Real time release testing

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This guideline applies to human and veterinary medicines.

Current effective version

Revision 1 - Adopted guideline

Reference numberEMA/CHMP/QWP/811210/2009 Rev. 1
Effective from01/10/2012
KeywordsParametric release, batch release, sterilisation, process analytical technology, quality by design, real time release testing
DescriptionThis 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

Adopted guideline


Overview of comments


Draft guideline


Concept paper

In operation: 01/10/2012–present


Published: 13/04/2012


Published: 03/03/2010


Published: 26/11/2008

First versionAdopted guidelineIn operation: 01/09/2001–01/01/2012

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