Manufacture of the finished dosage form (human) - Scientific guideline

This document provides clarification on the type and level of information that should be included in the common technical document module 3 of the marketing authorisation application dossier with respect to the manufacturing process description. It also addresses aspects related to increased outsourcing and new manufacturing practices such as complex manufacturing chains or issues with prolonged holding times and transportation conditions.

Keywords: Manufacture, drug product

Document history - Revision 1


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