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

A review is given on the registration procedure and controls of veterinary vaccines in Belgium. An obligatory registration procedure was installed in 1969, and has since been modified several times. The Belgian approach for control of veterinary vaccines before and after registration is explained. Controls before registration are often carried out exclusively by the manufacturer and are described in the registration file. Controls may, however, also be carried out by an independent laboratory if the manufacturer so desires. In general, the procedures described in a national or European Pharmacopoeia must be applied if a monograph is available. Batch control after registration is carried out by the manufacturer. When manufactured in Belgium, controls on the finished product must also be carried out by the Institute of Hygiene for viral vaccines and some selected bacterial vaccines (e.g. anthrax). In addition, all batches of imported vaccines are subject to controls both by an officially accepted laboratory and by the Institute of Hygiene, the first to be paid by the importer, the second free of charge. Batch controls include homogeneity of the batch, labelling, storage conditions and also identity of active component(s), safety, sterility, absence of extraneous agents and potency. The potency test described in the original registration file must be used for batch control.