\">Batch number LETZ-5T030-205</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Heure/hour</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Type d\'intervention/inter vention type</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par/done by</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Signature /signature</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><p style=\"text-align: left\">Signature</p><h1 style=\"text-align: left\">PESÉE DES EXCIPIENTS PHASE INTERNE /WEIGHING INTRA GRANULA EXCIPIENTS FRACTION 2</h1><p style=\"text-align: left\">Equipement</p><table style=\"min-width: 75px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Désignation équipement/equipment designation</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Code</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Dernière date de qualification/étalonnage last calibration and qualification date</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Centrale de pesée /weighing booth</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">EQ HP ECE 03</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Balance de pesée /weighing scale</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">EQHP DSM 01</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><p style=\"text-align: left\">Date et heure début/starting date and hour</p><ol><li><p style=\"text-align: left\">Vérifier le vide de ligne et le nettoyage de la balance et de la centrale de pesée /check the line clearance and the cleaning of the weighing booth and scale</p></li><li><p style=\"text-align: left\">Vérifier la conformité des paramètres de l\'environnement /check the conformity of environnement parameter</p></li></ol><table style=\"min-width: 125px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Norme</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Valeur lue/value</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Temperature</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">21±3°C</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Humidité /humidity</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">55±10%</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Pression</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">20±5 Pa</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"3\"><li><p style=\"text-align: left\">Indiquer le produit précédemment fabriqué ainsi que son n° de lot /indicate the previous product manufactured and the corresponding batch number</p></li></ol><table style=\"min-width: 100px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Désignation /designation</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Numéro de lot/batch number</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa</p><p style=\"text-align: left\">/done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa/checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"4\"><li><p style=\"text-align: left\">Vérifier la disponibilité et /ou le nettoyage des accessoires de pesée /check the availability and /or the cleaning of weighing tool</p></li><li><p style=\"text-align: left\">Vérifier l\'étalonnage de la balance/ check the scale calibration</p></li></ol><table style=\"min-width: 50px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa/checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"6\"><li><p style=\"text-align: left\">Coller une étiquette d\'identification code DT-PN-0252 sur les sacs pour chaque intrant à pesée / Stick an identification label code DT-PN-0252 on the bags for each input to be weighed</p></li><li><p style=\"text-align: left\">Effectuer les pesées selon l\'instruction en code DO-PN-100 /start the weighing according SOP code DO-PN-100 : La quantité de matière à peser est calculée selon l’équation suivante</p></li></ol><table style=\"min-width: 50px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Pesée à partir d’un seul lot de titre T/weighing from only one batch with assay: T</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Pesée à partir de deux lots de titres respectifs T1 et T2 / weighing from 2 different batches with assay T1 and T2</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Q=Qn*(100/T) avec : Q : Quantité de matière à peser./ Quantity of material to be weighed Qn : Quantité theorique /theoritical quantity T : titre du produit ./assay Calcul/calculation :</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Soit Q1 la quantité de matière qui reste du lot N°1 de titre T1/ Q1 the quantity of material that remains from batch N ° 1 with assay T1 Soit Q2 la quantité de matière qui doit être pesée du lot numéro 2 de titre T2 The quantity Q2 of material that must be weighed from batch N ° 2 with assay T2 Q2=(100/T2)*[(Qn-((Q1*T1)/100))] Lot N°1 T1 =</p><p style=\"text-align: left\">....................... Lot N°2 T2 = Q1 =</p><p style=\"text-align: left\">....................... Q2 = ......................</p></td></tr></tbody></table><ol start=\"8\"><li><p style=\"text-align: left\">A la fin de la pesée effectuer un nettoyage de la centrale, de la balance et du local /at the end of weighing start the cleaning of dispensing booth , scale and room</p></li></ol><table style=\"min-width: 50px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa/checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><p style=\"text-align: left\">Observations</p><p style=\"text-align: left\">Date et heure fin /ending date and hour</p><p style=\"text-align: left\">Visa et date superviseur/signature and date supervisor</p><p style=\"text-align: left\">Joindre le vide de ligne de l\'equipement/local et l\'étiquette statut local/attach the equipment/room line clearance label and cleaning label of room</p><h1 style=\"text-align: left\">PESÉE DE LA MATIERE ACTIVE PHASE INTERNE /WEIGHINGINTRA GRANULA : ACTIVE INGREDIENT FRACTION 2</h1><p style=\"text-align: