Quality and safety of blood products
Biological medicines such as blood products and related in vitro diagnostic tests are life-saving components of every day medical practice worldwide. Although scientific evidence shows that blood products have never been safer since the introduction of several measures in the last years, uncertainty still persists in the public perception of how safe blood components and plasma products are. Particular safety considerations arise from the biological nature of the starting materials used, the manufacturing process involved and the test methods needed to characterize the production consistency.
Harmonization on quality assurance and safety of blood products calls for a quality assurance system based on the existence of a national structure that is independent of the manufacturer and that is responsible for granting licenses for blood products, defining procedures for products release and for post-marketing surveillance systems. In order to avoid transmission of infectious agents, Good Manufacturing Practices (GMP) should be adopted as an essential tool of the quality assurance system. In addition, GMP should be adhered to at all levels of the manufacturing process, from the collection of the source materials to the quality control of the final product, thus ensuring traceability from the donor to the recipient.
The provision of plasma products requires the availability of sufficient plasma of assured quality and safety. Policies for mandatory testing should be determined by the national control authority, and should be reviewed regularly and modified according to the current state of knowledge. Blood/plasma donor selection, collection procedures, testing methods, donation handling, storage and transport of plasma should follow defined quality assurance procedures, the importance of which has been highlighted by international guidelines. Improved single donation and plasma pool testing as well as improved manufacturing methods for purification and virus inactivation have enhanced the safety of blood components and plasma derivatives.
It is a WHO priority to contribute to the advancement of technical expertise of National Regulatory Authorities and the formation of regulatory regional networks so that only blood products of assured quality and safety are used worldwide.
Technical and Regulatory Assistance to National Regulatory Authorities
- WHO Recommendations for the Production, Control and Regulation of Human Plasma for Fractionation
WHO Guidelines on viral inactivation and removal procedures intended to assure the viral safety of human blood plasma products. WHO Technical Report Series (TRS) No. 924, Annex 4 (Adopted by ECBS 2001)
Regulation and licensing of biological products in countries with newly developing Regulatory Authorities. WHO Technical Report Series No 858, Annex 1 (Adopted by ECBS 1994)
WHO Requirements for the collection, processing and quality control of blood, blood components and plasma derivatives. WHO Technical Report Series No. 840, Annex 2 (Adopted by ECBS 1992)
WHO Guidelines for national authorities on quality assurance for biological products. WHO Technical Report Series No 822, Annex 2 (Adopted by ECBS 1991)
WHO Guidelines for assuring the quality of pharmaceutical and biological products prepared by recombinant DNA technology. WHO Technical Report Series No 814, Annex 3 (Adopted by ECBS 1990)
Quality and safety of blood products and related substance, AIDE-MEMOIRE, WHO
Ensuring the Quality and Safety of Plasma Derived Medicinal Products, Information Sheet
Plasma Contract Fractionation Program, Information Sheet
Strengthening National Regulatory Authorities, AIDE-MEMOIRE, WHO (May 2003)
- Eleventh International Conference of Drug Regulatory Authorities (ICDRA); Workshop on Assuring quality and safety of blood products. Madrid, Spain (2004)
- Tenth International Conference of Drug Regulatory Authorities (ICDRA); Workshop on Safety of blood-derived products. Hong Kong, China (2002)
- Ninth International Conference of Drug Regulatory Authorities (ICDRA); Workshop on Safety issues of plasma-derived medicinal products. Berlin, Germany (1999)
Report on WHO Working Group on Biological Standardization of Unfractionated Heparin, Geneva, Switzerland (Sept 1999)