Batch Testing (Human)
Official batch testing of allergens, blood plasma-derived products, immunoglobulins and vaccines is an essential task of the Paul-Ehrlich-Institut (PEI).
Pursuant to Section 32 of the German Medicines Act (AMG), the PEI is required to release each batch (production unit) of these medicines before placing them on the market in Germany. The institute reviews the submitted manufacturing documents and the results of the quality controls. It also examines the samples of the batches produced. The PEI will issue the batch release only if the quality, efficacy and safety criteria specified in the marketing authorisaton of the medicinal product are met. The national release notification allows the pharmaceutical company to market the batch of a medicine in Germany.
The experimental testing and release of the batches is carried out pursuant to the procedures and regulations of the official drug control laboratories (OMCL) of the Member States of the European Union (EU) or the European Economic Area (EEA), respectively, or Switzerland. In Germany, this can be done either by the PEI or another OMCL. The OMCLs have joined forces in a network coordinated by the European Directorate for the Quality of Medicines and Health Care (EDQM).
An exemption from official batch testing pursuant to Section 32 paragraph 4 AMG is possible if the manufacturing and control methods of the manufacturer have reached a stage of development in which the required quality, efficacy and safety are guaranteed.
Special rules apply to official batch testing of medicines traded in parallel (imported or distributed in parallel).
In addition to the experimental testing for official batch release, PEI also carries out testing on batches of medicines and intermediate products intended for marketing outside Germany, and issues EU-certificates and test reports for this purpose:
- EU certificates
- Test reports
- WHO certificates.