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
Published13/04/2012
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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