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Quality Assurance and Quality Control, Part 1

Author(s):  Akers Michael J

Issue:  Mar/Apr 2015 - Volume 19, Number 2
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Note:  Electronic version includes supplemental material.

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.

Related Keywords: Michael J. Akers, PhD, quality management, quality standards, United States Pharmacopeia Chapter <797>, finished preparation release checks and tests, United States Pharmacopeia Chapter <1163>, compounded sterile preparations, practices and procedures, documentation, bacterial endotoxin testing, pyrogen testing, cleaning, disinfection standards, protective clothing and equipment, visual inspection, media-fill testing, standard operating procedures, sterilization, environmental control, in-process checks, compounding procedures


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