Plasma-derived medicinal products - Scientific guideline
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.
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
-
List item
Guideline on plasma-derived medicinal products (PDF/323.79 KB)
Adopted
First published: 29/07/2011
Last updated: 29/07/2011
EMA/CHMP/BWP/706271/2010 -
List item
Overview of comments received on guideline on plasma-derived medicinal products EMA/CHMP/BWP/706271/2010 (formerly CPMP/BWP/269/95 rev. 3) (PDF/260.47 KB)
First published: 28/10/2011
Last updated: 28/10/2011
EMA/360578/2010 -
List item
Draft guideline on plasma-derived medicinal products (PDF/258.92 KB)
Draft: consultation closed
First published: 19/02/2009
Last updated: 19/02/2009
CPMP/BWP/269/95 rev. 4 -
List item
Concept paper on the revision of the note for guidance on plasma-derived medicinal products (PDF/76.56 KB)
First published: 06/12/2006
Last updated: 06/12/2006
EMEA/CHMP/BWP/495530/2006
-
List item
Guideline on assessing the risk for virus transmission - new chapter 6 of the note for guidance on plasma derived medicinal products (CPMP/BWP/269/95) (PDF/172.04 KB)
Adopted
First published: 30/04/2005
Last updated: 30/04/2005
Legal effective date: 21/10/2004
CPMP/BWP/5180/03 -
List item
Note for guidance on plasma-derived medicinal products (PDF/269.88 KB)
Adopted
First published: 25/01/2001
Last updated: 25/01/2001
Legal effective date: 31/01/2001
CHMP/BWP/269/95/ rev. 3