left\">Equipement</p><table style=\"min-width: 75px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Désignation équipement/equipment designation</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Code</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Dernière date de qualification/étalonnage last calibration and qualification date</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Isolateur de pesée /weighing isolator</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">EQ HP ECE 04</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Balance de pesée /weighing scale</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">EQ HP DSM 02</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><p style=\"text-align: left\">Date et heure début/starting date and hour</p><ol><li><p style=\"text-align: left\">Vérifier le vide de ligne et le nettoyage de la balance et de l’isolateur de pesée / check the line clearance of the weighing isolator and scale</p></li><li><p style=\"text-align: left\">Vérifier la conformité des paramètres de l\'environnement /check the conformity of environnement parameter</p></li></ol><table style=\"min-width: 125px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Norme</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Valeur lue/value</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa /checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Température</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">100</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Humidité</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">50</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Pression</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">20</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"3\"><li><p style=\"text-align: left\">Indiquer le produit précédemment fabriqué ainsi que son n° de lot /indicate the previous product manufactured and the corresponding batch number</p></li></ol><table style=\"min-width: 100px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Désignation/designation</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Numéro de lot/batch number</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"4\"><li><p style=\"text-align: left\">Vérifier la disponibilité et /ou le nettoyage des accessoires de pesée /check the availability and /or the cleaning of weighing tool</p></li><li><p style=\"text-align: left\">Vérifier l\'étalonnage de la balance / check the scale calibration</p></li></ol><table style=\"min-width: 50px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa/checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"6\"><li><p style=\"text-align: left\">Entamer le test d\'étanchéité automatique de l\'isolateur /start the isolator leak test</p></li></ol><table style=\"min-width: 100px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Test d\'étanchéité</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Résultat/result</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><p style=\"text-align: left\">Si non conforme refaire le test , si la non conformité persiste informer votre supérieur hiérarchique./ if the test is non-compliant repeat the test, if non conformity persists inform your supervisor</p><table style=\"min-width: 50px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Test conforme</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Test non conforme</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"8\"><li><p style=\"text-align: left\">Coller une étiquette d\'identification code DT-PN-0252 sur les sacs pour chaque intrant à peser / Stick an identification label code DT-PN- 0252 on the bags for each input to be weighed</p></li></ol><table style=\"min-width: 50px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa/checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"9\"><li><p style=\"text-align: left\">Introduire respectivement au niveau de la première chambre de l\'isolateur les accessoires de pesée à usage unique , le conteneur de la matière première après essuyage à éthanol 70%, tissu de nettoyage, sac de pesée étiqueté</p></li><li><p style=\"text-align: left\">Ouvrir le conteneur de la matière première ; récupérer le sac interne , le poser sur le plateau ,enlever le 1er sac effectuer une désinfection de et le faire entrer au niveau de la chambre de pesée</p></li></ol><table style=\"min-width: 50px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa/checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"11\"><li><p style=\"text-align: left\">Effectuer la pesée selon l\'instruction code DO-PN-108 /carry out weighing according SOP code DO- PN-108: La quantité de matière à peser est calculée selon l\'équation suivante :</p></li></ol><table style=\"min-width: 50px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Pesée à partir d’un seul lot de titre T/weighing from only one batch with assay: T</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Pesée à partir de deux lots de titres respectifs T1 et T2 / weighing from 2 different batches with assay T1 and T2</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Q=Qn*(100/T) Avec : Q : Quantité de matière à peser./ Quantity of material to be weighed Qn : Quantité theorique /theoritical quantity T : titre du produit ./assay Calcul/calculation :</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Soit Q1 la quantité de matière qui reste du lot N°1 de titre T1/ Q1 the quantity of material that remains from the batch N ° 1 with assay T1 Soit Q2 la quantité de matière qui doit être pesée du lot numéro 2 de titre T2/The quantity Q2 of material that must be weighed from batch N ° 2 with assay T2 Q2=(100/T)*[(Qn-((Q1*T1)/100))] Lot N°1 T1 =</p><p style=\"text-align: left\">....................... Lot N°2 T2 = Q1 =</p><p style=\"text-align: left\">....................... Q2 = ......................