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

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Current effective version

Revision 1 - Adopted guideline

Reference numberCHMP/BWP/457920/2012 Rev. 1
Published04/06/2013
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


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