Real time release testing - Scientific guideline

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

Current effective version

Guideline on real-time release testing (formerly guideline on parametric release) - Revision 1

Adopted Consultation dates: 15/03/2012 to 31/10/2012 Reference Number: EMA/CHMP/QWP/811210/2009-Rev1 Legal effective date: 01/10/2012 Summary:

This guideline addresses the requirements for application of RTRT to different kinds of products e.g. chemical and biological products and its scope is to facilitate the introduction of RTR testing. The guideline is a revision of the guideline on parametric release and does not introduce new requirements.

Document history

Guideline on real-time release testing (formerly guideline on parametric release) - Revision 1

Adopted Consultation dates: 15/03/2012 to 31/10/2012 Reference Number: EMA/CHMP/QWP/811210/2009-Rev1 Legal effective date: 01/10/2012 Summary:

This guideline addresses the requirements for application of RTRT to different kinds of products e.g. chemical and biological products and its scope is to facilitate the introduction of RTR testing. The guideline is a revision of the guideline on parametric release and does not introduce new requirements.

Overview of comments received on draft guideline on real-time release testing (formerly guideline on parametric release)

Consultation dates: 15/03/2012 to 31/10/2012 Reference Number: EMA/CHMP/QWP/142288/2012 Legal effective date: 01/10/2012

Draft guideline on Real Time Release Testing (formerly Guideline on Parametric Release)

Draft: consultation closed Consultation dates: 17/12/2009 to 31/08/2010 Reference Number: EMA/CHMP/QWP/811210/2009 Rev 1

Concept paper on the revision of the guideline on parametric release

Reference Number: EMEA/CHMP/QWP/569959/2008

Note for guidance on parametric release

Adopted Reference Number: CPMP/QWP/3015/99 Legal effective date: 01/09/2001