Quality of therapeutic plasma—requirements for marketing authorization

Author:

Heiden Margarethe,Seitz Rainer

Publisher

Elsevier BV

Subject

Hematology

Reference29 articles.

1. European Pharmacopoeia Monograph: Human plasma (pooled and treated for virus inactivation), 01/2002:1646, pp. 1323–5.

2. Council Recommendation of 29 June 1998 on the suitability of blood and plasma donors and the screening of donated blood in the European Community. (98/463/EC). Official Journal of the European Communities, L 203/14, 21.07.1998.

3. Note for Guidance on Plasma Derived Medicinal Products, CPMP/BWP/269/95, rev.3 (http://www.emea.eu.int/).

4. Guideline of the European Network of Official Medicine Control Laboratories (OMCL): Official Control Authority Batch Release of Solvent Detergent (SD) Plasma PA/PH/OMCL (2000) 28. (http://www.pheur.org).

5. Recommendation No. R (95)15 on the preparation, use and quality assurance of blood components, Council of Europe,2001

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