Manufacture of the finished dosage form

  • Email
  • Help
Current effective version

Adopted guideline


Revision 1 enters into effect 14/02/2018 - see below

Reference numberCPMP/QWP/486/95
Effective from01/04/1996
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



Adopted guideline



Overview of comments


Draft guideline

Concept paper

Publised: 14/08/2017

Effective from: 14/02/2018


Published: 17/11/2017 


Published: 09/07/2015

Published: 04/07/2013

First version

Current version

Adopted guideline
In operation: 01/04/1996-14/02/2018

Related content

How helpful is this page?

Average rating:

 Based on 14 ratings

Add your rating:

See all ratings
3 ratings
2 ratings
1 ratings
1 ratings
7 ratings

Tell us more