Real time release testing - Scientific guideline
Table of contents
This guideline applies to human and veterinary medicines.
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.
Keywords: Parametric release, batch release, sterilisation, process analytical technology, quality by design, real time release testing
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Guideline on real-time release testing (formerly guideline on parametric release) - Revision 1 (PDF/97.15 KB)
Adopted
First published: 13/04/2012
Last updated: 13/04/2012
Legal effective date: 01/10/2012
Consultation dates: 15/03/2012 to 31/10/2012
EMA/CHMP/QWP/811210/2009-Rev1 -
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Overview of comments received on draft guideline on real-time release testing (formerly guideline on parametric release) (PDF/306.94 KB)
First published: 13/04/2012
Last updated: 13/04/2012
Legal effective date: 01/10/2012
Consultation dates: 15/03/2012 to 31/10/2012
EMA/CHMP/QWP/142288/2012 -
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Draft guideline on Real Time Release Testing (formerly Guideline on Parametric Release) (PDF/113.35 KB)
Draft: consultation closed
First published: 03/03/2010
Last updated: 03/03/2010
Consultation dates: 17/12/2009 to 31/08/2010
EMA/CHMP/QWP/811210/2009 Rev 1 -
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Concept paper on the revision of the guideline on parametric release (PDF/46.74 KB)
First published: 26/11/2008
Last updated: 26/11/2008
EMEA/CHMP/QWP/569959/2008 -
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Note for guidance on parametric release (PDF/58.89 KB)
Adopted
First published: 01/03/2001
Last updated: 01/03/2001
Legal effective date: 01/09/2001
CPMP/QWP/3015/99