</p></td></tr></tbody></table><ol start=\"12\"><li><p style=\"text-align: left\">Fermer le sac de matière à retourner à l\'aide d\'un sert câble, essuyer la surface externe de ce dernier avec de l’éthanol 70% et le faire sortir à travers le liner</p></li><li><p style=\"text-align: left\">A la fin récupérer les déchets et les accessoires de pesée à usage unique et le faire sortir à travers le liner /At the end collect the waste and single use weighing accessories and take them out through the liner</p></li></ol><table style=\"min-width: 50px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa/checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"14\"><li><p style=\"text-align: left\">Effectuer le nettoyage de l\'isolateur et la balanceselon l\'instruction en code DO-PN-0092 /clean the isolator and scale according to the SOP code DO-PN-0092</p></li></ol><table style=\"min-width: 50px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa/checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><p style=\"text-align: left\">Observations</p><p style=\"text-align: left\">Date et heure fin/ending date and hour</p><p style=\"text-align: left\">Visa et date superviseur /signature and date supervisor</p><p style=\"text-align: left\">Joindre le vide de ligne de l’equipement et l’etiquette statut local/accessoire et équipement / attach the equipment line clearance label and cleaning label of room, accessories and equipements.</p><table style=\"min-width: 100px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p><img class=\"editor-image\" src=\"media/image1.png\"></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"><strong>DOSSIER DE FABRICATION</strong></p><p style=\"text-align: left\"><strong>Manufacturing batch record</strong></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Page 42 / 112</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"><strong>DT-PN-0145</strong></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Version : 01</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">LETROZOLE NEAPOLIS 2.5 MG COMPRIME PELLICULE</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">NUMERO DE LOT</p><p style=\"text-align: left\">Batch number LETZ-5T030-205</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><table style=\"min-width: 275px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">FICHE PESEE FRACTION 2/WEIGHING SHEET FRACTION 2</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Code/code</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Désignation/designation</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">N° de lot/batch number</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Titre/assay</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Quantité no menclature/t he theoretical</p><p style=\"text-align: left\">quantity</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Quantité à p eser/quantit y to weigh</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Quantité pes ée/quantity weighed</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Code balanc e/scale code</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par/done by</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par/checked by</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">MAN00007</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Phase interne</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Letrozole</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">125 g</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">EQHPDSM02</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">MAN00007</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Letrozole *</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">125 g</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">EQHPDSM02</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">MAN00001</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Lactose monhydrate</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">F1 : 250 g (10%) F2 :</p><p style=\"text-align: left\">1125 g</p><p style=\"text-align: left\">(45%) F3 :</p><p style=\"text-align: left\">1125 g(45%)</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">EQHPDSM01</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">MEN00012</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Cellulose mi crocristalline</p><p style=\"text-align: left\">ph 101</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">1400 g</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">EQHPDSM01</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">MAN00010</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Sodium</p><p style=\"text-align: left\">starch glycolate</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">75 g (60%)</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">EQHPDSM01</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">MAN00011</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Crospovidon</p><p style=\"text-align: left\">e</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">200 g</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">EQHPDSM01</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">MAN00041</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Liant</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Purified</p><p style=\"text-align: left\">water</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">QS 1.3 kg</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">EQHPDSM06</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><p style=\"text-align: left\"><strong>*si la matière à disposition appartient à 2 lots de titres différents / if the raw material belongs to two different batches having two different assay</strong></p><p style=\"text-align: left\"><strong>nombre de contanants / number of container:</strong></p><p style=\"text-align: left\"><strong>Joindre les