t\">Code /code</p></th><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><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Désignation équipement/equipment designation</p></th><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><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Dernière date de qualification/étalonnage /last calibration and qualification date</p></th><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><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\">Machine à compression</p><p style=\"text-align: left\">/tabletting machine</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">EQ HP EFH 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\">Détécteur de metaux /metal detector</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">EQ HP EFH 04 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\">T 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 du local de compression et le vide de ligne de la machine à compression)./check the line clearance of tableting machine 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 e t 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 le vide de ligne du dépoussiéreur /check the line clearance of the deduster</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 e t 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 environment 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 /presssure</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=\"4\"><li><p style=\"text-align: left\"><span data-question=\"6\">Relever le poids de la TBIN vide /indicate the empty T BIN weight</span></p></li></ol><table data-table-form-id=\"316\" data-question-id=\"337\" 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\">Code T bin</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Poids T bin vide/empty T bin weight</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</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></tr></tbody></table><ol start=\"5\"><li><p style=\"text-align: left\">Procéder à la connexion de la T BIN à la vanne active de déchargement de la machine , entamer le cycle de nettoyage/carry out the T BIN connection to the discharge active valve of the machine , start the cleaning cycle</p></li><li><p style=\"text-align: left\">A la fin du cycle ouvrir la vanne passive de laT bin /at the end of the cycle open the Tbin 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><p style=\"text-align: left\">Procéder à la connexion de la bin contenant le mélange à la vanne active de chargement de la machine à compression selon l\'instruction en vigueur/Connect the bin containing the blend to the active loading valve of the compression machine according to SOP</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=\"8\"><li><p style=\"text-align: left\">entamer le cycle de nettoyage avant connexion/start cleaning cycle before connection</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\">à la fin du cycle ouvrir la vanne et charger la poudre /at the end of the cycle open the valve and load the powder</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 e t 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\"><span data-question=\"12\">Démarrer la machine à compression selon l\'instructionen vigueur, en faisant toutes les vérifications préliminaires /Start the compression machine according to the SOP , carry out all the preliminary checks</span></p><table data-table-form-id=\"4127\" data-question-id=\"4330\" data-header-orientation=\"vertical\" 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\">Paramètres</p></th><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Consignes /set</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Valeur /value</p></td></tr><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Cadence machine /machine speed</p></th><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">17 280-24 000/h</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Format utilisé/used format</p></th><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Poinçons rond biconvexe</p><p style=\"text-align: left\">/round biconvex punches</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Force de précompression</p><p style=\"text-align: left\">/precompression force</p></th><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">0.1 - 1KN</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Force de compression / main compression force</p></th><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">4.4 - 11 KN</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Dimension /Dimension</p></th><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">6 mm</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Épaisseur /thickness</p></th><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">3.0 -3.4 mm</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Masse moyenne/average weight</p></th><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">100 mg &nbsp;3%</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Came de remplissage /filling cam</p></th><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">10 mm</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table></li></ol><p style=\"text-align: left\"></p><h2 style=\"text-align: left\"><span data-question=\"13\">Test de calibrage détecteur de métaux début compression /calibration test metal detector</span></h2><table data-table-form-id=\"4128\" data-question-id=\"4331\" data-header-orientation=\"vertical\" 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\">Test de calibrage</p></th><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Détectée (Oui/non)</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Test conforme (Oui/non)</p></td></tr><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Pastille Ferreux /iron pellets</p></th><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><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"><strong>Pastille non Ferreux /non iron pellets</strong></p></th><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><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Pastille inox /stainless steel pellets</p></th><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><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Pastille blanc /white pellets</p></th><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\"></p><p style=\"text-align: left\">Pastille Ferreux /iron pellets</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\">Détectée/ detected</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Test conforme/test pass</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Oui/yes</p></td><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\">Non/no</p></td><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\">Pastille non Ferreux /non iron pellets</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\">Détectée/ detected</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Test conforme/test pass</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Oui/yes</p></td><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\">Non/no</p></td><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\">Pastille inox /stainless steel pellets</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\">Détectée/ detected</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Test conforme/test pass</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Oui/yes</p></td><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\">Non/no</p></td><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\">Pastille blanc /white pellets</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\">Détectée/ detected</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Test conforme/test pass</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Oui/yes</p></td><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\">Non/no</p></td><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\">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\"></p><p style=\"text-align: left\"><span data-subsection=\"24.2\">Fiche suivi compression / tabletting tracking sheet</span></p><p style=\"text-align: left\"></p><p style=\"text-align: left\"><span data-question=\"1\">Fiche suivi compression / tabletting tracking sheet</span></p><table data-table-form-id=\"4135\" data-question-id=\"4337\" 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\">Heure/hour</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Type d\'intervention/inter vention type</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par /done by</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><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><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><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><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><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><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><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><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><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><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><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\"><span data-question=\"2\">Signature /signature</span></p><p style=\"text-align: left\"></p><table data-table-form-id=\"4134\" data-question-id=\"4338\" data-header-orientation=\"horizontal\" data-table-form-status=\"created\" style=\"min-width: 25px\"><colgroup><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Signature /signature</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><h2 style=\"text-align: left\">24. 2. <span data-section=\"242\" data-subsection=\"24.2\">Controle des comprimés du réglage début de compression / setting tablet control beginning of tabletting</span></h2><p style=\"text-align: left\"></p><p style=\"text-align: left\"><span data-question=\"1\">Equipement</span></p><table data-table-form-id=\"779\" data-question-id=\"820\" data-header-orientation=\"vertical\" data-table-form-status=\"created\" 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\">Code /code</p></th><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><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Désignation équipement/equipment designation</p></th><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><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Dernière date de qualification/étalonnage</p><p style=\"text-align: left\">/ last calibration and qualification date</p></th><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><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><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Désignation équipement/equipment designation</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Code /code</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Dernière date de qualification/étalonnage / last calibration and qualification date</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 /scale IPQC</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">EQ HP DSM 03</p></td><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\">Testeur de durété /hardness tester</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">EQ HP ELQ 02</p></td><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\">Testeur de désintégration/ disintegration tester</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">EQ HP ELQ 01</p></td><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\">Testeur de friabilité friability tester</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">EQ HP ELQ 03</p></td><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\">Isolateur IPQC /IPC isolator</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">EQ HP ECE 07</p></td><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\"><span data-question=\"2\">Date et heure début/starting date and hour</span></p><table data-table-form-id=\"780\" data-question-id=\"821\" data-header-orientation=\"horizontal\" data-table-form-status=\"created\" style=\"min-width: 25px\"><colgroup><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Date et heure début/starting date and hour</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><p style=\"text-align: left\"><span data-question=\"3\">Après le chargement de la poudre, effectuer 2 tours de tourelle et prélever les comprimés de réglage pour effectuer les contrôles décrits ci-dessous Tous les tests doivent être conformes En cas de non-conformité de l’un des tests procéder au réglage, effectuer 2 tours de tourelle et reprendre tous les essais qui doivent être conformes avant la compression / After loading the powder, carry out 2 turns of the turret and take the adjustment tablets to carry out the controls described below All tests must comply In case of non- conformity of one of the tests proceed to the adjustment, carry out 2 turns of the turret and repeat all the tests which must be in conformity before compression</span></p><table data-table-form-id=\"781\" data-question-id=\"822\" 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\">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><h2 style=\"text-align: left\">24. 2. 