title: Inspection of veterinary biologics in the United States.
abstract: Inspection of veterinary biologics in the United States (U.S.) has changed significantly over the years since the Virus-Serum-Toxin Act (V-S-T) was passed by the U.S. Congress in 1913. At first, government inspectors were appointed to every production location, observing the preparation, testing and initial shipment of veterinary biologics. In the 1950s, a new plan was developed to provide a more scientific basis of inspection. Over a 10-year period, a programme to test finished products at the National Veterinary Services Laboratories and a new procedure for inspecting facilities and products was implemented. Our current programme retains our extensive pre-licensing review of products, labeling, facilities and personnel and adds the new inspection system of random checking of finished batches, unannounced in-depth inspections, control of product batches and post-licensing monitoring. This combination of activities ensures that pure, safe, effective and economical veterinary biologics are available for use in the U.S.
authors.affiliation: USDA/APHIS, Ames, IA 50010.
authors.forename: D C
authors.initials: DC
authors.lastname: Randall
mesh_terms: D000818:Animals; D001688:Biological Products / Q000592:standards*; D006077:Government Agencies; D007880:Legislation, Drug; D007886:Legislation, Veterinary; D011786:Quality Control; D014481:United States
chemical_list: D001688:Biological Products