Plasma-derived medicinal products - Scientific guideline
HumanScientific guidelines
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
AdoptedReference Number: EMA/CHMP/BWP/706271/2010Summary:
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.
English (EN) (323.79 KB - PDF)
First published: Last updated:
Document history - Revision 4
Guideline on plasma-derived medicinal products
AdoptedReference Number: EMA/CHMP/BWP/706271/2010Summary:
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.
English (EN) (323.79 KB - PDF)
First published: Last updated:
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
English (EN) (260.47 KB - PDF)
First published: Last updated:
Draft guideline on plasma-derived medicinal products
Draft: consultation closedReference Number: CPMP/BWP/269/95 rev. 4
English (EN) (258.92 KB - PDF)
First published: Last updated:
Concept paper on the revision of the note for guidance on plasma-derived medicinal products
Reference Number: EMEA/CHMP/BWP/495530/2006
English (EN) (76.56 KB - PDF)
First published: Last updated:
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)
AdoptedLegal effective date: Reference Number: CPMP/BWP/5180/03
English (EN) (172.04 KB - PDF)
First published: Last updated:
Note for guidance on plasma-derived medicinal products
AdoptedLegal effective date: Reference Number: CHMP/BWP/269/95/ rev. 3
English (EN) (269.88 KB - PDF)
First published: Last updated:
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