Use of bovine serum in the manufacture of human biological medicinal products

  • Email
  • Help
Current effective version

Revision 1 - Adopted guideline

Reference numberCHMP/BWP/457920/2012 Rev. 1
Effective from01/12/2013
KeywordsBovine serum, adventitious agents, bovine viral diarrhoea virus (BVDV), viral inactivation
DescriptionThis document outlines the general principles that should be applied to the control of the quality and safety of bovine serum used during the manufacture of human biological medicinal products. It applies to vaccines and biotechnological products. It also covers dossier requirements for marketing authorisation applications/variations.

Document history

Revision 1 

Current version

Adopted guideline

Overview of comments

Draft guideline

In operation: 01/12/2013–present

Published: 04/06/2013

Published: 01/10/2012

First versionAdopted guidelineIn operation: 01/10/2003–01/12/2013

Related content

How helpful is this page?

Average rating:

 Based on 35 ratings

Add your rating:

See all ratings
7 ratings
7 ratings
7 ratings
7 ratings
7 ratings

Tell us more