étiquettes de pesée à cette page / attach the weighing label to this page</strong></p><h1 style=\"text-align: left\">INCORPORATION DES COMPOSANTS DE LA PHASE INTERNE AU NIVEAU DE LA BIN /INTRA GRANULA COUMPOUND TRANSFERT INTO THE BIN FRACTION 2</h1><p style=\"text-align: left\">Equipement</p><table style=\"min-width: 75px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Désignation équipement/equipment designation</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Code</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Dernière date de qualification/étalonnage / last calibration and qualification date</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Isolateur de pesée /weighing isolator</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">EQ HP ECE 04</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Balance de pesée /weighing scale</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">EQ HP DSM 02</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Bin</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">EQ HP MTB</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><p style=\"text-align: left\">Date et heure début/starting date and hour</p><ol><li><p style=\"text-align: left\">Vérifier le vide de ligne et le nettoyage de la balance et de l\'isolateur de pesée /check the line clearance of the weighing isolator and scale</p></li></ol><table style=\"min-width: 50px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa/checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"2\"><li><p style=\"text-align: left\">Vérifier la conformité des paramètres de l\'environnement /check the conformity of environnement parameter</p></li></ol><table style=\"min-width: 125px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Norme</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Valeur lue/value</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Temperature</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">21±3°C</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Humidité /humidity</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">55±10%</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Pression</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">20±5 Pa</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"3\"><li><p style=\"text-align: left\">Indiquer le produit précédemment fabriqué ainsi que son n° de lot /indicate the previous product manufactured and the corresponding batch number</p></li><li><p style=\"text-align: left\">Vérifier la disponibilité et /ou le nettoyage des accessoires de pesée /check the availability and /or the cleaning of weighing tool</p></li></ol><table style=\"min-width: 50px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa/checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"5\"><li><p style=\"text-align: left\">Vérifier l’étalonnage de la balance/check the scale calibration</p></li></ol><table style=\"min-width: 50px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa/checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"6\"><li><p style=\"text-align: left\">Entamer le test d\'étanchéité automatique de l\'isolateur /start the isolator leak test</p></li></ol><table style=\"min-width: 100px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Test d\'étanchéité</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Résultat/result</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><p style=\"text-align: left\">Si non conforme refaire le test , si la non conformité persiste informer votre supérieur hiérarchique./ if the test is non-compliant repeat the test, if non conformity persists inform your supervisor</p><table style=\"min-width: 50px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Test conforme</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Test non conforme</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"7\"><li><p style=\"text-align: left\">Indiquer les paramètres suivants /indicate the following parameters :</p></li></ol><table style=\"min-width: 125px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Paramètre</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Consigne/set</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Valeur/value</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Pression préchambre</p><p style=\"text-align: left\">/prechamber pressure</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">- 75 PA</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Pression chambre principale / Main chamber pressure</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">-100PA</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"8\"><li><p style=\"text-align: left\">Vérifier le nettoyage de la bin selon l’instruction en vigueur /check the bin cleaning according SOP</p></li></ol><table style=\"min-width: 100px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Code bin/bin code</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Poids bin vide /empty bin weight</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><p style=\"text-align: left\">Joindre étiquette pesée /attach weighing label</p><table style=\"min-width: 50px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa/checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"9\"><li><p style=\"text-align: left\">Effectuer la connexion de la bin à la vanne active de l\'isolateur de pesée /carry out the bin connection to the weighing isolator active valve</p></li></ol><table style=\"min-width: 50px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa/checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"10\"><li><p style=\"text-align: left\">Entamer le cycle de nettoyage /start the cleaning cycle</p></li></ol><table style=\"min-width: 50px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa/checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"11\"><li><p style=\"text-align: