title: Laboratory considerations of United States Pharmacopeia Chapter <71> sterility tests and its application to pharmaceutical compounding.
abstract: The purpose of this article is to describe United States Pharmacopeia Chapter <71> Sterility Tests from the perspective of Current Good Manufacturing Practices in order to aid compounding pharmacists in understanding the details and complexities that are required. Compounding pharmacists face a unique challenge in the industry today, with their compounding practice and the U.S. Food and Drug Administration trying to impose Current Good Manufacturing Practices guidelines. Naturally, this becomes a challenge to contract testing laboratories as well, as they are caught between the testing for non-Current Good Manufacturing Practices compounding standards and Current Good Manufacturing Practices manufacturing. It is important that the compounding pharmacist and their partner testing laboratory work closely together to ensure appropriate requirements are being met.
authors.forename: Tiffany D
authors.initials: TD
authors.lastname: Hyde
mesh_terms: D004339:Drug Compounding / Q000592:standards*; D004340:Drug Contamination / Q000517:prevention & control*; D019983:Guideline Adherence; D017408:Guidelines as Topic; D006801:Humans; D061214:Patient Safety; D004364:Pharmaceutical Preparations / Q000032:analysis / Q000592:standards*; D010602:Pharmacopoeias as Topic / Q000592:standards*; D011786:Quality Control; D013242:Sterilization / Q000592:standards*; D014481:United States
chemical_list: D004364:Pharmaceutical Preparations