Dr Christian Schäerer, Switzerland
The national regulatory authority of Switzerland, Swissmedic, is responsible for the enforcement of the Federal Law on Therapeutic Products, including blood, blood components and blood products.
Controls on stable blood products are similar to those for drugs. For labile blood products, an establishment licence must have been obtained, and quality assurance and GMP ensured for all steps and all quality aspects. For blood and plasma products, specific factors that need to be considered include donor suitability, blood or plasma collection, tests to be performed, preparation, labelling and release processes, etc.
Plasma is a unique biological starting material and traceability is the key to safety. There must be an effective information system between the plasma supplier, the testing laboratory and the fractionators. GMP requirements should cover all stages leading to the finished product. In addition, blood or plasma used as source material should be collected by establishments and tested in laboratories that are subject to inspection and approval by a competent national regulatory authority.
A national regulatory authority should enforce compliance with GMP and the implementation of licensing and inspection systems for blood and plasma collection centres. The use of international standards will further promote harmonization and facilitate regional collaboration and information exchange.