IGMPI India

EMA has recently issued draft guideline on manufacture of the finished dosage form. This guideline replaces the note for guidance on the manufacture of the finished dosage form. The objective of the guideline on the manufacture of the finished dosage form is to provide clarification on the type and level of information that should be included in the CTD Module 3 of the marketing authorisation application (MAA) dossier with respect to the manufacturing process description. The draft guideline contains:

• The note for guidance which has been updated to reflect changes to the format and content of the Common Technical Document (CTD) Module 3 dossier.
•  It also addresses current good manufacturing practices (GMP) in terms of complex supply chains and worldwide manufacture.
•  In addition, the content and principles of the ICH Q8 guideline is also taken into account.

This guideline should be read in conjunction with Directive 2001/83/EC Article 8.3 (d) (ref 2) where it is stated that the application for a marketing authorisation shall contain a description of the manufacturing method.

You can view the full guideline here.