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

This guideline applies to human and veterinary medicines.

Current effective version

PDF iconRevision 1 - Adopted guideline

Reference number EMA/CHMP/CVMP/QWP/BWP/70278/2012 Rev. 1
Published 28/02/2014
Effective from 29/08/2014
Keywords Process validation, continuous process verification, on-going process verification, critical process parameter, critical quality attribute, lifecycle, change control
Description This 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

PDF iconAdopted guideline


PDF iconOverview of comments


PDF iconDraft guideline


PDF iconConcept paper

In operation: 28/08/2014–present


Published: 28/02/2014


Published: 13/04/2012


Published: 03/03/2010

First version

PDF iconAdopted guideline


PDF iconAnnex II - Adopted guideline

In operation: 01/09/2001–27/08/2014


In operation: 01/01/2005–27/08/2014

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