title: Quality Assurance and Quality Control, Part 1.
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 represents part 1 of a 2-part article on quality-assurance and quality-control procedures and serves as an introduction to the topic of finished preparation release checks and tests. Part 1 highlights what is required to comply with United States Pharmacopeia General Chapter <797>, and part 2 continues with a discussion on the requirements of <797> as well as what is required in chapter < 1163> with respect to quality assurance of compounded sterile preparations. Written procedures, good documentation practices, and specific details for clarity, sterility, and bacterial endotoxin (pyrogen) testing are presented in this article.
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Akers
mesh_terms: D004339:Drug Compounding / Q000592:standards*; D004731:Endotoxins / Q000032:analysis; D006801:Humans; D011785:Quality Assurance, Health Care; D011786:Quality Control
chemical_list: D004731:Endotoxins