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Basics of Sterile Compounding. Quality Assurance and Quality Control: Being Prepared for U.S. Food and Drug Administration Inspections and Staying in Compliance with United States Pharmacopeia Chapter <797>: Part 2

Author(s):  Martin Matt

Issue:  Nov/Dec 2018 - Volume 22, Number 6
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Abstract:  Compounders engaged in making sterile preparations need to employ a quality-assurance system of documented policies and procedures to attempt to reduce the possibility of contamination. The quality-assurance program will be monitored through the facility’s quality-control system. Compounders should be aware of the requirements of each state they are licensed in as well as the inspection observations commonly noted in 483s issued by the U.S. Food and Drug Administration. Part 1 of this 2-part article discussed the currently evolving regulatory environment and why sterile compounding requires planning and monitoring to deliver quality compounds to patients. Part 2 examines the United States Pharmacopeia’s discussion on the principles of quality assurance and quality control in sterile compounding.

Related Keywords: Matt Martin, PharmD, United States Pharmacopeia Chapter <797>, USP, quality assurance, quality control, United States Pharmacopeia Chapter <71>, sterility testing, compounded sterile preparations, sterile compounding, disinfection, compounding environment, air quality testing, protective garments, visual inspection, particulate matter, cleanroom environment, United States Pharmacopeia Chapter <1116> Microbiological Control and Monitoring of Aseptic Processing Environments, microbial contamination, sterilization, media fill, microorganisms

Related Categories: ENVIRONMENTAL , LEGAL, STERILE PREPARATIONS, QUALITY CONTROL, UNITED STATES PHARMACOPEIA CONVENTIONS, PROFESSIONAL ISSUES

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