left\">A la fin du cycle ouvrir la twin valve /at the end of the cycle open the twin valve</p></li></ol><table style=\"min-width: 50px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa/checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"12\"><li><p style=\"text-align: left\">Introduire respectivement au niveau de la première chambre de l\'isolateur les matières pesées après avoir désinfecté le sac externe à l’éthanol 70%/introduce in the first chamber of isolator the weighed material after external bag disinfection with ethanol 70%</p></li></ol><table style=\"min-width: 100px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p><img class=\"editor-image\" src=\"media/image1.png\"></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"><strong>DOSSIER DE FABRICATION</strong></p><p style=\"text-align: left\"><strong>Manufacturing batch record</strong></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Page 45 / 112</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"><strong>DT-PN-0145</strong></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Version : 01</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">LETROZOLE NEAPOLIS 2.5 MG COMPRIME PELLICULE</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">NUMERO DE LOT</p><p style=\"text-align: left\">Batch number LETZ-5T030-205</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa/checked by date and signature</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"13\"><li><p style=\"text-align: left\">Ouvrir la porte entre les 2 chambres faire passer les intrants à la chambre principale après avoir enlever le sac externe /Open the door between the 2 chambers to pass the inputs to the main chamber after removing the external bag</p></li></ol><table style=\"min-width: 50px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa/checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"14\"><li><p style=\"text-align: left\">Effectuer la double pesée de chaque matière et joindre les étiquettes correspondantes /carry out the double weighing of each material and attach the corresponding label</p></li></ol><table style=\"min-width: 50px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa/checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"15\"><li><p style=\"text-align: left\">Introduire la quantité pesée du PA dans un double sac en polyetylene /put the weighed quantity of API in a double PE BAG</p></li></ol><p style=\"text-align: left\">Joindre étiquette double pesée /attach double weighing label</p><ol start=\"16\"><li><p style=\"text-align: left\">Ajouter la fraction F1 du lactose monhydrate (10%) /add the fraction 1 of lactose monohydrate (10%)</p></li></ol><table style=\"min-width: 75px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Lactose monohydrate F1 (10%)</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa/checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><p style=\"text-align: left\">Joindre étiquette double pesée /attach double weighing label</p><ol start=\"17\"><li><p style=\"text-align: left\">Vérifier l\'intégrité et le nettoyage du tamis 800µ / Check the integrity and cleaning of 800 µ siever code EQ HP ECE 04 07</p></li></ol><table style=\"min-width: 50px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa/checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"18\"><li><p style=\"text-align: left\">Effectuer le mélange manuel et le tamisage des 2 composants à travers ce tamis./mix manually and sieve the mixture through this seive</p></li></ol><table style=\"min-width: 50px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa/checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"19\"><li><p style=\"text-align: left\">Incorporer le mélange tamisé au niveau de la bin /introduce the sieved mixture inside the bin</p></li></ol><table style=\"min-width: 100px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p><img class=\"editor-image\" src=\"media/image1.png\"></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"><strong>DOSSIER DE FABRICATION</strong></p><p style=\"text-align: left\"><strong>Manufacturing batch record</strong></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Page 46 / 112</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"><strong>DT-PN-0145</strong></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Version : 01</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">LETROZOLE NEAPOLIS 2.5 MG COMPRIME PELLICULE</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">NUMERO DE LOT</p><p style=\"text-align: left\">Batch number LETZ-5T030-205</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"20\"><li><p style=\"text-align: left\">Vérifier l\'intégrité du tamis 800µ après le transfert / Check the integrity 800 µ siever after transfer</p></li></ol><table style=\"min-width: 50px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa/checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"21\"><li><p style=\"text-align: left\">Vérifier l\'intégrité et le nettoyage du tamis 1mm / Check the integrity and cleaning of 1mm siever code EQ HP ECE 04 04</p></li></ol><table style=\"min-width: 50px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa/checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"22\"><li><p style=\"text-align: left\">Effectuer le tamisage à travers le tamis 1mm des autres composants et les incorporer selon l\'ordre suivant : /Carry out the sifting of the excipients through the siever 1 mm and introduce them according the following order</p></li></ol><p style=\"text-align: left\">Joindre étiquette double pesée /attach double weighing label</p><ol start=\"23\"><li><p style=\"text-align: left\">Vérifier l\'intégrité du tamis 1mm après le transfert / Check the integrity 1mm siever after transfer</p></li></ol><table style=\"min-width: 50px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa/checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"24\"><li><p