Quality Control: Minor Chapters, Major Impacts: What United States Pharmacopeia Chapters <51>, <61>, <62>, and <1207> Mean for Your Compounding Practice
Author(s): Kelley Brian
Issue: Mar/Apr 2021 - Volume 25, Number 2
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Page(s): 115-124
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Abstract: The United States Pharmacopeial Convention, Inc. recommends within the standards of the United States Pharmacopeia that compounding pharmacies have staff dedicated to quality assurance and quality control to ensure patients are receiving safe medications. The quality-control program must include testing. While compounding pharmacies have grown familiar with potency, sterility, and endotoxin testing, there are many more tests recommended within the United States Pharmacopeia that are critical for evaluating the quality of compounded preparations. This article discusses when a few of these tests should be utilized, how to assign acceptance criteria, and how test results are obtained.
Related Keywords: Brian Kelley, BS, United States Pharmacopeia Chapter <51>, United States Pharmacopeia Chapter <61>, United States Pharmacopeia Chapter <62>, United States Pharmacopeia Chapter <1207>, United States Pharmacopeial Convention, drug safety, quality control, quality assurance, microbial testing, microbiological quality, microbial enumeration testing, testing for specified organisms, antimicrobial effectiveness testing, package integrity testing -- sterile products, acceptance criteria, pharmaceutical preservatives, compounded sterile preparations, container closure integrity
Related Categories: EXCIPIENTS, QUALITY CONTROL, UNITED STATES PHARMACOPEIA CONVENTIONS