Offical batch control of blood preparations – guaranteeing high safety of plasma derived products for 25 years

Source: pixabay

The implementation of the Regulation was an effective response to the HIV scandal in the 1990s. The Regulation applied from 16 July 1994 to one type of coagulation factors (Factor IX products) and to prothrombin complex concentrates. For all other blood preparations made from blood plasma, the Ordinance entered into force on 01.07.1995 with a one-year transitional period. From this date on, they may be placed on the market after receiving the official batch release from the Paul-Ehrlich-Institut (PEI), Federal Institute for Vaccines and Biomedicines. The first batch release for a prothrombin complex preparation was issued by the PEI on 9 August 1994, shortly after the Regulation entered into force. Since then, the regulation has been an essential node in the network for the safety of products made from blood plasma in Germany.

In 1994, the PEI was given the task of testing and evaluating medicines made from blood. In the following years, the PEI developed numerous measures to increase the safety of these medicinal products and to ensure their future safety. In addition to the official batch testing of blood plasma products, this included, among other things, market cleansing for plasma products, participation in European and international committees and numerous research activities in the field of haematology.

During official batch testing, the quality, efficacy and safety of each batch of plasma-derived products is checked by extensive laboratory testing of samples and by examination of the manufacturing documentation. During the experimental quality test, PEI experts examine the active ingredient content of the product. With the safety test, they test the drugs for harmful impurities. It is also important to test coagulation factor preparations for the absence of activated coagulation factors and fever-causing substances. These could damage the patient. The examination of the manufacturing documentation includes an examination of the plasma origin and compliance with the approved manufacturing model. The origin of the plasma is checked to ensure that only plasma from approved donation centres is used and that all mandatory tests have been carried out. This information is listed in the so-called Plasma Master Files (PMF), which are kept centrally by the European Medicines Agency (EMA). In addition, the plasma pools from which the drugs are made are also subject to government testing to check for the absence of blood-borne viruses that cause diseases such as AIDS or hepatitis.

The PEI is represented as a State Control Laboratory for blood products in the European Network of Official Medicines Control Laboratories (OMCL) organised by the European Directorate for the Quality of Medicines (EDQM) of the Council of Europe. This network was also founded 25 years ago and is thus the procedure for mutual recognition of batch releases within the EU and the European Economic Area.

As a member of the OMCL network, PEI carries out its own experimental tests and issues certificates for other EU member states. However, it also checks and recognises certificates issued by other OMCL members. In recent years, PEI has experimentally tested an average of 1500 batches of blood products and about 2200 plasma pools. There is currently a clear increase, partly due to the upcoming Brexit. The PEI is experimentally testing batches that were previously tested by the British OMCL. In the first six months of this year, the PEI has already tested 880 product batches and 1500 plasma pools.