style=\"text-align: left\">A la fin du transfert fermer la bin et entamer le cycle de nettoyage avant déconnexion /at the end of transfer close the bin and start the cleaning cycle before disconnection</p></li></ol><table style=\"min-width: 50px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa/checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"25\"><li><p style=\"text-align: left\">Relever le poids de la bin remplie/indicate the weight of filled bin</p></li></ol><table style=\"min-width: 125px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Code bin</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Poids bin vide/weight empty bin</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Poids bin remplie</p><p style=\"text-align: left\">/weight filled bin</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa/checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"26\"><li><p style=\"text-align: left\">A la fin récupérer le déchet à travers le liner /At the end collect the waste and take them out through the liner</p></li></ol><table style=\"min-width: 50px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa/checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"27\"><li><p style=\"text-align: left\">Effectuer le nettoyage de l’isolateur, de la balance et des tamis selon la l\'instruction code DO- PN-0092/116 /clean the isolator scale and sievers according to the SOP code DO-PN-0092/116</p></li></ol><table style=\"min-width: 100px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p><img class=\"editor-image\" src=\"media/image1.png\"></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"><strong>DOSSIER DE FABRICATION</strong></p><p style=\"text-align: left\"><strong>Manufacturing batch record</strong></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Page 47 / 112</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"><strong>DT-PN-0145</strong></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Version : 01</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">LETROZOLE NEAPOLIS 2.5 MG COMPRIME PELLICULE</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">NUMERO DE LOT</p><p style=\"text-align: left\">Batch number LETZ-5T030-205</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa/checked by date and signature</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><p style=\"text-align: left\">Date et heure fin ending date and hour</p><p style=\"text-align: left\">Visa et date superviseur/signature and date supervisor</p><p style=\"text-align: left\">Joindre le vide de ligne de l\'equipement et l\'étiquette statut local/attach the equipment line clearance label and cleaning label of room</p><h1 style=\"text-align: left\">PREPARATION DE LA SOLUTION DE GRANULATION /GRANULATION SOLUTION PREPARATION FRACTION 2</h1><p style=\"text-align: left\">Equipement</p><table style=\"min-width: 75px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Désignation équipement/equipment designation</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Code / code</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Dernière date de qualification/étalonnage /last calibration and qualification date</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Balance preparation granulation</p><p style=\"text-align: left\">/granulation solution preparation scale</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">EQ HP DSM 06</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Agitateur /mixer</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">EQ HP EFH 22</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><p style=\"text-align: left\">Date et heure début/starting date and hour</p><ol><li><p style=\"text-align: left\">Vérifier le vide de ligne et le nettoyage du local et de la balance de préparation de la solution de granulation et du becher de 5 litres /check the line clearance of granulation solution preparation room and scale and 5 liters beaker</p></li><li><p style=\"text-align: left\">Effectuer un prélèvement de l’EP du jour pour le contrôle qualité/carry out a sampling of purified water for QC</p></li></ol><table style=\"min-width: 50px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa/checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"3\"><li><p style=\"text-align: left\">Vérifier la conformité des paramètres de l\'environnement /check the conformity of environnement parameter</p></li></ol><table style=\"min-width: 125px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Paramètre / parameter</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Norme</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Valeur/value</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa /checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Temperature</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">21±3°C</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Humidité /humidity</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">55±10%</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Pression</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">0±5 Pa</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"4\"><li><p style=\"text-align: left\">Effectuer le calibrage interne de la balance /start the scale calibration</p></li></ol><table style=\"min-width: 50px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa/checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"5\"><li><p style=\"text-align: left\">Introduire 1.3 kg d\'EP/introduce 1.3 kg PW</p></li></ol><p style=\"text-align: left\">Joindre l’étiquette de pesée /attach the weighing label</p><ol start=\"6\"><li><p style=\"text-align: left\">A la fin de la préparation, introduire la solution dans le réservoir du granulateur /at the end of preparation introduce the solution in the granulator