生物药工艺验证.pdf

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生物药工艺验证.pdf

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生物药工艺验证

28 April 2016 EMA/CHMP/BWP/187338/2014 Committee for Medicinal Products for Human Use (CHMP) Guideline on process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission Draft Agreed by Biologics Working Party April 2014 Adoption by CHMP for release for consultation 25 April 2014 Start of public consultation 1 May 2014 End of consultation (deadline for comments) 31 October 2014 BWP Drafting Group review of comments November 2014 - January 2016 Agreed by BWP February 2016 Adoption by CHMP 28 April 2016 Date for coming into effect 1 November 2016 Keywords active substance, biologics, process validation, process evaluation, process verification, lifecycle 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact An agency of the European Union © European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged. Guideline on process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission Table of contents Table of contents 2 1. Introduction 3 2. Scope 4 3. Legal basis 4 4. Process ch