Real time release testing

This guideline applies to human and veterinary medicines.

Current effective version

PDF iconRevision 1 - Adopted guideline

Reference number EMA/CHMP/QWP/811210/2009 Rev. 1
Published 13/04/2012
Effective from 01/10/2012
Keywords Parametric release, batch release, sterilisation, process analytical technology, quality by design, real time release testing
Description This document outlines the requirements for applications that propose real time release testing for active substances, intermediates and finished products. It addresses the need for interaction between quality assessors and good manufacturing practice inspectors in the approval process. This guideline is a revision of the guideline on parametric release and does not introduce new requirements.


Document history

Revision 1

Current version

PDF iconAdopted guideline


PDF iconOverview of comments


PDF iconDraft guideline


PDF iconConcept paper

In operation: 01/10/2012–present


Published: 13/04/2012


Published: 03/03/2010


Published: 26/11/2008

First version PDF iconAdopted guideline In operation: 01/09/2001–01/01/2012

Related content


How useful was this page?

Add your rating