title: Assessing risks of changing sterile drug manufacturing sites.
abstract: This article summarizes a recently completed research assignment conducted on behalf of the Food and Drug Administration's (FDA) Office of Pharmaceutical Science. The assignment addressed the issue of changing sterile drug manufacturing sites from the point of view of both synthetic and biotech drug products. The article is intended to provide readers with an overview of the assignment and to summarize a recommended approach whereby the use of a comparability protocol can satisfy the FDA's review expectations on the one hand, and facilitate streamlined compliance and faster product to market by manufacturers on the other.
authors.affiliation: Senior Microbiology Reviewer, Office of Pharmaceutical Science.
authors.forename: Stephen E
authors.initials: SE
authors.lastname: Langille
authors.forename: Cliff
authors.initials: C
authors.lastname: Campbell
mesh_terms: D003132:Commerce; D003257:Consumer Product Safety; D004345:Drug Industry; D006801:Humans; D004364:Pharmaceutical Preparations; D018570:Risk Assessment; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D004364:Pharmaceutical Preparations