Process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission

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Current effective versionAdopted guideline
Reference numberEMA/CHMP/BWP/187338/2014
Effective from01/11/2016
KeywordsActive substance, biologics, process validation, process evaluation, process verification, lifecycle
DescriptionThis document covers process validation of biotechnology-derived proteins used as active substance in the manufacture of medicinal products. It addresses the data requirements for process validation for submission of a marketing authorisation application or variation.

Document history

First version

Current version

Adopted guideline

Overview of comments

Draft guideline

Concept paper

In operation: 01/11/2016

Published: 27/05/2016

Published: 30/04/2014

Published: 06/06/2011

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