English: DRUG PRODUCT -------------------------------------------------------------------------------------------------------------3 6.4.1 Description of the drug product--------------------------------------------------------------------------------------3 6.4.2 Pharmaceutical Development ----------------------------------------------------------------------------------------3 6.4.3 Method of Manufacture -----------------------------------------------------------------------------------------------3 6.4.3.1 Manufacturer(s) ------------------------------------------------------------------------------------------------------------------ 3 6.4.3.2 Formulae -------------------------------------------------------------------------------------------------------------------------- 3 6.4.3.2.1 Quantitative formula ------------------------------------------------------------------------------------------------------- 3 6.4.3.2.2 Batch formula --------------------------------------------------------------------------------------------------------------- 3 6.4.3.3 Manufacturing Process ---------------------------------------------------------------------------------------------------------- 3 6.4.3.3.1 Description ------------------------------------------------------------------------------------------------------------------ 3 6.4.3.3.2 Master Production Documents-------------------------------------------------------------------------------------------- 3 6.4.3.3.3 Executed Production Documents----------------------------------------------------------------------------------------- 3 6.4.3.4 Process Validation --------------------------------------------------------------------------------------------------------------- 3 6.4.3.4.1 Sterile Products ------------------------------------------------------------------------------------------------------------- 3 6.4.3.4.2 Non-sterile products-------------------------------------------------------------------------------------------------------- 3 6.4.3.5 Control of Excipients ------------------------------------------------------------------------------------------------------------ 3 6.4.3.5.1 Specifications --------------------------------------------------------------------------------------------------------------- 3 6.4.3.5.2 Analytical Procedures and Validation ----------------------------------------------------------------------------------- 3 6.4.3.5.3 Justification of specifications --------------------------------------------------------------------------------------------- 3 6.4.3.5.4 Medicinal and Non-Medicinal Ingredients of Animal Origin -------------------------------------------------------- 3 6.4.3.5.5 Novel Excipients ----------------------------------------------------------------------------------------------------------- 3
French: PRODUIT PHARMACEUTIQUE --------------------------------------------------------------------------------------------- 45 6.4.1 Description du produit pharmaceutique -------------------------------------------------------------------------- 47 6.4.2 Développement pharmaceutique ----------------------------------------------------------------------------------- 48 6.4.3 Méthode de fabrication---------------------------------------------------------------------------------------------- 48 6.4.3.1 Fabricant(s) --------------------------------------------------------------------------------------------------------------------- 48 6.4.3.2 Formules ------------------------------------------------------------------------------------------------------------------------ 49 6.4.3.2.1 Formule quantitative ----------------------------------------------------------------------------------------------------- 49 6.4.3.2.2 Formule de lot------------------------------------------------------------------------------------------------------------- 50 6.4.3.3 Procédés de fabrication-------------------------------------------------------------------------------------------------------- 50 6.4.3.3.1 Description ---------------------------------------------------------------------------------------------------------------- 50 6.4.3.3.2 Documents-types de production ---------------------------------------------------------------------------------------- 51 6.4.3.3.3 Documents-types de production ---------------------------------------------------------------------------------------- 52 6.4.3.4 Validation des procédés ------------------------------------------------------------------------------------------------------- 53 6.4.3.4.1 Produits stériles ----------------------------------------------------------------------------------------------------------- 54 6.4.3.4.2 Produits non stériles------------------------------------------------------------------------------------------------------ 55 6.4.3.5 Contrôle des excipients-------------------------------------------------------------------------------------------------------- 56 6.4.3.5.1 Spécifications ------------------------------------------------------------------------------------------------------------- 56 6.4.3.5.2 Procédures analytiques et validation----------------------------------------------------------------------------------- 57 6.4.3.5.3 Justification des spécifications ----------------------------------------------------------------------------------------- 57 6.4.3.5.4 Ingrédients médicinaux et non médicinaux d’origine animale ----------------------------------------------------- 58 6.4.3.5.5 Excipients nouveaux ----------------------------------------------------------------------------------------------------- 58