Control of product batches (before and after registration). The German approach

At present, batch control is performed after a product is licensed. The range of batch control tests and the detailed description of these tests are fixed for every product during the respective authorization procedure. In an increasing number of cases it also seems necessary to test the prelicensing batches, which are used in the clinical trials for efficacy and safety. The batch control performed in the Paul-Ehrlich-Institute consists of the control of the batch protocols and the practical control of product samples. The practical testing includes purity, efficacy and safety of the batch. Considerable quality differences occur from one batch to another, even when the batch-to-batch-consistency is documented during the authorization procedure. Moreover, without previous indication to the state authority, the authorized control tests are frequently modified by the producer or are not performed for each batch. Some examples of these occurrences are presented. In addition it is necessary to bear in mind that the production of vaccines and sera needs biological seed materials, the quality of which can never be so uniform in the way chemical substances normally are. Since most of the incidents which occur when using vaccines and sera are batch-related and not product-related, the continuous batch control by state authorities is considered to be necessary.