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Quality Assurance and Quality Control, Part 2

Author(s):  Akers Michael J

Issue:  May/Jun 2015 - Volume 19, Number 3
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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 discussion of United States Pharmacopeia <1163>, and advances in pharmaceutical quality systems.

Related Keywords: Michael J. Akers, PhD, compounded sterile preparations, contamination, United States Pharmacopeia Chapter <1163>, United States Pharmacopeia Chapter <797>, USP, quality assurance, sterility testing, bacterial endotoxin testing, pharmaceutical quality sysstems, injectables, drug safety, microorganisms, finished preparation release checks, fluid thioglycollate medium, trypticase soy broth medium, membrane filtration sterility testing, pyrogens, limulus amebocyte lysate test, quality by design


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