WHO Regional Consultation for Quality Assurance, and Safety of Plasma and Plasma Derivatives, EMRO (2005)
Cairo, Egypt; 31 January – 3 February 2005
Regional Director’s Message
Honorable Guests, Dear Colleagues, Ladies and Gentlemen,
Welcome to Cairo, City of culture and heritage. It is a pleasure to invite you to this consultation on this newly discussed subject in the region.
Blood components and plasma derivatives continue to be essential for clinical treatment and preventive medicine, despite the availability of alternatives such as recombinant products. This requires a commitment from the transfusion organizations and plasma manufacturers to meet regulatory criteria for optimal quality and safety products. Although scientific evidence shows that blood products have never been safer since the introduction of several measures in the last few years, uncertainty still persists in the public perception of how safe blood components and plasma products are.
Harmonization on quality assurance and safety of blood products calls for quality assurance systems based on the existence of a national structure that is independent of the manufacturer and that is responsible for granting licenses for blood products and establishments, defining procedures for product release and for setting up a post-marketing surveillance system. In order to avoid transmission of infectious agents in a reliable manner, 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 material to the quality control of the final product, thus ensuring traceability from the donor to the recipient.
Ladies and Gentlemen,
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 together with the improvement of manufacturing methods for purification and virus inactivation have enhanced the safety of blood components and plasma derivatives.
Progress made in the last 10 years in protein purification and viral inactivation treatments now makes it possible to manufacture safe and well-tolerated plasma products with a high degree of confidence. Countries with limited resources must benefit from the information and experience already gained in developed countries.
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.
In this consultation, the theme aims at assisting countries with upgrading facilities and fractionation procedures when already existing fractionation programs are primitive, need to achieve improved product yields. The areas discussed will include:
- Fractionation technology for the production of plasma derived products.
- Contrast fractionation alternatives for developing countries.
- Education and training for several technical purposes.
- Assist & upgrade existing fractionation facilities.
- Help in decisions of developing countries for accessibility of safe blood products.
Ladies and Gentlemen,
I hope you enjoy your consultation and look forward to Plans of Action, resulting from your deliberations and discussions. Good luck and once again welcome to Cairo and to the Regional Office for the Eastern Mediterranean.