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

Current effective version

Guideline on plasma-derived medicinal products

Adopted Reference Number: EMA/CHMP/BWP/706271/2010 Summary:

This guideline provides guidance for the collection of starting material, the manufacturing and the quality control of plasma-derived medicinal products. Specific attention is given to the virus safety of these products.

Document history - Revision 4

Guideline on plasma-derived medicinal products

Adopted Reference Number: EMA/CHMP/BWP/706271/2010 Summary:

This guideline provides guidance for the collection of starting material, the manufacturing and the quality control of plasma-derived medicinal products. Specific attention is given to the virus safety of these products.

Overview of comments received on guideline on plasma-derived medicinal products EMA/CHMP/BWP/706271/2010 (formerly CPMP/BWP/269/95 rev. 3)

Reference Number: EMA/360578/2010

Draft guideline on plasma-derived medicinal products

Draft: consultation closed Reference Number: CPMP/BWP/269/95 rev. 4

Concept paper on the revision of the note for guidance on plasma-derived medicinal products

Reference Number: EMEA/CHMP/BWP/495530/2006

Document history - Revision 3

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)

Adopted Reference Number: CPMP/BWP/5180/03 Legal effective date: 21/10/2004

Note for guidance on plasma-derived medicinal products

Adopted Reference Number: CHMP/BWP/269/95/ rev. 3 Legal effective date: 31/01/2001