Download in electronic PDF format for $25



Search the Complete Journal Archives

Quality Assurance and Quality Control, Part 1

Author(s):  Akers Michael J

Issue:  Mar/Apr 2015 - Volume 19, Number 2
View All Articles in Issue

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

Related Categories: STERILE PREPARATIONS, QUALITY CONTROL, UNITED STATES PHARMACOPEIA CONVENTIONS

Printer-Friendly Version

Related Articles from IJPC
Title (Click for Abstract / Details) Author Issue Page View/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
Quality Assurance and Quality Control, Part 1 Akers Michael J Mar/Apr 2015 121-124 Buy
Quality Assurance and Quality Control, Part 2 Akers Michael J May/Jun 2015 215-221 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
Quality-Control Analytical Methods: A Discussion of United States Pharmacopeia Chapter <71> Sterility Tests Kupiec Thomas C Sep/Oct 2007 400-403 Buy
Basics of Compounding: Considerations for Implementing United States Pharmacopeia Chapter <797> Pharmaceutical Compounding--Sterile Preparations, Part 13: Environmental Quality and Control Allen Loyd V Jr, Okeke Claudia C May/Jun 2009 234-238 Buy
Basics of Compounding: Considerations for Implementing United States Pharmacopeia Chapter <797> Pharmaceutical Compounding--Sterile Preparations, Part 6: 2008 Revisions to Chapter <797> Allen Loyd V Jr, Okeke Claudia C Mar/Apr 2008 136-144 Buy
Basics of Compounding: Application of the United States Pharmacopeia Bacterial Endotoxins Test to Compounded Sterile Preparations Dawson Michael F Jan/Feb 2006 36-39 Buy
Microbial Air-Sampling Equipment, Part 1: Meeting United States Pharmacopeia Chapter <797> Standards Kastango Eric S May/Jun 2008 216-229 Buy