container</p></li></ol><table style=\"min-width: 50px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa/checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"7\"><li><p style=\"text-align: left\">Vérifier la buse de pulvérisation et régler le débit de pulvérisation /check the spraying nozzel and set the sparying flow</p></li></ol><table style=\"min-width: 125px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Paramètre/parame ter</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Consigne/set</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Valeur/value</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Debit de pulvérisation</p><p style=\"text-align: left\">/Spraying flow</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Norme 160 -180 g</p><p style=\"text-align: left\">/min</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Type de buse</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Norme 8SS</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><p style=\"text-align: left\">Date et heure fin ending hour and date</p><p style=\"text-align: left\">Visa et date superviseur/ signature and date supervisor</p><p style=\"text-align: left\">Joindre le vide de ligne et l\'étiquette de nettoyage du becher, , balance préparation de la solution granulation et l\'étiquette statut local/attach cleaning label of beaker, , granulation solution preparation scale, granulation preparation room</p><h1 style=\"text-align: left\">MELANGE, GRANULATION, SECHAGE CALIBRAGE /DRY BLENDING, GRANULATION, DRYING MILLING FRACTION 2</h1><p style=\"text-align: left\">Equipement</p><table style=\"min-width: 75px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Désignation équipement/equipment designation</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Code /code</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Dernière date de qualification/étalonnage / last calibration and qualification date</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">granulateur/ granulator</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">EQ HP EFH 01</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Bin de déchargement /discharge bin</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">EQ HP MTB</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Dessicateur halogène/halogen moisture analyser</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">EQ HP ELQ 04</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><p style=\"text-align: left\">Date et heure début starting date and hour</p><h1 style=\"text-align: left\">15. 1. OPERATIONS PRELIMINIARES /PRELIMINARY OPERATIONS</h1><ol><li><p style=\"text-align: left\">Vérifier le vide de ligne du local granulation et du mélangeur granulateur /check the line clearance of the granulation room and the granulator</p></li></ol><table style=\"min-width: 50px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa/checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"2\"><li><p style=\"text-align: left\">Vérifier la conformité des paramètres de l\'environnement /check the conformity of environnement parameter</p></li></ol><table style=\"min-width: 125px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Norme</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Valeur lue/value</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa/checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Temperature</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">21±3°C</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Humidité /humidity</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">55±10%</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Pression</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">10±5 Pa</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"3\"><li><p style=\"text-align: left\">Installer les 2 filtres casse vide et système échantillonage indiquer leurs numéros de serie/ Install the 2 filters , vacuum break and sampling system indicate their serial numbers</p></li><li><p style=\"text-align: left\">Vérifier l’intégrité du calibreur / check the mill integrity</p></li></ol><table style=\"min-width: 50px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa/checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"5\"><li><p style=\"text-align: left\">Effectuer la connexion de la bin de chargement à la vanne active du granulateur selon l\'instruction en vigueur /start the conection of the loading bin to the active valve of the granulator according SOP</p></li></ol><table style=\"min-width: 50px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa/checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"6\"><li><p style=\"text-align: left\">Entamer le cycle de nettoyage de la twin valve selon l\'instruction en vigueur/start the cleaning cycle of the twin valve according SOP</p></li></ol><table style=\"min-width: 50px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa/checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"7\"><li><p style=\"text-align: left\">Vérifier le nettoyage de la bin/check the bin cleaning</p></li></ol><table style=\"min-width: 100px\"><colgroup><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Code bin /bin code</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Poids bin vide /weight empty bin</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa</p><p style=\"text-align: left\">/done by date and signature</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa/checked by date and signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><p style=\"text-align: left\">Coller étiquette de pesée signée/attach weighing label</p><ol start=\"8\"><li><p style=\"text-align: left\">Effectuer la connexion de la bin de déchargement à la vanne active de déchargement du granulateur</p></li></ol><p style=\"text-align: left\">/carry out the connexion of the unloading bin to th