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

Current effective version

Guideline on process validation for finished products - information and data to be provided in regulatory submissions - Revision 1

AdoptedReference Number: EMA/CHMP/CVMP/QWP/BWP/70278/2012 Rev. 1, Corr. 1Summary:

This guideline replaces the previous note for guidance on process validation (CPMP/QWP/848/96, (EMEA/CVMP/598/99). The guideline is brought into line with ICH Q8, Q9 and Q10 documents and

the possibility to use continuous process verification in addition to, or instead of, traditional process validation described in the previous guideline has been added and is encouraged.

Document history - Revision 1 (current version)

Guideline on process validation for finished products - information and data to be provided in regulatory submissions - Revision 1

AdoptedReference Number: EMA/CHMP/CVMP/QWP/BWP/70278/2012 Rev. 1, Corr. 1Summary:

This guideline replaces the previous note for guidance on process validation (CPMP/QWP/848/96, (EMEA/CVMP/598/99). The guideline is brought into line with ICH Q8, Q9 and Q10 documents and

the possibility to use continuous process verification in addition to, or instead of, traditional process validation described in the previous guideline has been added and is encouraged.

Overview of comments received on the guideline on process validation for finished products - information and data to be provided in regulatory submissions - Revision 1

Reference Number: EMA/659397/2013Summary:

Submission of comments on the ‘Guideline on process validation for finished products - information and data to be provided in regulatory submissions' (EMA/CHMP/CVMP/QWP/70278/2012-Rev1)

Draft guideline on process validation - Revision 1

Consultation dates: 15/03/2012 to 31/10/2012Draft: consultation closedReference Number: EMA/CHMP/CVMP/QWP/70278/2012-Rev1Summary:

This guideline replaces the previous guideline on process validation. The guideline is brought into line with International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Q8, Q9 and Q10 documents and the possibility to use continuous process verification in addition to, or instead of, traditional process verification described in the previous guideline has been added.

Concept Paper on the Revision of the Guideline on Process Validation - Revision 1

Consultation dates: 14/01/2010 to 31/05/2010Draft: consultation closedReference Number: EMA/CHMP/CVMP/QWP/809114/2009

Document history - First version

Note for guidance on process validation

AdoptedLegal effective date: 01/09/2001Reference Number: CPMP/QWP/848/96

Annex II to note for guidance on process validation CHMP/QWP/848/99 and EMEA/CVMP/598/99 non standard processes

AdoptedLegal effective date: 01/01/2005Reference Number: CPMP/QWP/2054/03