Quality Assurance and Safety: Blood Products and related Biologicals
Since the middle of the 20th century, medical science has found ways to prepare therapeutic products derived from human blood and plasma for the treatment of many life threatening diseases, as well as for complex surgical procedures.
Processing blood into various types of medicines or products is a highly specialized process because blood products and biological technologies are inherently variable due to the nature of the source materials as well as the methods used to test them. The overall goal of the National Regulatory Authorities is to ensure that only blood products of demonstrated quality, safety and efficacy should be used. Yet, experience with regulatory authorities indicate that many countries have significant difficulties in fulfilling their responsibilities in this field.
WHO is responding to immediate needs by providing technical guidance and quality assurance tools to Medicines Regulatory Authorities, National Control Laboratories and manufacturers to support implementation of quality and safety systems for the production and control of blood products and related in vitro diagnostic devices worldwide.
The development of International Reference Materials and Guidelines to support the technical capacity of National Regulatory Authorities and to assure the compliance of manufacturers to quality and safety measures form the basis of our Mission. These contribute to technology transfer and global harmonization of quality assurance regulations.
Challenges and Issues:
- To strengthen National Regulatory Authorities on quality assurance systems for the control of quality and safety of blood products and in vitro diagnostic devices.
- Need to assure quality and safety of blood and plasma globally to prevent transmission of blood-borne viral diseases via blood products.
- Need to prioritize the development of WHO International Reference Materials of interest in Regions and countries with limited resources.
- To facilitate access to and appropriate use of WHO International Reference Materials by national control laboratories or designated laboratories and manufacturers in developing countries.
- To promote support for the implementation of new manufacturing technologies to avoid viral contamination and other infectious agents via blood products.
- WHO Recommendations for the Production, Control and Regulation of Human Plasma for Fractionation
WHO Guidelines on Tissue Infectivity Distribution in Transmissible Spongiform Encephalopathies (2006)
See Annex 1: Update 2010 (WHO Tables on Tissue Infectivity Distribution in Transmissible Spongiform Encephalopathies)
WHO Guidelines on viral inactivation and removal procedures intended to assure the viral safety of human blood plasma products. Technical Report Series (TRS) No. 924, Annex 4 (Adopted by ECBS 2001)
WHO Guidelines for Thromboplastins and Plasma Used to Control Anticoagulant Therapy. WHO Technical Report Series No 979, Annex 6 (Adopted by ECBS 1997)
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 Technical Report Series (TRS)
WHO Consultation on Global Measurement Standards and their use in the in vitro Biological Diagnostic Field (Jun 2004)
WHO Working Group on International Reference Preparations for Testing Diagnostic Kits used in the Detection of HBsAg and anti-HCV Antibodies (Adopted by ECBS 2003)