Use of bovine serum in the manufacture of human biological medicinal products - Scientific guideline
Table of contents
This 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.
Keywords: Bovine serum, adventitious agents, bovine viral diarrhoea virus (BVDV), viral inactivation
-
List item
Guideline on the use of bovine serum in the manufacture of human biological medicinal products - Revision 1 (PDF/130.18 KB)
Adopted
First published: 04/06/2013
Last updated: 04/06/2013
Legal effective date: 01/12/2013
EMA/CHMP/BWP/457920/2012 Rev 1 -
List item
Overview of comments received on 'Guideline on the use of bovine serum in the manufacture of human biological medicinal products' (PDF/163.97 KB)
First published: 04/06/2013
Last updated: 04/06/2013
EMA/CHMP/BWP/596/2013 -
List item
Draft guideline on the use of bovine serum in the manufacture of human biological medicinal products (PDF/95.4 KB)
Draft: consultation closed
First published: 01/10/2012
Last updated: 01/10/2012
Consultation dates: 01/10/2012 to 31/12/2012
EMA/CHMP/BWP/457920/2012 Rev. 1