1. <span data-subsection=\"242.1\">Contrôle de la masse moyenne -uniformité de masse/average weight /mass uniformity</span></h2><ol><li><p style=\"text-align: left\"><span data-question=\"1\">Effectuer un calibrage interne de la balance /carry out internal calibration of the scale</span></p></li></ol><table data-table-form-id=\"782\" data-question-id=\"823\" 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\">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\">Prélever 20 comprimés /take a sample of 20 tablet</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\">La masse moyenne doit être de /the average weight must be 100 mg ±3% masse/mass min : 97 mg et masse/mass max : 103 mg</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=\"4\"><li><p style=\"text-align: left\">Relever la masse individuelle de chaque comprimé/indicate the individual weight of each tablet</p></li><li><p style=\"text-align: left\"><span data-question=\"5\">La masse individuelle de chaque comprimé ne doit pas s\'écarter de la masse moyenne de + de 7.5%/the individual mass of each tablet must not deviate from the average mass by more than 7.5%. Remplir le tableau ci dessous /fill in the table below</span></p></li></ol><table data-table-form-id=\"787\" data-question-id=\"829\" data-header-orientation=\"vertical\" data-table-form-status=\"created\" style=\"min-width: 792px\"><colgroup><col style=\"width: 88px\"><col style=\"min-width: 25px\"><col style=\"width: 50px\"><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\"><col style=\"width: 48px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"width: 48px\"><col style=\"width: 41px\"><col style=\"width: 42px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"><col style=\"width: 50px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\" colwidth=\"88\"><p style=\"text-align: left\">Numéro du comprimé/tablet number</p></th><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Comp/tablet 1</p></td><td colspan=\"1\" rowspan=\"1\" colwidth=\"50\"><p style=\"text-align: left\">Comp/tablet 2</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Comp/tablet 3</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Comp/tablet 4</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Comp/tablet 5</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Comp/tablet 6</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Comp/tablet 7</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Comp/tablet 8</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Comp/tablet 9</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Comp/tablet 10</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Comp/tablet 11</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Comp/tablet 12</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Comp/tablet 13</p></td><td colspan=\"1\" rowspan=\"1\" colwidth=\"48\"><p style=\"text-align: left\">Comp/tablet 14</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Comp/tablet 15</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Comp/tablet 16</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Comp/tablet 17</p></td><td colspan=\"1\" rowspan=\"1\" colwidth=\"48\"><p style=\"text-align: left\">Comp/tablet 18</p></td><td colspan=\"1\" rowspan=\"1\" colwidth=\"41\"><p style=\"text-align: left\">Comp/tablet 19</p></td><td colspan=\"1\" rowspan=\"1\" colwidth=\"42\"><p style=\"text-align: left\">Comp/tablet 20</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Masse min 97 mg</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Masse max 103 mg</p></td><td colspan=\"1\" rowspan=\"1\" colwidth=\"50\"><p style=\"text-align: left\">Moyenne 100 mg±3%</p></td></tr><tr><th colspan=\"1\" rowspan=\"1\" colwidth=\"88\"><p style=\"text-align: left\">Réglage /setting 1</p></th><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\" colwidth=\"50\"><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><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><td colspan=\"1\" rowspan=\"1\" colwidth=\"48\"><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\" colwidth=\"48\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\" colwidth=\"41\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\" colwidth=\"42\"><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\" colwidth=\"50\"><p style=\"text-align: left\"></p></td></tr><tr><th colspan=\"1\" rowspan=\"1\" colwidth=\"88\"><p style=\"text-align: left\">Réglage /setting 2</p></th><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\" colwidth=\"50\"><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><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><td colspan=\"1\" rowspan=\"1\" colwidth=\"48\"><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\" colwidth=\"48\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\" colwidth=\"41\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\" colwidth=\"42\"><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\" colwidth=\"50\"><p style=\"text-align: left\"></p></td></tr><tr><th colspan=\"1\" rowspan=\"1\" colwidth=\"88\"><p style=\"text-align: left\">Réglage /setting 1</p></th><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\" colwidth=\"50\"><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><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><td colspan=\"1\" rowspan=\"1\" colwidth=\"48\"><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\" colwidth=\"48\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\" colwidth=\"41\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\" colwidth=\"42\"><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\" colwidth=\"50\"><p style=\"text-align: left\"></p></td></tr></tbody></table><p style=\"text-align: left\"></p><p style=\"text-align: left\"></p><p style=\"text-align: left\"></p><p style=\"text-align: left\"><span data-question=\"6\">Remplir le tableau ci dessous /fill in the table below</span></p><table data-table-form-id=\"788\" data-question-id=\"830\" 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\"></p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Numéro du comprimé/tablet number</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Réglage /setting 1</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Réglage /setting 2</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Réglage /setting 3</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\">Comp/tablet 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\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Comp/tablet 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><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Comp/tablet 3</p></td><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\">Comp/tablet 4</p></td><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\">Comp/tablet 5</p></td><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\">Comp/tablet 6</p></td><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\">Comp/tablet 7</p></td><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\">Comp/tablet 8</p></td><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\">Comp/tablet 9</p></td><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\">Comp/tablet 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\">Comp/tablet 11</p></td><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\">Comp/tablet 12</p></td><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\">Comp/tablet 13</p></td><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\">Comp/tablet 14</p></td><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\">Comp/tablet 15</p></td><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\">Comp/tablet 16</p></td><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\">Comp/tablet 17</p></td><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\">Comp/tablet 18</p></td><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\">Comp/tablet 19</p></td><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\">Comp/tablet 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><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Masse min 97 mg</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Masse 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\">Masse max 103 mg</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Masse max</p></td><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\">Moyenne 100 mg±3%</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Masse Moyenne</p></td><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\"><span data-question=\"7\">Fait par/Vérifié par</span></p><table data-table-form-id=\"789\" data-question-id=\"831\" 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\">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><h2 style=\"text-align: left\">24. 2. 2. <span data-subsection=\"242.2\">Contrôle de la dureté /hardness control</span></h2><p style=\"text-align: left\"><span data-question=\"1\">Prélever 10 comprimés début -milieu -fin compression et remplir le tableau ci dessous /take a sample of 10 tablet beginning -middle-end tabletting and fill in the table below</span></p><table data-table-form-id=\"790\" data-question-id=\"832\" 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\">Norme : 40N-100N</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Réglage/ setting 1</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Réglage setting 2</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Réglage/ setting 3</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Comp/tablet 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\">Comp/tablet 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><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Comp/tablet 3</p></td><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\">Comp/tablet 4</p></td><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\">Comp/tablet 5</p></td><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\">Comp/tablet 6</p></td><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\">Comp/tablet 7</p></td><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\">Comp/tablet 8</p></td><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\">Comp/tablet 9</p></td><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\">Comp/tablet 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></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><h2 style=\"text-align: left\">24. 2. 3. <span data-subsection=\"242.3\">Controle de l\'épaisseur /thickness control</span></h2><p style=\"text-align: left\"><span data-question=\"1\">Prélever 8 comprimés début -milieu -fin compression et remplir le tableau ci dessous /take a sample of 8 tablet beginning -middle-end tabletting and fill in the table below</span></p><table data-table-form-id=\"792\" data-question-id=\"834\" 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\">Norme : 3.0 mm-3.4 mm</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Réglage/ setting 1</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Réglage setting 2</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Réglage/ setting 3</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Comp/tablet 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\">Comp/tablet 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><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Comp/tablet 3</p></td><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\">Comp/tablet 4</p></td><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\">Comp/tablet 5</p></td><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\">Comp/tablet 6</p></td><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\">Comp/tablet 7</p></td><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\">Comp/tablet 8</p></td><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><h2 style=\"text-align: left\">24. 2. 4. <span data-subsection=\"242.4\">Contrôle de la friabilité /friability control</span></h2><p style=\"text-align: left\"><span data-question=\"1\">Prélever 65 comprimés., effectuer la pesée de l\'échantillon et placer les comprimés dans le tambour. Procédez à 100 rotations, puis sortir les comprimés du tambourr, éliminez les poussières libres peser à nouveau exactement. /Take 65 tablets., weigh the sample and place the tablets in the drum. Make 100 rotations, then take the tablets out of the drum, eliminate the free dust weigh exactly again</span></p><table data-table-form-id=\"794\" data-question-id=\"836\" 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\">Norme : % de perte/loss</p><p style=\"text-align: left\">&lt;1%</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Réglage /setting 1</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Réglage /setting 2</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Réglage /setting 3</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Masse de 65 comprimés avant test /Mass of 65 tablets before testing</p></td><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\">Masse de 65 comprimés après test/Mass of 65 tablets after testing</p></td><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\">% de perte /loss</p></td><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><h2 style=\"text-align: left\">24. 2. 5. <span data-subsection=\"242.5\">Contrôle de la désintégration/disintégration control</span></h2><p style=\"text-align: left\"><span data-question=\"1\">Prélever 6 comprimés, placer 1 unité dans chacun des 6 tubes de l\'appareil de désintégration, puis ajoutez un disque. Faire fonctionner l’appareil en utilisant, comme liquide d’immersion l’eau purifié maintenu à 37 ± 2 ° C. Toutes les unités sont complètement désagégées avec absence de trace au niveau des grilles</span></p><p style=\"text-align: left\"><span data-question=\"1\">/take 6 tablets, place 1 unit in each of the 6 tubes of the disintegration tester then add a disc start operation using, as immersion liquid, the purified water maintained at 37 ± 2 ° C. note the time after which. All units are completely disintegrated with no trace at the grids</span></p><p style=\"text-align: left\"></p><table data-table-form-id=\"796\" data-question-id=\"838\" 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\">Norme : % de perte/loss</p><p style=\"text-align: left\">&lt;1%</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Réglage /setting 1</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Réglage /setting 2</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Réglage /setting 3</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Comp/tablet 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\">Comp/tablet 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><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Comp/tablet 3</p></td><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\">Comp/tablet 4</p></td><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\">Comp/tablet 5</p></td><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\">Comp/tablet 6</p></td><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\">Temps maximal de désintégration</p><p style=\"text-align: left\">/disintegration maximum time</p></td><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><h2 style=\"text-align: left\">24. 