[Quality assurance in transfusion medicine from an international viewpoint].

International, European and National laws and guidelines require to establish a Quality Assurance System for manufacturers and distributors of drugs. This includes all departments involved in manufacturing, quality control and distribution. On the basis of validated written Standard Operation Procedures and documentation of all single processes a high standard for the safety of drugs is achieved. In addition, retracing from the finished product lot and the customer back to raw materials and suppliers is possible.