The laboratory animal in quality control of pharmaceuticals

As soon as medicines have get a marketing authorisation,they are controlled by manufacturers and Health Authorities. In France, the Agence du Medicament is in charge of the quality control of medicinal products for human use. Three parameters have to be taken into account : qualitative and quantitative conformity to the formula, evaluation of non toxicity (security controls) and quantification of activity. The two last points are animal large consumers. All these tests are in accordance with registration files, Pharmacopoeias, WHO recommendations for biological substances and guidelines for European Batch Release Procedure.