Bot Detector
IJPC Seal
Download FREE Sample Issue or Article
LEARN MORE
Subscribe Today
A subscription to IJPC includes a print copy delivered by postal mail and on-line access to electronic PDF copies of your subscribed issues.

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
View All Articles in Issue

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

Printer-Friendly Version




Download in electronic PDF format for $45

Related Articles from IJPC
Title (Click for Abstract / Details) Author Issue Page View/Buy
Quality Control: Minor Chapters, Major Impacts: What United States Pharmacopeia Chapters <51>, <61>, <62>, and <1207> Mean for Your Compounding Practice Kelley Brian Mar/Apr 2021 115-124 Buy
PreScription: Formal Appeals to United States Pharmacopeia Regarding USP Chapters <795>,<797>, and <825>: Part 1 Allen Loyd V Jr Mar/Apr 2020 92 Buy
PreScription: Formal Appeals to United States Pharmacopeia Regarding USP Chapters <795>, <797>, and <825>: Part 2 Allen Loyd V Jr May/Jun 2020 180 Buy
Basics of Compounding: Implementing United States Pharmacopeia Chapter <1163> Quality Assurance in Pharmaceutical Compounding, Part 1 Allen Loyd V Jr Mar/Apr 2012 146-150 Buy
PreScription: United States Pharmacopeia Chapter <800> Comments and Alternatives Allen Loyd V Jr May/Jun 2017 180 Buy
United States Pharmacopeia Chapter <797> Timeline: 1989 to 2013 Newton David W Jul/Aug 2013 283-288 Buy
Performing a United States Pharmacopeia Chapter <800> Compliant Assessment of Risk Cabaleiro Joe Jan/Feb 2020 21-27 Buy
Update on the Proposed Revision Process for United States Pharmacopeia Chapter <797> Pharmaceutical Compounding--Sterile Preparations Okeke Claudia C Jul/Aug 2007 302-305 Buy
Considerations for Implementing United States Pharmacopeia Chapter <797> Pharmaceutical Compounding--Sterile Preparations, Part 3: Risk Levels Allen Loyd V Jr, Okeke Claudia C Sep/Oct 2007 404-410 Buy
Basics of Compounding: Implementing United States Pharmacopeia Chapter <795> Pharmaceutical Compounding--Nonsterile Preparations, Part 3 Allen Loyd V Jr Nov/Dec 2011 488-496 Buy