title: Control of product batches (before and after registration). The British approach.
abstract: In the United Kingdom, some pre-registration testing of immunological products is carried out. However, this is normally not extensive. Usually the tests are laboratory tests undertaken to verify results obtained by the manufacturer or quality controller. For many years, routine post-registration testing of batches of immunological products has been carried out. However, this has ceased and had been replaced by a new system known as the Quality Assurance/Quality Control (QA/QC) scheme. The new scheme is designed to provide the Veterinary Medicines Directorate (VMD) with assurance of the continuing quality of batches of immunological products. The basis of the scheme is a system of inspection of companies' quality control facilities and procedures, every eight months, by staff with appropriate microbiological qualifications and experience. Before an inspection is carried out, the company must provide detailed documentation on the facilities and the quality control procedures used for each product. This provides the inspector with the background information for the inspection and discussions with the company.
authors.affiliation: Veterinary Medicines Directorate, Weybridge, UK.
authors.forename: A M
authors.initials: AM
authors.lastname: Lee
mesh_terms: D000818:Animals; D001688:Biological Products / Q000592:standards*; D004345:Drug Industry / Q000592:standards; D008004:Licensure; D011786:Quality Control; D006113:United Kingdom; D014730:Veterinary Medicine
chemical_list: D001688:Biological Products