title: [Official testing of immunological veterinary medicinal products].
abstract: The testing of immunological veterinary medicinal products (IVMPs) by official medicines control laboratories (OMCLs) is an important contribution to the control of quality, safety and efficacy of these products. Based on the legislation of the European Union (EU) and with the support of the European Directorate for the Quality of Medicines & HealthCare (EDQM) a network of OMCLs of the EU member states and Switzerland has been built. This network has established its own rules allowing the mutual recognition of test results and rapid communication of details regarding batch release or rejection. Annual reports, OMCL meetings and collaborative studies help to foster confidence between the OMCLs. The procedure for official testing is described and an overview of deficits found at testing is presented in the paper. The testing of selected batches of centrally authorized products is also performed by OMCLs and is briefly described. Communication both among OMCLs and with pharmaceutical industry is an important part of the OMCLs' work to compare test results and to optimize existing or develop new test methods. Several OMCLs are also pursuing the development of new test methods, primarily for the reduction, refinement and replacement of animal experiments in routine testing.
authors.affiliation: Bundesinstitut für Impfstoffe und biomedizinische Arzneimittel, Paul-Ehrlich-Institut, Paul-Ehrlich Straße 51-59, 63225, Langen, Deutschland, Carmen.Jungbaeck@pei.de.
authors.forename: C
authors.initials: C
authors.lastname: Jungbäck
authors.forename: A
authors.initials: A
authors.lastname: Motitschke
mesh_terms: D000818:Animals; D001688:Biological Products / Q000032:analysis / Q000592:standards*; D004341:Drug Evaluation / Q000331:legislation & jurisprudence* / Q000592:standards; D005060:Europe; D005062:European Union / Q000458:organization & administration; D005858:Germany; D033161:Government Regulation; D007155:Immunologic Factors / Q000032:analysis / Q000592:standards*; D007753:Laboratories / Q000331:legislation & jurisprudence* / Q000592:standards*; D007880:Legislation, Drug; D011358:Product Surveillance, Postmarketing / Q000592:standards*; D019155:Veterinary Drugs / Q000032:analysis / Q000592:standards*
chemical_list: D001688:Biological Products; D007155:Immunologic Factors; D019155:Veterinary Drugs