Quality Assurance and Quality Control, Part 2

Int J Pharm Compd. 2015 May-Jun;19(3):215-21.

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.

Publication types

  • Review

MeSH terms

  • Asepsis / standards*
  • Bacteriological Techniques / standards
  • Chemistry, Pharmaceutical / standards
  • Drug Compounding / standards*
  • Drug Contamination / prevention & control*
  • Endotoxins / adverse effects
  • Endotoxins / analysis*
  • Guideline Adherence / standards
  • Guidelines as Topic / standards*
  • Humans
  • Patient Safety
  • Pharmaceutical Preparations / analysis
  • Pharmaceutical Preparations / standards*
  • Pyrogens / analysis
  • Quality Control
  • Quality Indicators, Health Care / standards*
  • Risk Factors
  • Technology, Pharmaceutical / methods
  • Technology, Pharmaceutical / standards*

Substances

  • Endotoxins
  • Pharmaceutical Preparations
  • Pyrogens