Meeting on Development of Harmonization of QA system for Blood Products in Asian Countries, SEARO (2004)
Bangkok, Thailand; 31 October – 2 November 2004
Blood products such as albumin, immunoglobulin and clotting factors are produced in many countries, not only for domestically use, but also for export. The human plasma raw material used for blood product production in some countries is collected by blood donation within the country or imported. Due to vCJD and BSE transmission by human blood in some particular areas as well as blood can harbor a number of different viruses, such as various types of hepatitis and HIV infection, the risk of these viruses contamination by blood products and blood components has been reported. Therefore, the quality of source material plays one of important role in determining the quality of the products. Moreover, extreme care should be taken to cover all stages in processing, from blood collection, separation of blood components, in-process control to the quality control of finished products.
Some countries in Asia, such as China and Korea produce a large number of blood products. In addition, some countries such as India and China have a huge amount of source materials for blood product production. Therefore, their QA system in assuring the quality and safety of their blood and blood products is important to other countries as well. Japan is one of blood products producing countries that sometimes import the source materials from other countries; therefore, they have established a good system for assuring the quality of blood products. Moreover, European Union has also a good system and network on this matter.
In Thailand, most of marketed products are imported. Only a few of products are produced for domestically used including blood components. Voluntary blood donation provides abundant source materials. Meanwhile many cases of HIV have been reported and contamination of HIV by blood transfusion has been founded. As National Control Laboratory (NCL), the Division of Biological Products (DBP) is responsible for their quality concerning the safety and efficacy of both locally made and imported products. From our experiences, we found that besides lacking an appropriate technique to determine some of contaminating agents in blood that caused deleterious effect to human, the QA system of some countries are different from others. This causes us difficulties in assuring the quality and safety of the blood products.
In order to have the blood products with a good quality and safety at the same standard, harmonization of the quality system among Asian countries should be established.
- To initiate harmonization of quality assurance system for blood products.
- To harmonize the quality assurance system between Thailand and other Asian countries.
- To initiate NCL networking for assuring the quality and safety of blood products among Asian countries.