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

  • Email
  • Help
Current effective versionAdopted guideline
Reference numberEMA/CHMP/BWP/187338/2014
Published29/04/2016
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


Related content


How helpful is this page?

Average rating:

 Based on 0 ratings

Add your rating:

See all ratings
0 ratings
0 ratings
0 ratings
0 ratings
0 ratings
    

Tell us more