Transcription of Guideline on process validation for the manufacture of ...
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Guideline on process validation for the manufacture of ...
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. 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)
Guideline on process validation for the manufacture of biotechnology-derived active substances and data to be prov ided in the regulatory submission
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