Manufacture of the finished dosage form

Current effective version PDF iconRevision 1 - Adopted guideline
Reference numberEMA/CHMP/QWP/245074/2015
Published14/08/2017
Effective from14/02/2018
KeywordsManufacture, drug product
DescriptionThis 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.


Document history

Revision 1

Current version

PDF iconAdopted guideline

PDF iconOverview of comments

PDF iconDraft guideline


PDF iconConcept paper

In operation: 14/02/2018-present

Published: 17/11/2017

Published: 09/07/2015


Published: 04/07/2013

First version PDF iconAdopted guideline
Published: 01/04/1996


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