2. 6. <span data-subsection=\"242.6\">Contrôle de l\'aspect -dimensions /appeararence-dimension contrôle :</span></h2><p style=\"text-align: left\"></p><p style=\"text-align: left\">Prélever 8 comprimés à chaque réglage et -Vérifier l’aspect :absence décalottage (séparation partielle ou complète des couronnes supérieure ou inférieure d\'un comprimé du corps principal) de stratification (séparation d\'un comprimé en deux ou plusieurs couches distinctes) de Collage (l’adhésion d’une partie du comprimé au poinçons) de marbrage (Distribution de couleur inégale avec des zones claires ou sombres), pas de comprimé cassé ou ébréché / -vérifier les dimensions au moyen du testeur de durété norme : comprimé rond diamètre 6 Take 8 tablets at each setting and check the appearance: absence of capping (partial or complete separation of the upper or lower crowns of a tablet from the main body) of lamination (separation of a tablet into two or more separate layers) of sticking ( adhesion of part of the tablet to the punches) of motlling (Uneven color distribution with light or dark areas), no broken or chipped tablet -check the dimensions using the standard hardness tester: round tablet, diameter 6</p><p style=\"text-align: left\"></p><p style=\"text-align: left\"><span data-question=\"1\">Prélever 8 comprimés à chaque réglage et vérifier l’aspect / Take 8 tablets at each setting and check the appearance</span></p><p style=\"text-align: left\"></p><table data-table-form-id=\"1045\" data-question-id=\"1084\" data-header-orientation=\"vertical\" 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\">Absence décalottage</p></th><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Séparation partielle ou complète des couronnes supérieure ou inférieure d\'un comprimé du corps principal</p></td></tr><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Stratification</p></th><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Séparation d\'un comprimé en deux ou plusieurs couches distinctes</p></td></tr><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Collage</p></th><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">L’adhésion d’une partie du comprimé au poinçons</p></td></tr><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Marbrage</p></th><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Distribution de couleur inégale avec des zones claires ou sombres</p></td></tr><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Pas de comprimé cassé ou ébréché</p></th><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">-</p></td></tr><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa /checked by date and signature</p></th><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><p style=\"text-align: left\"><span data-question=\"2\">Vérifier les dimensions au moyen du testeur de durété norme : comprimé rond diamètre 6</span></p><table data-table-form-id=\"801\" data-question-id=\"843\" 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\">Norme comprimé rond diamètre 6mm biconvexe de couleur blanche / White, round 6 mm, biconvex tablet</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Réglage /setting 1</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Réglage /setting 2</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Réglage /setting 3</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Comp/tablet 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\">Comp/tablet 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><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Comp/tablet 3</p></td><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\">Comp/tablet 4</p></td><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\">Comp/tablet 5</p></td><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\">Comp/tablet 6</p></td><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\">Comp/tablet 7</p></td><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\">Comp/tablet 8</p></td><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\"></p><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\">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 de l\'équipement et l\'étiquette statut local/attach the equipment line clearance label and cleaning label of room</p><h1 style=\"text-align: left\">24. 3. <span data-section=\"243\">CONTROLE EN COURS DE LA COMPRESSION / TABLETTING IN PROCESS CONTROL</span></h1><p style=\"text-align: left\"><span data-question=\"1\">Equipement</span></p><table data-table-form-id=\"805\" data-question-id=\"847\" data-header-orientation=\"vertical\" data-table-form-status=\"created\" 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\">Code /code</p></th><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><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Désignation équipement/equipment designation</p></th><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><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Dernière date de qualification/étalonnage / last calibration and qualification date</p></th><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><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\">Isolateur IPQC /IPC isolator</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">EQ HP ECE 07</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 /scale IPQC</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">EQ HP DSM 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\">Testeur de durété /hardness tester</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">EQ HP ELQ 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\">Testeur de désintégration/ disintegration tester</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">EQ HP ELQ 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\">Testeur de friabilité friability tester</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">EQ HP ELQ 03</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><p style=\"text-align: left\"><span data-question=\"2\">Date et heure début/starting date and hour</span></p><table data-table-form-id=\"806\" data-question-id=\"848\" data-header-orientation=\"horizontal\" data-table-form-status=\"created\" style=\"min-width: 25px\"><colgroup><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Date et heure début/starting date and hour</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><h2 style=\"text-align: left\">24. 3. 1. <span data-subsection=\"243.1\">Contrôle de la masse moyenne -uniformité de masse/average weight /mass uniformity</span></h2><ol><li><p style=\"text-align: left\"><span data-question=\"1\">Effectuer un calibrage interne de la balance /carry out internal calibration of the scale</span></p></li></ol><table data-table-form-id=\"807\" data-question-id=\"849\" 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\">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\">Prélever 20 comprimés /take a sample of 20 tablet</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\">La masse moyenne doit être de /the average weight must be 100 mg ±3% masse/mass min : 97 mg et masse/mass max : 103 mg</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=\"4\"><li><p style=\"text-align: left\">Relever la masse individuelle de chaque comprimé/indicate the individual weight of each tablet</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\">La masse individuelle de chaque comprimé ne doit pas s\'écarter de la masse moyenne de + de 7.5% /the individual mass of each tablet must not deviate from the average mass by more than 7.5% . Remplir le tableau ci dessous /fill in the table below:</p></li></ol><table style=\"min-width: 200px\"><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\"></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\">Numéro comprimé</p><p style=\"text-align: left\">/tablet number</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Temps</p><p style=\"text-align: left\">/time:T0</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Temps</p><p style=\"text-align: left\">/time: 1h</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Temps</p><p style=\"text-align: left\">/time : 2h</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Temps</p><p style=\"text-align: left\">/time: 3h</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Temps</p><p style=\"text-align: left\">/time : 4h</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Temps</p><p style=\"text-align: left\">/time : 5h</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\">Comp/ tablet 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><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\">Comp/ tablet 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><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\">Comp/ tablet 3</p></td><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><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Comp/ tablet 4</p></td><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><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Comp/ tablet 5</p></td><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><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Comp/ tablet 6</p></td><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><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Comp/ tablet 7</p></td><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><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Comp/ tablet 8</p></td><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><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Comp/ tablet 9</p></td><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><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Comp/ tablet 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><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\">Comp/ tablet 11</p></td><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><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Comp/ tablet 12</p></td><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><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Comp/ tablet 13</p></td><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><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Comp/ tablet 14</p></td><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><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Comp/ tablet 15</p></td><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><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Comp/ tablet 16</p></td><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><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Comp/ tablet 17</p></td><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\">Fait par/Vérifié par</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 91 / 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=\"6\"><li><p style=\"text-align: left\">Remplir le tableau ci dessous /fill in the table below</p></li></ol><table style=\"min-width: 200px\"><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\"></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\">Temps</p><p style=\"text-align: left\">/time: 6h</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Temps</p><p style=\"text-align: left\">/time: 7h</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Temps</p><p style=\"text-align: left\">/time : 8h</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Temps</p><p style=\"text-align: left\">/time: 9h</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Temps</p><p style=\"text-align: left\">/time : 10h</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Temps</p><p style=\"text-align: left\">/time : 11h</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Masse</p><p style=\"text-align: left\">/mass min</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">97 mg</p></td><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><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Masse/ mass max</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\"></p></td><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\">Masse moye</p><p style=\"text-align: left\">/avera ge mass</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">100 mg±3</p><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><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=\"7\"><li><p style=\"text-align: left\">Joindre l\'étiquette d\'uniformité de masse correspondante à chaque prélèvement /attach the mass uniformity label of each sample</p></li></ol><h2 style=\"text-align: left\">3. 