This 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.
Keywords: Active substance, biologics, process validation, process evaluation, process verification, lifecycle
Current effective version
Guideline on process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission
The guideline covers process validation which includes process characterisation and process verification of biotechnology-derived active substances in the manufacture of medicinal products. This guideline addresses the data requirements for process characterisation and verification for submission of a marketing authorisation application or variation.
English (EN) (181.04 KB - PDF)
Document history
Overview of comments received on 'Guideline on process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission'
EMA/CHMP/BWP/187338/2014
English (EN) (653.21 KB - PDF)
Draft guideline on process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission
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.
English (EN) (159.52 KB - PDF)
Concept paper on the need for a guideline on process validation of medicinal products containing biotechnology-derived proteins as active substance
English (EN) (73.04 KB - PDF)
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