(2002; 166 pages)
Plasma-derived medicinal products, as well as blood and blood components, should be regulated in the same way as other biological products and fall under the responsibility of regulatory authorities.
The importance of good manufacturing practice (GMP) was emphasized. The main problem identified was how best to minimize the risk of transmitting currently known and emerging blood-borne diseases. Developing countries in particular, had difficult choices to make in planning balanced regulatory action.
1. WHO should promote the regulation of blood and plasma collection centres, with emphasis on ensuring GMP compliance.
2. Regional co-operation and training should be promoted and WHO should facilitate the development of educational programmes and training opportunities for staff involved in regulation and control of blood products.
3. WHO should collaborate with Member States to strengthen the technical expertise of regulatory authorities (especially those countries with plasma fractionation activities/facilities) to assure adequate quality, safety and efficacy of plasma products. Special emphasis should be placed on viral testing, viral inactivation procedures, and surveillance for viral and other transfusiontransmitted diseases. Special attention should be given to the possible risk of transmission of vCJD and appropriate validation studies should be carried out.
4. In those countries where contract fractionation of plasma is a common option, WHO should develop guidance on the regulatory issues involved.
5. In order to facilitate approval by regulatory authorities of importation of plasma products, WHO should promote the use of batch release certificates, with a clear description of the procedures used.
6. Progress should be reported back to the ICDRA.