2. <span data-subsection=\"243.2\">Contrôle en cours de la dureté /hardness control</span></h2><p style=\"text-align: left\"><span data-question=\"1\">Prélever 10 comprimés début -milieu -fin compression et remplir le tableau ci dessous /take a sample of 10 tablet beginning -middle-end tabletting and fill in the table below</span></p><table data-table-form-id=\"814\" data-question-id=\"856\" 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\">Norme : 40N-100N</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/ midlle</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\">Comp/tablet 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\">Comp/tablet 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><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Comp/tablet 3</p></td><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\">Comp/tablet 4</p></td><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\">Comp/tablet 5</p></td><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\">Comp/tablet 6</p></td><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\">Comp/tablet 7</p></td><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\">Comp/tablet 8</p></td><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\">Comp/tablet 9</p></td><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\">Comp/tablet 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></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><h2 style=\"text-align: left\">24. 3. 3. <span data-subsection=\"243.3\">Controle en cours de l\'épaisseur /thickness in process control</span></h2><p style=\"text-align: left\"></p><p style=\"text-align: left\"><span data-question=\"1\">Prélever 8 comprimés début -milieu -fin compression et remplir le tableau ci dessous /take a sample of 8 tablet beginning -middle-end tabletting and fill in the table below</span></p><p style=\"text-align: left\"></p><table data-table-form-id=\"816\" data-question-id=\"858\" 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\">Norme : 3.0 mm-3.4 mm</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Réglage/ setting 1</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Réglage setting 2</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Réglage/ setting 3</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Comp/tablet 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\">Comp/tablet 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><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Comp/tablet 3</p></td><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\">Comp/tablet 4</p></td><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\">Comp/tablet 5</p></td><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\">Comp/tablet 6</p></td><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\">Comp/tablet 7</p></td><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\">Comp/tablet 8</p></td><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><h2 style=\"text-align: left\">24. 3. 4. <span data-subsection=\"243.4\">Contrôle en cours de la friabilité /friability in process control</span></h2><p style=\"text-align: left\"><span data-question=\"1\">Prélever 65 comprimés., effectuer la pesée de l\'échantillon et placer les comprimés dans le tambour. Procédez à 100 rotations, puis sortir les comprimés du tambourr, éliminez les poussières libres peser à nouveau exactement. /Take 65 tablets., weigh the sample and place the tablets in the drum. Make 100 rotations, then take the tablets out of the drum, eliminate the free dust weigh exactly again</span></p><table data-table-form-id=\"817\" data-question-id=\"859\" 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\">Norme : % de perte/loss</p><p style=\"text-align: left\">&lt;1%</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Début /</p><p style=\"text-align: left\">beginning</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Milieu</p><p style=\"text-align: left\">/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\">Masse de 65 comprimés avant test /Mass of 65 tablets before testing</p></td><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\">Masse de 65 comprimés après test/Mass of 65 tablets after testing</p></td><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\">% de perte /loss</p></td><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><h2 style=\"text-align: left\">24. 3. 5. <span data-subsection=\"243.5\">Contrôle en cours de la désintégration/disintégration in process control</span></h2><p style=\"text-align: left\"><span data-question=\"1\">Prélever 6 comprimés, placer 1 unité dans chacun des 6 tubes de l\'appareil de désintégration, puis ajoutez un disque. Faire fonctionner l’appareil en utilisant, comme liquide d’immersion l’eau purifié maintenu à37 ± 2 ° C. Toutes les unités sont complètement désagégées avec absence de trace au niveau des grilles</span></p><p style=\"text-align: left\"><span data-question=\"1\">/take 6 tablets, place 1 unit in each of the 6 tubes of the disintegration tester then add a disc start operation using, as immersion liquid, the purified water maintained at 37 ± 2 ° C. note the time after which. All units are completely disintegrated with no trace at the grids</span></p><table data-table-form-id=\"818\" data-question-id=\"860\" 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\">Norme : &lt;=15 min</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Début /</p><p style=\"text-align: left\">beginning</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Milieu</p><p style=\"text-align: left\">/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\">Comp/tablet 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><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Comp/tablet 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><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Comp/tablet 3</p></td><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\">Comp/tablet 4</p></td><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\">Comp/tablet 5</p></td><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\">Comp/tablet 6</p></td><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\">Temps maximalde désintégration</p><p style=\"text-align: left\">/disintegration maximum time</p></td><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><h2 style=\"text-align: left\">24. 3. 6. <span data-subsection=\"243.6\">Contrôle en cours de l\'aspect /appeararence in process contrôle</span></h2><p style=\"text-align: left\"></p><p style=\"text-align: left\"><span data-question=\"1\">Prélever 8 comprimés début-milieu-fin -Vérifier l’aspect</span></p><table data-table-form-id=\"819\" data-question-id=\"862\" data-header-orientation=\"horizontal\" data-table-form-status=\"created\" style=\"min-width: 175px\"><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\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Absence décalottage</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Stratification</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Collage</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Marbrage</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Pas de comprimé cassé ou ébréché</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\">Séparation partielle ou complète des couronnes supérieure ou inférieure d\'un comprimé du corps principal</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Séparation d\'un comprimé en deux ou plusieurs couches distinctes</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">l’adhésion d’une partie du comprimé au poinçons</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Distribution de couleur inégale avec des zones claires ou sombres</p></td><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\"></p><p style=\"text-align: left\">absence décalottage (séparation partielle ou complète des couronnes supérieure ou inférieure d\'un comprimé du corps principal) de stratification (séparation d\'un comprimé en deux ou plusieurs couches distinctes) de Collage (l’adhésion d’une partie du comprimé au poinçon) de marbrage (Distribution de couleur inégale avec des zones claires ou sombres), pas de comprimé cassé ou ébréché /</p><p style=\"text-align: left\"></p><p style=\"text-align: left\"><span data-question=\"2\">Vérifier les dimensions au moyen du testeur de durété norme : comprimé rond diamètre 6</span></p><p style=\"text-align: left\"></p><p style=\"text-align: left\">Take 8 tablets at each setting and check the appearance: absence of capping (partial or complete separation of the upper or lower crowns of a tablet from the main body) of lamination (separation of a tablet into two or more separate layers) of sticking ( adhesion of part of the tablet to the punches) of motlling (Uneven color distribution with light or dark areas), no broken or chipped tablet -check the dimensions using the standard hardness tester: round tablet, diameter 6</p><table data-table-form-id=\"820\" data-question-id=\"863\" 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\">Norme comprimé rond diamètre 6mm biconvexe de couleur blanche / White, round 6 mm, biconvex tablet</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Début / beginning</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\">Comp/tablet 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\">Comp/tablet 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><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Comp/tablet 3</p></td><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\">Comp/tablet 4</p></td><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\">Comp/tablet 5</p></td><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\">Comp/tablet 6</p></td><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\">Comp/tablet 7</p></td><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\">Comp/tablet 8</p></td><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\"><span data-question=\"3\">A la fin de la compression procéder à la déconnexion de la bin de chargement et la bin de déchargement Effectuer le cycle de nettoyage avant et après déconnexion Entamer le cycle de nettoyage des accessoires et de la machine /At the end of the compression proceed to the disconnection of the loading bin and the unloading bin Carry out the cleaning cycle before and after disconnection Start the cleaning cycle of the accessories and the machine</span></p><table data-table-form-id=\"821\" data-question-id=\"864\" 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\">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 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 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\"><span data-section=\"25\">RECONCILIATION DE LA COMPRESSION /TABLETTING YIELD CALCULATION</span></h1><p style=\"text-align: left\"><span data-question=\"1\">Equipements</span></p><p style=\"text-align: left\"></p><table data-table-form-id=\"330\" data-question-id=\"354\" data-header-orientation=\"vertical\" 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\">Code /code</p></th><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Désignation équipement/equipment designation</p></th><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Dernière date de qualification/étalonnage /last calibration and qualification date</p></th><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><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 reconciliation / reconciliation scale</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">EQ HP DSM 12</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\">A partir des relevés réalisés en cours de compression, calculer la masse moyenne d\'un comprimé /from the weight result taken during compression , calculate the average weigt of 1 tablet</p></li></ol><p style=\"text-align: left\"></p><ol><li><p style=\"text-align: left\">Relever le poids de la T bin remplie/Indicate the filled T bin weight</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 T bin /T bin code</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Poids T bin remplie / filled T bin weight</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</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></tr></tbody></table><p style=\"text-align: left\"><span data-question=\"5\">Calculer le rendement /calculate the yied</span></p><table data-table-form-id=\"4140\" data-question-id=\"4352\" data-header-orientation=\"vertical\" 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\">Paramètres</p></th><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Masse totale /total weight (g)</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Nombre de comprimé /tablet number</p></td></tr><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Quantité théorique / theoretical quantity</p></th><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><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Quantité réelle /real quantity</p></th><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><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Perte réglage /setting loss</p></th><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><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Perte contrôle en cours /In process control loss</p></th><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><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Rejet detecteur de metaux/metal detector reject</p></th><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><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Perte sabot alimentation /feeder loss</p></th><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><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Perte système aspiration machine /extraction system loss</p></th><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><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Quantité prelevée /sampled quantity</p></th><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><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Rendement /yield</p></th><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\"><span data-question=\"6\">Rendement = quantité réelle /quantité theorique *100 / Yield = real quantity /theoritical quantity *100</span></p><p style=\"text-align: left\"><span data-question=\"7\">Si le rendement est inférieur à 94% faire une deviation / If the yield is lower than 94% record