Transcription of Guideline on process validation for finished …
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Guideline on process validation for finished …
30 Churchill Place Canary Wharf London E14 5EU United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged. 21 November 2016 EMA/CHMP/CVMP/QWP/BWP/70278/2012-Rev1, Committee for Medicinal Products for Human Use (CHMP) Committee for Medicinal Products for Veterinary Use (CVMP) Guideline on process validation for finished products - information and data to be provided in regulatory submissions Draft agreed by CHMP / CVMP Quality Working Party 2 February 2012 Adoption by CVMP for release for consultation 8 March 2012 Adoption by CHMP for release for consultation 15 March 2012 End of consultation (deadline for comments) 31 October 2012 Agreed by QWP 8 November 2013 Agreed by BWP 13 November 2013 Adoption by CHMP 19 December 2013 Adoption by CVMP 15 January 2014 Date for coming into effect 6 months after publication Minor update* 21 September 2016 Agreed by QWP and IWG 21 September 2016 Agreed by BWP 5 October 2016 Adoption by CHMP 10 November 2016 Adoption by CVMP 10 November 2016 Guideline on process validation for finished products - information and data to be provided in regulatory submissions EMA/CHMP/CVMP/QWP/749073/2016 Page 2/15 this Guideline replaces the note for guidance on process validation (CPMP/QWP/848/96, EMEA/CVMP/598/99) including annex II
This document is intended to provide guidance on the process validation information and da ta to be provided in regulatory submission s for the finished dosage forms of chemical medicinal products for
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