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
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Guideline on manufacture of the finished dosage form - Revision 1 (PDF/210.56 KB)
Adopted
First published: 14/08/2017
Last updated: 14/08/2017
EMA/CHMP/QWP/245074/2015 -
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Overview of comments received on 'Draft Guideline on manufacture of the finished dosage form' (EMA/CHMP/QWP/245074) - Revision 1 (PDF/599.53 KB)
First published: 17/11/2017
Last updated: 17/11/2017
EMA/CHMP/QWP/104223/2016 -
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Draft guideline on manufacture of the finished dosage form - Revision 1 (PDF/306.54 KB)
Draft: consultation closed
First published: 09/07/2015
Last updated: 09/07/2015
Consultation dates: 09/07/2015 to 09/01/2016
EMA/CHMP/QWP/245074/2015 -
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Draft concept paper on the need for revision of the note for guidance on manufacture of the finished dosage form - Revision 1 (PDF/96.73 KB)
Draft: consultation closed
First published: 04/07/2013
Last updated: 04/07/2013
Consultation dates: 04/07/2013 to 31/12/2013
EMA/CHMP/QWP/324350/2013