a deviation</span></p><p style=\"text-align: left\"></p><p style=\"text-align: left\"><span data-question=\"7\">Fait par/Vérifié par</span></p><table data-table-form-id=\"337\" data-question-id=\"362\" 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\">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\">coller ici étiquette de pesée /attach weighing label</p><h2 style=\"text-align: left\"></h2><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\"><span data-question=\"11\">Joindre le vide de ligne de l\'étiquette statut local/attach the equipment line clearance label and cleaning label of room</span></p><h1 style=\"text-align: left\">PESÉE DE L\'EXCIPIENT DE PELLICULAGE /WEIGHING FILM COATING EXCIPIENT</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\">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\">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=\"5\"><li><p style=\"text-align: left\">Vérifier le nettoyage des accessoires de pesée/check 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=\"6\"><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=\"7\"><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: 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 98 / 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=\"8\"><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/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=\"9\"><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\">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\"><span data-section=\"27\">PREPARATION DE LA SUSPENSION DE PELLICULAGE /COATING SUSPENSION PREPARATION</span></h1><p style=\"text-align: left\"><span data-question=\"1\">Equipements</span></p><p style=\"text-align: left\"></p><table data-table-form-id=\"340\" data-question-id=\"367\" data-header-orientation=\"vertical\" 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\">Code /code</p></th><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><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Désignation équipement/equipment designation</p></th><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><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Dernière date de qualification/étalonnage /last calibration and qualification date</p></th><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><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 granulation solution</p><p style=\"text-align: left\">/granulation solution 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><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Cuve de préparation / preparation tank</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">EQ HP EFH 30</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><p style=\"text-align: left\"><span data-question=\"2\">Date et heure début/starting date and hour</span></p><table data-table-form-id=\"342\" data-question-id=\"370\" 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\">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\"></p><ol><li><p style=\"text-align: left\"><span data-question=\"3\">Vérifier le vide de ligne et le nettoyage de la balance de préparation de la solution de granulation et du becher de 5 litres /check the line clearance of granulation solution preparation scale and 5 liters beaker</span></p></li></ol><table data-table-form-id=\"343\" data-question-id=\"369\" 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\">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\"></p><ol start=\"2\"><li><p style=\"text-align: left\">Vérifier la conformité des paramètres de l\'environnement /check the conformity of environment parameter</p></li></ol><p style=\"text-align: left\"></p><ol start=\"2\"><li><p style=\"text-align: left\"><span data-question=\"5\">Effectuer le calibrage interne de la balance /carry out scale calibration</span></p></li></ol><table data-table-form-id=\"344\" data-question-id=\"371\" 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\">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\"><span data-question=\"6\">Introduire 3000g d\'EP / introduce 3000 g PW</span></p></li></ol><table data-table-form-id=\"345\" data-question-id=\"372\" 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\">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\"><span data-question=\"7\">Faire dissoudre sous agitation /introduce under mixing Opadry II jaune (g)</span></p></li></ol><table data-table-form-id=\"346\" data-question-id=\"373\" 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\">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\"><span data-question=\"8\">Compléter QSP 4000 g en ajoutant l\'EP /complete QS 4000 g by adding PW</span></p></li></ol><table data-table-form-id=\"347\" data-question-id=\"374\" 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\">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\"></p><p style=\"text-align: left\"><span data-question=\"9\">Coller ici étiquette de pesée /attach weighing label</span></p><table data-table-form-id=\"348\" data-question-id=\"375\" 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\">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=\"10\">Faire fonctionner l\'agitation pendant start mixing during 15±5 min</span></p></li></ol><table data-table-form-id=\"349\" data-question-id=\"376\" 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\">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=\"8\"><li><p style=\"text-align: left\"><span data-question=\"11\">Vérifier la couleur et l\'homogénéité de la suspension de pelliculage (absence d\'agglomérat)./ Check the color and homogeneity of the film-coating suspension (no agglomerate).</span></p></li></ol><table data-table-form-id=\"4142\" data-question-id=\"4361\" data-header-orientation=\"vertical\" data-table-form-status=\"created\" style=\"min-width: 503px\"><colgroup><col style=\"width: 453px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\" colwidth=\"453\"><p style=\"text-align: left\">Paramètre/parameter</p></th><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></tr><tr><th colspan=\"1\" rowspan=\"1\" colwidth=\"453\"><p style=\"text-align: left\">Vitesse Agitation /mixing speed</p></th><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">150 ±20 rpm</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><th colspan=\"1\" rowspan=\"1\" colwidth=\"453\"><p style=\"text-align: left\">Heure début agitation /mixing starting hour</p></th><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">14-20 min</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><th colspan=\"1\" rowspan=\"1\" colwidth=\"453\"><p style=\"text-align: left\">Heure fin agitation / mixing ending hour</p></th><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">14-20 min</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><th colspan=\"1\" rowspan=\"1\" colwidth=\"453\"><p style=\"text-align: left\">Aspect /appearance (C/NC)</p></th><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Suspension homogène / Homogeneous suspension</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><p style=\"text-align: left\"><span data-question=\"12\">Fait par/Vérifié par</span></p><table data-table-form-id=\"351\" data-question-id=\"378\" 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\">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\"><span data-question=\"12\">A la fin de la préparation, transférer la préparation vers le local de pelliculage et procédér à la connexion de la pompe au conteneur de la préparation /At the end of the preparation, transfer the preparation to the coating room and connect the pump to the container of the preparation</span></p></li></ol><table data-table-form-id=\"352\" data-question-id=\"379\" 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\">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\"><span data-question=\"13\">Maintenir l\'agitation pendant le pelliculage /maintain the mixing during the film coating</span></p></li></ol><table data-table-form-id=\"353\" data-question-id=\"380\" 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\">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\"></p><p style=\"text-align: left\"><span data-question=\"14\">Date et heure fin ending hour and date</span></p><table data-table-form-id=\"4144\" data-question-id=\"4365\" data-header-orientation=\"horizontal\" data-table-form-status=\"created\" style=\"min-width: 25px\"><colgroup><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Date et heure fin ending hour and date</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><p style=\"text-align: left\"><span data-question=\"15\">Visa et date superviseur signature and date supervisor</span></p><table data-table-form-id=\"4145\" data-question-id=\"4366\" data-header-orientation=\"horizontal\" data-table-form-status=\"created\" style=\"min-width: 25px\"><colgroup><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Visa et date superviseur signature and date supervisor</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><p style=\"text-align: left\"></p><p style=\"text-align: left\"><span data-question=\"16\">Joindre le vide de ligne et l\'étiquette de nettoyage du becher ,agitateur , balance préparation solution de granulation et l\'étiquette statut local/attach cleaning label of beaker , mixer , granulation solution preparation scale, granulation preparation room</span></p><h1 style=\"text-align: left\"><span data-section=\"28\">PELLICULAGE /FILMCOATING</span></h1><p style=\"text-align: left\"><span data-question=\"1\">Equipement</span></p><table data-table-form-id=\"361\" data-question-id=\"387\" data-header-orientation=\"vertical\" 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\">Code /code</p></th><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><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Désignation équipement/equipment designation</p></th><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><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Dernière date de qualification/étalonnage / last calibration and qualification date</p></th><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><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\">Trurbine de pelliculage /coating pan</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">EQ HP EFH05</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\">Potence élévatrice/bin lift</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">EQ HP EMN 05</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\">28. 1. <span data-subsection=\"28.1\">OPERATIONS PRELIIMINAIRES/PRELIMINARY OPERATIONS</span></h1><ol><li><p style=\"text-align: left\"><span data-question=\"1\">Vérifier le vide de ligne du local et de la turbine de pelliculage, check the line clearance of the film coating machine and room</span></p></li></ol><table data-table-form-id=\"363\" data-question-id=\"389\" 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\">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\">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 environment parameter</p></li><li><p style=\"text-align: left\">Effectuer la connexion de la T bin contenant les comprimés à la twin valvede la turbine /Make the connection of the T bin containing the tablets to the twin valve of the turbine</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\">Entamer le cycle de nettoyage à la fin du cycle ouvrir la vanne et charger les comprimés /Start the cleaning, at the end of the cycle open the valve and load the tablet .</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 103 / 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=\"6\"><li><p style=\"text-align: left\">Vérifier le nettoyage et l\'identification du conteneur dédié pour la récupération des comprimés pelliculés/Check the cleaning and identification of film coated tablet dedicated 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 présence de la buse de pulvérisation du liquide de pelliculage et sa position/check the presence and the position of spraying nozzle</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\">28. 