Process validation for finished products – information and data to be provided in regulatory submissions

  • Email
  • Help

This guideline applies to human and veterinary medicines.

Current effective version

Revision 1 - Adopted guideline

Reference numberEMA/CHMP/CVMP/QWP/BWP/70278/2012 Rev. 1
Published28/02/2014
Effective from29/08/2014
KeywordsProcess validation, continuous process verification, on-going process verification, critical process parameter, critical quality attribute, lifecycle, change control
DescriptionThis document provides guidance on the process validation information and data to be provided in regulatory submissions for the finished dosage forms of chemical medicinal products for human and veterinary use. The general principles also apply to active substances. The principles described are also applicable to biological medicinal products, but these should be considered on a case by case basis.


Document history

Revision 1
Current revision

Adopted guideline


Overview of comments


Draft guideline


Concept paper

In operation: 28/08/2014–present


Published: 28/02/2014


Published: 13/04/2012


Published: 03/03/2010

First version


 

Adopted guideline


Annex II - Adopted guideline 

In operation: 01/09/2001–27/08/2014


In operation: 01/01/2005–27/08/2014


Related content for human medicines



Related content for veterinary medicines


How helpful is this page?

Average rating:

 Based on 7 ratings

Add your rating:

See all ratings
0 ratings
0 ratings
1 ratings
1 ratings
5 ratings
    

Tell us more