Process validation for finished products – information and data to be provided in regulatory submissions - Scientific guideline
This guideline applies to human and veterinary medicines.
This document provides guidance on the process validation information and data to be provided in regulatory submissions for the finished dosage forms of chemical medicinal products for human and veterinary use. The general principles also apply to active substances. The principles described are also applicable to biological medicinal products, but these should be considered on a case by case basis.
Keywords: Process validation, continuous process verification, on-going process verification, critical process parameter, critical quality attribute, lifecycle, change control
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Guideline on process validation for finished products - information and data to be provided in regulatory submissions - Revision 1 (PDF/157.19 KB)
Adopted
First published: 28/02/2014
Last updated: 21/11/2016
EMA/CHMP/CVMP/QWP/BWP/70278/2012 Rev. 1, Corr. 1 -
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Overview of comments received on the guideline on process validation for finished products - information and data to be provided in regulatory submissions - Revision 1 (PDF/519.82 KB)
First published: 28/02/2014
Last updated: 28/02/2014
EMA/659397/2013 -
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Draft guideline on process validation - Revision 1 (PDF/123.75 KB)
Draft: consultation closed
First published: 13/04/2012
Last updated: 13/04/2012
Consultation dates: 15/03/2012 to 31/10/2012
EMA/CHMP/CVMP/QWP/70278/2012-Rev1 -
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Concept Paper on the Revision of the Guideline on Process Validation - Revision 1 (PDF/71.43 KB)
Draft: consultation closed
First published: 03/03/2010
Last updated: 03/03/2010
Consultation dates: 14/01/2010 to 31/05/2010
EMA/CHMP/CVMP/QWP/809114/2009
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Note for guidance on process validation (PDF/64.66 KB)
Adopted
First published: 01/03/2001
Last updated: 01/03/2001
Legal effective date: 01/09/2001
CPMP/QWP/848/96 -
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Annex II to note for guidance on process validation CHMP/QWP/848/99 and EMEA/CVMP/598/99 non standard processes (PDF/158.96 KB)
Adopted
First published: 10/08/2004
Last updated: 10/08/2004
Legal effective date: 01/01/2005
CPMP/QWP/2054/03