2. <span data-subsection=\"28.2\">PRECHAUFFAGE DU LIT DES COMPRIMES /PRE-WARM TABLET BED</span></h1><ol><li><p style=\"text-align: left\">Indiquer les paramètres suivants : /indicate the following parameter</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\"></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</p><p style=\"text-align: left\">début/starting hour</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">H fin/ending hour</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</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\">Temps /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><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><li><p style=\"text-align: left\"><span data-question=\"1\">Indiquer les paramètres suivants : /indicate the following parameter</span></p></li></ol><table data-table-form-id=\"371\" data-question-id=\"397\" data-header-orientation=\"vertical\" 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><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Paramètre /parameter</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></tr><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">H début/starting hour</p><p style=\"text-align: left\"></p></th><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><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">H fin/ending hour</p></th><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><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Temps /time</p></th><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></tr><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Température d\'air d\'entrée /inlet air temperature</p></th><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">55-75°C</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Température du lit des comprimés /tablet bed temperature</p></th><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">45°-52°C</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Débit d\'air /air flow</p></th><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">650-670 m3/h</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vitesse de rotation de la turbine</p><p style=\"text-align: left\">/pan speed</p></th><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">5 ± 2 rpm</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><p style=\"text-align: left\"><span data-question=\"2\">Fait par/Vérifié par</span></p><table data-table-form-id=\"372\" data-question-id=\"398\" 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\">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\"><span data-question=\"2\">Indiquer les paramètres suivants : /indicate the following parameter</span></p><table data-table-form-id=\"4146\" data-question-id=\"4368\" data-header-orientation=\"vertical\" 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\">Paramètre /parameter</p></th><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></tr><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">H début/starting hour</p><p style=\"text-align: left\"></p></th><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><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">H fin/ending hour</p></th><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><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Temps /time</p></th><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></tr><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Température d\'air d\'entrée /inlet air temperature</p></th><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">55-75°C</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Température du lit des comprimés /tablet bed temperature</p></th><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">45°-52°C</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Débit d\'air /air flow</p></th><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">650-670 m3/h</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vitesse de rotation de la turbine</p><p style=\"text-align: left\">/pan speed</p></th><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">5 ± 2 rpm</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><p style=\"text-align: left\"></p><p style=\"text-align: left\"><span data-question=\"2\">A la fin du préchauffage , ouvrir la vanne et charger les comprimés /at the end of pre-warm open the valve and load the tablet</span></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><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 104 / 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><h1 style=\"text-align: left\">28. 3. <span data-subsection=\"28.3\">PULVERISATION /SPARYING</span></h1><ol><li><p style=\"text-align: left\">Indiquer les paramètres suivants : /indicate the following parameter</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\"></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</p><p style=\"text-align: left\">début/starting hour</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">H fin/ending hour</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</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\">Temps /time</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">40-60 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><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><p style=\"text-align: left\"></p><p style=\"text-align: left\"><span data-question=\"1\">Indiquer les paramètres suivants : /indicate the following parameter</span></p><table data-table-form-id=\"4153\" data-question-id=\"4376\" data-header-orientation=\"vertical\" 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\">Paramètre /parameter</p></th><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></tr><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">H début/ starting hour</p></th><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><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">H fin/ ending hour</p></th><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><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Temps /time</p></th><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">40-60 min</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Température d\'air d\'entrée /inlet air temperature</p></th><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">55-75°C</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Température du lit des comprimés /tablet bed temperature</p></th><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">45°-50°C</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Débit d\'air /air flow</p></th><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">650-670 m3/h</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Dépression /depressure</p></th><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">-100 ±10 PA</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vitesse de rotation de la turbine</p><p style=\"text-align: left\">/pan speed</p></th><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">10 19 - rpm</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Débit de pulvérisation /spray rate</p></th><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">7 - 15 g/min</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Pression d\'aird\'atomisation</p><p style=\"text-align: left\">/atomizing air pressure</p></th><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">1-1.5 bar</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Pression du jet /jet pressure</p></th><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">1-2 bar</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Angle rotation buse / Nozzle rotation angle</p></th><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">30 °</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\">28. 4. <span data-subsection=\"28.4\">REFROIDISSEMENT /COOLING</span></h1><ol><li><p style=\"text-align: left\">Indiquer les paramètres suivants : /indicate the following parameter</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\">Paramètre</p><p style=\"text-align: left\">/parameter</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</p><p style=\"text-align: left\">début/starting hour</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">H fin/ending hour</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</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\">Temps /time</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">30 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><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol><li><p style=\"text-align: left\"><span data-question=\"1\">Indiquer les paramètres suivants : /indicate the following parameter</span></p></li></ol><table data-table-form-id=\"4154\" data-question-id=\"4377\" data-header-orientation=\"vertical\" 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\">Paramètre /parameter</p><p style=\"text-align: left\"></p></th><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></tr><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">H début/ starting hour</p></th><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><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">H fin/ ending hour</p></th><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><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Temps /time</p></th><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">30 min</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Température d\'air d\'entrée /inlet air temperature</p></th><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">0°C</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Température du lit des comprimés /tablet bed temperature</p></th><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">25 ±5°C</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Débit d\'air /air flow</p></th><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">620-670 m3/h</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Dépression /depressure</p></th><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">-95 -105 PA</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vitesse de rotation de la turbine</p><p style=\"text-align: left\">/pan speed</p></th><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">3 - 7 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><p style=\"text-align: left\"><span data-question=\"2\">Date et heure fin ending hour and date</span></p><table data-table-form-id=\"4156\" data-question-id=\"4378\" data-header-orientation=\"horizontal\" data-table-form-status=\"created\" style=\"min-width: 25px\"><colgroup><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Date et heure fin ending hour and date</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><p style=\"text-align: left\"><span data-question=\"3\">Visa et date superviseur signature and date supervisor</span> :</p><p style=\"text-align: left\"></p><p style=\"text-align: left\"><span data-question=\"4\">Joindre le vide de ligne de l\'équipement et l\'étiquette statut local/attach the equipment line clearance label and cleaning label of room</span></p><p style=\"text-align: left\"></p><p style=\"text-align: left\"><span data-subsection=\"30.5\">Fiche suivi pelliculage / film coating tracking sheet</span></p><p style=\"text-align: left\"></p><p style=\"text-align: left\"><span data-question=\"1\">Fiche suivi pelliculage / film coating tracking sheet</span></p><table data-table-form-id=\"4155\" data-question-id=\"4380\" 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\">Heure/hour</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Type d\'intervention/inter vention type</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par /done by</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><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><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><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><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><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><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><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><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><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><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><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\"></p><p style=\"text-align: left\"></p><p style=\"text-align: left\"></p><h1 style=\"text-align: left\">5. <span data-section=\"285\">CONTROLE EN COURS DU PELLICULAGE /FILM COATING IPC</span></h1><p style=\"text-align: left\"><span data-question=\"1\">Equipements</span></p><table data-table-form-id=\"831\" data-question-id=\"874\" data-header-orientation=\"vertical\" data-table-form-status=\"created\" style=\"min-width: 449px\"><colgroup><col style=\"width: 399px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\" colwidth=\"399\"><p style=\"text-align: left\">Code /code</p></th><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><th colspan=\"1\" rowspan=\"1\" colwidth=\"399\"><p style=\"text-align: left\">Désignation équipement/equipment designation</p></th><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><th colspan=\"1\" rowspan=\"1\" colwidth=\"399\"><p style=\"text-align: left\">Dernière date de qualification/étalonnage / last calibration and qualification date</p></th><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><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><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Désignation équipement/equipment designation</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Code /code</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Dernière date de qualification/étalonnage / last calibration and qualification date</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 IPQC</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">EQ HP DSM 03</p></td><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\">Isolateur IPQC</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">EQ HP ECE 07</p></td><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\">Testeur de durété /hardness tester</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">EQ HP ELQ 02</p></td><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><h2 style=\"text-align: left\">28. 5. 