Manufacture of the finished dosage form

  • Email
  • Help
Current effective versionRevision 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

 

 

Adopted guideline

 

Overview of comments

 

Draft guideline


Concept paper

In operation: 14/02/2018-present

 

Published: 17/11/2017 

 

Published: 09/07/2015


Published: 04/07/2013

First versionAdopted guideline
 
Published: 01/04/1996


Related content


How helpful is this page?

Average rating:

 Based on 40 ratings

Add your rating:

See all ratings
8 ratings
7 ratings
6 ratings
6 ratings
13 ratings
    

Tell us more