title: Quality Assurance and Quality Control, Part 2.
abstract: The tragedy surrounding the New England Compounding Center and contaminated steroid syringe preparations clearly points out what can happen if quality-assurance and quality-control procedures are not strictly practiced in the compounding of sterile preparations. This article is part 2 of a two-part article on requirements to comply with United States Pharmacopeia general chapters <797> and <1163> with respect to quality assurance of compounded sterile preparations. Part 1 covered documentation requirements, inspection procedures, compounding accuracy checks, and part of a discussion on bacterial endotoxin testing. Part 2 covers sterility testing, the completion from part 1 on bacterial endotoxin testing, a brief dicussion of United States Pharmacopeia <1163>, and advances in pharmaceutical quality systems.
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Akers
mesh_terms: D001207:Asepsis / Q000592:standards*; D001431:Bacteriological Techniques / Q000592:standards; D002626:Chemistry, Pharmaceutical / Q000592:standards; D004339:Drug Compounding / Q000592:standards*; D004340:Drug Contamination / Q000517:prevention & control*; D004731:Endotoxins / Q000009:adverse effects / Q000032:analysis*; D019983:Guideline Adherence / Q000592:standards; D017408:Guidelines as Topic / Q000592:standards*; D006801:Humans; D061214:Patient Safety; D004364:Pharmaceutical Preparations / Q000032:analysis / Q000592:standards*; D011749:Pyrogens / Q000032:analysis; D011786:Quality Control; D019984:Quality Indicators, Health Care / Q000592:standards*; D012307:Risk Factors; D013678:Technology, Pharmaceutical / Q000379:methods / Q000592:standards*
chemical_list: D004731:Endotoxins; D004364:Pharmaceutical Preparations; D011749:Pyrogens