1. <span data-subsection=\"285.1\">Contrôle de la masse moyenne</span></h2><ol><li><p style=\"text-align: left\"><span data-question=\"1\">Effectuer le calibrage interne de la balance /carry out the internal calibration of the scale</span></p></li></ol><table data-table-form-id=\"833\" data-question-id=\"876\" 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\">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\"><span data-question=\"2\">Prélever 20 comprimés avant pelliculage /take a sample of 20 tablet before coating</span></p><table data-table-form-id=\"1051\" data-question-id=\"1090\" data-header-orientation=\"horizontal\" data-table-form-status=\"created\" style=\"min-width: 547px\"><colgroup><col style=\"width: 258px\"><col style=\"width: 239px\"><col style=\"min-width: 25px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\" colwidth=\"258\"><p style=\"text-align: left\">Norme</p></th><th colspan=\"1\" rowspan=\"1\" colwidth=\"239\"><p style=\"text-align: left\">Masse min</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Masse max</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Masse moyenne 20 comprimés avant pelliculage /average weight of 20 tablet before coating</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\" colwidth=\"258\"><p style=\"text-align: left\">La masse moyenne doit être de/the average weight must be 100 mg ±3% masse/mass min : 97 mg et masse/mass max: 103 mg</p></td><td colspan=\"1\" rowspan=\"1\" colwidth=\"239\"><p style=\"text-align: left\">97 mg</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\"></p></td></tr></tbody></table></li></ol><ol start=\"3\"><li><p style=\"text-align: left\">La masse moyenne doit être de/the average weight must be 100 mg ±3% masse/mass min : 97 mg et masse/mass max: 103 mg</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=\"4\"><li><p style=\"text-align: left\">Prélever 20 comprimés après pelliculage /take a sample after coating</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\"><span data-question=\"3\">Coller ici étiquette de pesée /attach weighing label</span></p><table data-table-form-id=\"836\" data-question-id=\"878\" 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\">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\"><span data-question=\"4\">Relever la masse moyenne des 20 comprimés qui doit être la masse moyenne lors de la compression + gain en poids 3%±3%/indicate the average mass of 20 tablets that must be the average mass during compression + gain in weight 3% ± 3% . Remplir le tableau ci-dessous/fill the table bellow</span></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\">Masse moyenne 20 comprimés avant pelliculage /average weight of 20 tablet before coating</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Masse min</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Masse max</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\">97 mg</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">103 mg</p></td></tr></tbody></table><p style=\"text-align: left\">Masse moyenne 20 comprimés théorique à atteindre / Average mass 20 tablets theoretical to reach</p><table data-table-form-id=\"837\" data-question-id=\"879\" data-header-orientation=\"horizontal\" data-table-form-status=\"created\" style=\"min-width: 339px\"><colgroup><col style=\"min-width: 25px\"><col style=\"width: 239px\"><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\">Masse moyenne 20</p><p style=\"text-align: left\">comprimés théorique à atteindre / Average mass 20 tablets theoretical to reach</p><p style=\"text-align: left\"></p></th><th colspan=\"1\" rowspan=\"1\" colwidth=\"239\"><p style=\"text-align: left\">Temps écoulé de pulvérisation</p><p style=\"text-align: left\">/spraying time</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">T (min)</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">T (min)</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">T (min)</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">-</p></td><td colspan=\"1\" rowspan=\"1\" colwidth=\"239\"><p style=\"text-align: left\">Temps</p></td><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\">Masse min 99.91 mg</p></td><td colspan=\"1\" rowspan=\"1\" colwidth=\"239\"><p style=\"text-align: left\">Masse 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\">Masse max 106.09 mg</p></td><td colspan=\"1\" rowspan=\"1\" colwidth=\"239\"><p style=\"text-align: left\">Masse max</p></td><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\" colwidth=\"239\"><p style=\"text-align: left\">Masse moyenne</p></td><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\"><span data-question=\"5\">Fait par/Vérifié par</span></p><table data-table-form-id=\"838\" data-question-id=\"880\" 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\">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><h2 style=\"text-align: left\">28. 5. 2. <span data-subsection=\"285.2\">Contrôle de l\'aspect/appearence control</span></h2><p style=\"text-align: left\"></p><ol><li><p style=\"text-align: left\"><span data-question=\"1\">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</span></p><table data-table-form-id=\"1052\" data-question-id=\"1091\" data-header-orientation=\"vertical\" 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\">Norme</p></th><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Comprimé pelliculé jaune foncé, de forme ronde 6 mm, légèrement biconvexe/Dark yellow, round-shaped 6mm, slightly biconvex, film-coated tablet</p></td></tr><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Vérifié par date et visa /checked by date and signature</p></th><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><p style=\"text-align: left\"><span data-question=\"2\">Vérifier l\'absence des défauts suivants</span></p><table data-table-form-id=\"840\" data-question-id=\"882\" data-header-orientation=\"vertical\" data-table-form-status=\"created\" style=\"min-width: 337px\"><colgroup><col style=\"width: 312px\"><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\" colwidth=\"312\"><p style=\"text-align: left\">Absence d\'arrachement et de collage des comprimés/ Absence of tablet picking and sticking</p></th><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">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</p></td></tr><tr><th colspan=\"1\" rowspan=\"1\" colwidth=\"312\"><p style=\"text-align: left\">Absence de rugosité de surface/ Absence of surface roughness</p></th><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">ressemblant souvent à de la peau d\'orange/ often resembling orange peel</p></td></tr><tr><th colspan=\"1\" rowspan=\"1\" colwidth=\"312\"><p style=\"text-align: left\">Absence d\'érosion de la surface des comprimés</p></th><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Absence of tablet surface erosion</p></td></tr><tr><th colspan=\"1\" rowspan=\"1\" colwidth=\"312\"><p style=\"text-align: left\">Absence de variabilité excessive des couleurs d\'une tablette à l\'autre</p></th><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Absence of excessive tablet- to-tablet color variability</p></td></tr></tbody></table><p style=\"text-align: left\">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</p></li></ol><p style=\"text-align: left\">/ 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.</p><p style=\"text-align: left\"></p><p style=\"text-align: left\"><span data-question=\"3\">Vérifier la conformité de l\'aspect et les dimensions des comprimés</span></p><table data-table-form-id=\"841\" data-question-id=\"883\" 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\">Contrôle aspect</p><p style=\"text-align: left\">/appearance control</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">T (min)</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">T (min)</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">T (min)</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Temps</p></td><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\">Comp/ tablet 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\">Comp/ tablet 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><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Comp/ tablet 3</p></td><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\">Comp/ tablet 4</p></td><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\">Comp/ tablet 5</p></td><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\">Comp/ tablet 6</p></td><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\">Comp/ tablet 7</p></td><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\">Comp/ tablet 8</p></td><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\">Comp/ tablet 9</p></td><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\">Comp/ tablet 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></tbody></table><ol start=\"2\"><li><p style=\"text-align: left\"><span data-question=\"4\">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.</span></p></li></ol><table data-table-form-id=\"842\" data-question-id=\"885\" 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\">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\"><span data-question=\"5\">Procéder à la déconnexion de la T bin de chargement selon l\'instructionen vigueur Effectuer le cycle de nettoyage avant déconnexion</span></p></li></ol><table data-table-form-id=\"843\" data-question-id=\"886\" 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\">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\"><span data-question=\"6\">Entamer le cycle de nettoyage de la machine selon l\'instructionen vigueur /At the end of the film coating Close the container of the tablets and attach an identification label: The tablets are stored in suitable containers with double air-tight polythene bags identified with labels reporting: product name, batch number, amount, and code/ proceed to the disconnection of the loading T bin according to the SOP Carry out the cleaning cycle before disconnection Start the cleaning cycle of the machine according to the SOP</span></p></li></ol><table data-table-form-id=\"844\" data-question-id=\"887\" 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\">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\"><span data-section=\"29\">RECONCILIATION DU PELLICULAGE / FILM COATING YIELD CALCULATION</span></h1><p style=\"text-align: left\"><span data-question=\"1\">Equipements</span></p><table data-table-form-id=\"382\" data-question-id=\"408\" data-header-orientation=\"vertical\" 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\">Code /code</p></th><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><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Désignation équipement/equipment designation</p></th><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><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Dernière date de qualification/étalonnage / last calibration and qualification date</p></th><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><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 /scale réconciliation</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">EQ HP DSM 12</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\">Indiquer le poids de la T bin remplie avant pelliculage /indicate the Filled Tbin weight before coating</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 T bin</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Poids T bin remplie</p><p style=\"text-align: left\">/filled T bin weight</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</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></tr></tbody></table><p style=\"text-align: left\">coller ici étiquette de pesée /attach weighing label</p><ol start=\"2\"><li><p style=\"text-align: left\">Indiquer le poids de conteneur des comprimés pelliculés /indicate the weight of the container of film coated tablet</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\"><span data-question=\"6\">Indiquer les données suivantes : /indicate the following information</span></p></li></ol><table data-table-form-id=\"387\" data-question-id=\"413\" data-header-orientation=\"vertical\" 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><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Masse totale /total weight (g)</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Nombre de comprimé/tablet number</p></td></tr><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Quantité théorique/theoretical quantity</p></th><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><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Quantité réelle /real quantity</p></th><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><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Perte contrôle en cours /in process control loss</p></th><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><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Quantité prélevée /sampled quantity</p></th><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\"><span data-question=\"7\">Fait par/Vérifié par</span></p><table data-table-form-id=\"388\" data-question-id=\"414\" 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\">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\"><span data-question=\"8\">Calculer le % de gain en poids/ calculate the weight gain % de gain en poids = (poids des comprimés après pelliculage - poids des comprimés avant pelliculage) /poids des comprimés avant pelliculage % of weight gain = (weight of tablets after film coating - weight of tablets before film coating) / weight of tablets before film coating</span></p></li></ol><table data-table-form-id=\"1053\" data-question-id=\"1092\" data-header-orientation=\"vertical\" 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\">Paramètre</p></th><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Poids total des comprimés/tabl et total weight</p></td></tr><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Avant pelliculage</p><p style=\"text-align: left\">/before film coating (Kg)</p></th><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Après pelliculage</p><p style=\"text-align: left\">/after film coating (Kg)</p></th><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">% de gain en poids /% of weight gain</p></th><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Fait par date et visa /done by date and signature</p></th><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><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><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><ol start=\"5\"><li><p style=\"text-align: left\"><span data-question=\"9\">Joindre les étiquettes de pesée à cette page/attach the weighing label to this page</span></p></li></ol><table data-table-form-id=\"390\" data-question-id=\"416\" 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\">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\"><span data-question=\"10\">Effectuer la pesée de la suspension de pelliculage restante et remplir le tableau ci-joint /carry out the film coating suspension weighing anf fill the table