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

The issue of investigation into vaccine files and control in general has always been a delicate one. There are considerable economic and medical interests. The supervisor should not then thwart a step towards progress and should not appear as an economic brake. Yet he should guarantee to the users a certain quality in the marketed biological products. According to these principles, recommendations have been formulated to indicate tests that should be realized by manufacturers and related in files of request for Marketing Authorization. Consequently the level of requirements may seem quite high in France. But partners involved in the investigation of files and in vaccine controls as well as those who are concerned with the marketing of new biological products should guarantee their quality. In addition to investigating the file, controls are undertaken in France by State laboratories which specialize in a particular species. They are also applied research laboratories. These controls aim at checking the manufacturers' results. In France no systematic control is undertaken on successive vaccine batches before marketing. Controls are undertaken at random if information coming from users gives rise to suspicion about a vaccine or batch of vaccines which are causing problems. However systematic controls should be undertaken by a private or State laboratory for imported batches. In future, only control results will probably be required. However batch-to-batch controls are undertaken by a state laboratory for rabies vaccines and tuberculin. In conclusion, in France we favour controls before Marketing Authorization together with high specifications for manufacturers. State batch-to-batch control is not undertaken since present means do not encourage such a procedure, the interest of which are not obvious; furthermore, this procedure remains very restricting for manufacturers.