Abstract

Quality Assurance and Quality Control, Part 2

Author(s): Akers Michael J

Issue: May/Jun 2015 - Volume 19, Number 3

Page(s): 215-221

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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

  • 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

Related Categories

  • LEGAL
  • STERILE PREPARATIONS
  • SUPPORT
  • QUALITY CONTROL
  • UNITED STATES PHARMACOPEIA CONVENTIONS

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