Plasma-derived medicinal products

  • Email
  • Help
Current effective version

Revision 4 - Adopted guideline

Reference numberCPMP/BWP/706271/2010
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

Related content

How helpful is this page?

Average rating:

 Based on 30 ratings

Add your rating:

See all ratings
6 ratings
6 ratings
6 ratings
6 ratings
6 ratings

Tell us more