below</span></p></li></ol><table data-table-form-id=\"391\" data-question-id=\"417\" data-header-orientation=\"vertical\" data-table-form-status=\"created\" 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><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Paramètre</p></td><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Avant pelliculage</p><p style=\"text-align: left\">/before film coating (Kg)</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Après pelliculage</p><p style=\"text-align: left\">/after film coating (Kg)</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Quanité consommé/con s umed quantity (%)</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</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\">Poids total de la suspension</p><p style=\"text-align: left\">/suspension total weight</p></td><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\">Date et heure fin ending hour and date</p><p style=\"text-align: left\">Visa et date superviseur signature and date supervisor :</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 112 / 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><h1 style=\"text-align: left\"><span data-section=\"30\">GESTION DES DECHETS/WASTE MANAGEMENT</span></h1><p style=\"text-align: left\"><span data-question=\"1\">Date et heure début/date and hour of starting</span></p><table data-table-form-id=\"394\" data-question-id=\"420\" data-header-orientation=\"horizontal\" data-table-form-status=\"created\" style=\"min-width: 25px\"><colgroup><col style=\"min-width: 25px\"></colgroup><tbody><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Date et heure début/date and hour of starting</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><p style=\"text-align: left\">Type de déchets / waste type: Pharmaceutique/pharmaceutical</p><p style=\"text-align: left\"></p><p style=\"text-align: left\"></p><p style=\"text-align: left\"><span data-question=\"2\">Déchets de Mélange</span></p><table data-table-form-id=\"395\" data-question-id=\"421\" data-header-orientation=\"vertical\" 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><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Désignation</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Mélange/blend</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Valeur/Value</p></td></tr><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Type de déchets / waste type</p></th><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Pharmaceutique/pharmaceutical</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Quantité / qunatity</p></th><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><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Motif du rejet / Reason for rejection</p></th><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Mélange récupéré du bas de l\'aspirateur + sabot de la machine</p><p style=\"text-align: left\">/blendfromtheexaust system and machine feeder</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><p style=\"text-align: left\"><span data-question=\"3\">Déchets de compression 1</span></p><table data-table-form-id=\"396\" data-question-id=\"422\" data-header-orientation=\"vertical\" 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><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Désignation</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Comprimés nus/uncoated tablet</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Valeur/Value</p></td></tr><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Type de déchets / waste type</p></th><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Pharmaceutique/pharmaceutical</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Quantité / qunatity</p></th><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><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Quantité / qunatity</p></th><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><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Motif du rejet / Reason for rejection</p></th><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Comprimés de réglage machine/setti ng tablet :</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></th><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Comprimés controle en cours : /IPC tablet</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></th><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Comprimés rejetés par détecteur de métaux /tablet rejected by metal detector</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><p style=\"text-align: left\"><span data-question=\"4\">Déchets de compression 2</span></p><table data-table-form-id=\"397\" data-question-id=\"423\" data-header-orientation=\"vertical\" 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><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Désignation</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Comprimés pelliculés/film coated tablet</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Valeur/Value</p></td></tr><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Type de déchets / waste type</p></th><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Pharmaceutique/pharmaceutical</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Quantité / qunatity</p></th><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><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Motif du rejet / Reason for rejection</p></th><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Comprimés cassés, ébréchés /Tablets broken, chipped</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\">Désignation</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Mélange/blend</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Comprimés nus/uncoated tablet</p></th><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Comprimés pelliculés/film coated tablet</p></th></tr><tr><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Quantité / qunatity</p></td><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\">Motif du rejet / Reason for rejection</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Mélange récupéré du bas de l\'aspirateur + sabot de la machine</p><p style=\"text-align: left\">/blend from the exaust system and machine feeder</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Comprimés de réglage machine/setti ng tablet :</p></td><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Comprimés cassés, ébréchés /Tablets broken, chipped</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><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\">Comprimés controle en cours : /IPC tablet</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><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\">Comprimés rejetés par détecteur de métaux</p><p style=\"text-align: left\">/tablet rejected by metal detector</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\"><span data-question=\"5\">Fait par / Vérifié par</span></p><table data-table-form-id=\"398\" data-question-id=\"424\" 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\">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 /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 hour and date</p><p style=\"text-align: left\">Visa et date superviseur: signature and date supervisor</p><p style=\"text-align: left\"></p><p style=\"text-align: left\"><strong>31.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </strong><span data-section=\"31\"><strong>DEVIATIONS, ET DECISON DU PCP/DEVIATION AND PRODUCTION DECISON</strong></span></p><p style=\"text-align: left\"></p><p style=\"text-align: left\"><span data-question=\"1\">Déviation, et decision du pcp/deviation and production pharmacist decison</span></p><p style=\"text-align: left\"></p><table data-table-form-id=\"1056\" data-question-id=\"1095\" data-header-orientation=\"vertical\" 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\"></p></th><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">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</p><p style=\"text-align: left\">document above</p></td></tr><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">N° déviation /deviation number</p></th><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Déviation /deviation</p></th><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Date et signature de l\'Ingénieur responsable production /production Engineer</p></th><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr><tr><th colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\">Date et signature du Pharmacien chargé des opérations de production /production pharmacist</p></th><td colspan=\"1\" rowspan=\"1\"><p style=\"text-align: left\"></p></td></tr></tbody></table><p style=\"text-align: left\"></p>','{\"edit_count\": 615, \"last_edited\": \"2025-11-06T13:39:20+00:00\", \"tiptap_json\": {\"type\": \"doc\", \"content\": [{\"type\": \"table\", \"attrs\": {\"data-question-id\": null, \"data-table-form-id\": null, \"data-table-form-status\": null, \"data-header-orientation\": null}, \"content\": [{\"type\": \"tableRow\", \"content\": [{\"type\": \"tableHeader\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}}]}, {\"type\": \"tableHeader\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}, \"content\": [{\"text\": \"Rédaction/ redaction\", \"type\": \"text\", \"marks\": [{\"type\": \"bold\"}]}]}]}, {\"type\": \"tableHeader\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}, \"content\": [{\"text\": 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[{\"type\": \"bold\"}]}]}]}, {\"type\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}, \"content\": [{\"text\": \"Feriel MRABET\", \"type\": \"text\"}]}]}, {\"type\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}, \"content\": [{\"text\": \"Donia FOUDHAILI\", \"type\": \"text\"}]}]}, {\"type\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}, \"content\": [{\"text\": \"Salha GARBAYA\", \"type\": \"text\"}]}]}, {\"type\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}, \"content\": [{\"text\": \"Mahmoud ALSWISSI\", \"type\": \"text\"}]}]}, {\"type\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}, \"content\": [{\"text\": \"Mohamed Amine BOUJBEL\", \"type\": \"text\"}]}]}]}, {\"type\": \"tableRow\", \"content\": [{\"type\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}, \"content\": [{\"text\": \"Signature\", \"type\": \"text\", \"marks\": [{\"type\": \"bold\"}]}]}, {\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}, \"content\": [{\"text\": \"/Signature\", \"type\": \"text\", \"marks\": [{\"type\": \"bold\"}]}]}]}, {\"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\": \"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\": \"Date /date\", \"type\": \"text\", \"marks\": [{\"type\": \"bold\"}]}]}]}, {\"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\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}}]}]}]}, {\"type\": \"heading\", \"attrs\": {\"level\": 1, \"textAlign\": \"left\"}, \"content\": [{\"text\": \"REGISTRE DE REVISION /MODIFICATION SUMMARY\", \"type\": \"text\"}]}, {\"type\": \"table\", \"attrs\": {\"data-question-id\": null, \"data-table-form-id\": null, \"data-table-form-status\": null, \"data-header-orientation\": null}, \"content\": [{\"type\": \"tableRow\", \"content\": [{\"type\": \"tableHeader\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}, \"content\": [{\"text\": \"Numéro de l\'ancienne version\", \"type\": \"text\", \"marks\": [{\"type\": \"bold\"}]}]}, {\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}, \"content\": [{\"text\": \"/last version number\", \"type\": \"text\", \"marks\": [{\"type\": \"bold\"}]}]}]}, {\"type\": \"tableHeader\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}, \"content\": [{\"text\": \"Les modifications apportées sont/section modifiée (§)/modification description\", \"type\": \"text\", \"marks\": [{\"type\": \"bold\"}]}]}]}, {\"type\": \"tableHeader\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}, \"content\": [{\"text\": \"Date de modificati on/modific ation date\", \"type\": \"text\", \"marks\": [{\"type\": \"bold\"}]}]}]}, {\"type\": \"tableHeader\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}, \"content\": [{\"text\": \"Modifiée par\", \"type\": \"text\", \"marks\": [{\"type\": \"bold\"}]}]}, {\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}, \"content\": [{\"text\": \"/modified by\", \"type\": \"text\", \"marks\": [{\"type\": \"bold\"}]}]}]}, {\"type\": \"tableHeader\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}, \"content\": [{\"text\": \"Numéro de la nouvelle version/new version number\", \"type\": \"text\", \"marks\": [{\"type\": 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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\", \"type\": \"text\"}]}, {\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}, \"content\": [{\"text\": \"1.5 g to 5 g Change the number of\", \"type\": \"text\"}]}, {\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}, \"content\": [{\"text\": \"tablets for hardness test from 8 to 10 tablets Add protection to the film coating suspension after preparation and during film coating\", \"type\": \"text\"}]}]}, {\"type\": \"tableCell\", \"attrs\": {\"colspan\": 1, \"rowspan\": 1, \"colwidth\": null}, \"content\": [{\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}, \"content\": [{\"text\": \"07/01/2020\", \"type\": 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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 =\", \"type\": \"text\"}]}, {\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}, \"content\": [{\"text\": \"....................... Lot N°2 T2 = Q1 =\", \"type\": \"text\"}]}, {\"type\": \"paragraph\", \"attrs\": {\"textAlign\": \"left\"}, \"content\": [{\"text\": \"....................... 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