Draft guideline on process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission

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Document details

Download document Draft guideline on process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission
Reference number EMA/CHMP/BWP/187338/2014
Status draft: consultation open
First published 30/04/2014
Last updated 30/04/2014
Consultation start date 01/05/2014
Consultation end date 31/10/2014
Email address for submissions bwpsecretariat@ema.europa.eu

Summary

Guidance is provided on data requirements for process validation of biotechnology-derived proteins used as active substance in the manufacture of medicinal products. This guideline covers process evaluation and verification studies for the upstream and downstream process, in the context of a marketing authorisation application or a variation application if relevant.