Guideline on process validation for finished products ...

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

Process validation data should be generated for all products to demonstrate the adequacy of the manufacturing process at each site of manufacture. Validation should be carried out in accordance with GMP and data should be held at the manufacturing location and made available for inspection if not required in the dossier (see section 8).

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  Data, Process, Validation, Process validation, Process validation data

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