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

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

AdoptedReference Number: EMA/CHMP/BWP/187338/2014Legal effective date: 01/11/2016Summary:

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.

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'

Reference Number: EMA/CHMP/BWP/337128/2016Summary:

EMA/CHMP/BWP/187338/2014

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

Draft: consultation closedConsultation dates: 01/05/2014 to 31/10/2014Reference Number: EMA/CHMP/BWP/187338/2014Summary:

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.

Concept paper on the need for a guideline on process validation of medicinal products containing biotechnology-derived proteins as active substance

Draft: consultation closedConsultation dates: 19/05/2011 to 31/08/2011Reference Number: EMA/CHMP/BWP/25360/2011