title: Vaccine industry perspective of current issues of good manufacturing practices regarding product inspections and stability testing.
abstract: I address 2 important topics of current good manufacturing practices as they apply to vaccine products: product inspections and stability testing. The perspective presented is that of regulated industry. There are 2 major categories of product/facility inspections: those occurring before licensure of a vaccine product and those occurring after a vaccine product is licensed. The logistics and focus of each inspection type, the preapproval inspection, and the required biennial inspection are discussed, as are guidance and recommendations for achieving successful inspections. The requirements, guidance, and recommendations regarding the type, amount, and extensiveness of stability data for vaccine products are presented. The discussion details the potential differences in the amount and type of data required for products that are not yet licensed versus marketed products. Guidance, from a regulated industry perspective, regarding the design and implementation of a successful stability program is also discussed.
authors.affiliation: Wyeth-Lederle Vaccines, Pearl River, NY 10965, USA. monahat@labs.wyeth.com
authors.forename: T R
authors.initials: TR
authors.lastname: Monahan
mesh_terms: D017277:Drug Approval; D004353:Drug Evaluation, Preclinical; D004345:Drug Industry / Q000592:standards; D004355:Drug Stability; D005161:Facility Regulation and Control; D006801:Humans; D013678:Technology, Pharmaceutical; D014481:United States; D014486:United States Food and Drug Administration; D017778:Vaccines, Combined / Q000592:standards*
chemical_list: D017778:Vaccines, Combined