Manufacture of the finished dosage form

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Current effective version

Adopted guideline

 

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

Reference numberCPMP/QWP/486/95
Published01/04/1996
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


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