Plasma-derived medicinal products

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Current effective version

Revision 4 - Adopted guideline

Reference numberCPMP/BWP/706271/2010
Published29/07/2011
Effective from01/02/2012
KeywordsPlasma-derived medicinal products, collection and control of starting materials, plasma master file, manufacture, quality control, process validation, virus safety and stability, plasma master file
DescriptionThis document provides guidance for the collection of starting material, the manufacturing and the quality control of plasma-derived medicinal products. It gives specific attention to the virus safety of these products.


Document history

Revision 4

Current version

Adopted guideline


Overview of comments


Draft guideline


Concept paper 

In operation: 01/02/2012–present


Published: 28/10/2011


Published: 19/02/2009


Published: 06/12/2006

Revision 3


 

Adopted guideline - Chapter 6


Adopted guideline

In operation: 21/10/2004–01/02/2012


In operation: 31/01/2001–01/02/2012


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