Plasma-derived medicinal products

Current effective version

PDF iconRevision 4 - Adopted guideline

Reference number CPMP/BWP/706271/2010
Published 29/07/2011
Effective from 01/02/2012
Keywords Plasma-derived medicinal products, collection and control of starting materials, plasma master file, manufacture, quality control, process validation, virus safety and stability, plasma master file
Description This 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

PDF iconAdopted guideline


PDF iconOverview of comments


PDF iconDraft guideline


PDF iconConcept paper

In operation: 01/02/2012–present


Published: 28/10/2011


Published: 19/02/2009


Published: 06/12/2006

Revision 3

PDF iconAdopted guideline - Chapter 6


PDF iconAdopted guideline

In operation: 21/10/2004–01/02/2012


In operation: 31/01/2001–01/02/2012

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