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

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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
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

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