Use of porcine trypsin used in the manufacture of human biological medicinal products

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Current effective version

Adopted guideline

Reference numberEMA/CHMP/BWP/814397/2011
Published28/02/2014
Effective from01/09/2014
KeywordsPorcine trypsin, adventitious agents, virus
DescriptionThis document covers the viral safety aspects of human biological medicinal products using porcine trypsin.


Document history

First version

Current version

Adopted guideline


Overview of comments


Draft guideline


Concept paper

In operation: 01/09/2014–present


Published: 04/03/2014


Published: 01/03/2013


Published: 20/11/2008


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