Quality Assurance: Compounding Record Audits for Error Prevention
Author(s): Hawkins Jessica
Issue: May/Jun 2023 - Volume 27, Number 3
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Page(s): 211-217
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Abstract: This article looks at taking a proactive approach in discovering inconsistencies in pharmaceutical compounding at a facility level. Details on the requirements for master formulation and compounding records in nonsterile and sterile compounding as laid out in the 2022 publications of United States Pharmacopeia Chapter <795> Pharmaceutical Compounding— Nonsterile Preparations and United States Pharmacopeia Chapter <797> Pharmaceutical Compounding—Sterile Preparations are reviewed. Following this summary, information is then presented on how to utilize the record-keeping requirements to a facility’s advantage through regular auditing and reporting and how to incorporate these audits or reports into a facility’s quality-assurance program to fulfill error detection and prevention requirements.
Related Keywords: quality assurance, master formulation records, compounding documentation, United States Pharmacopeia Chapter <795>, United States Pharmacopeia Chapter <797>, error prevention, error detection, compounding record auditing, compounded nonsterile preparations, compounded sterile preparations, compounding record template, audit summary reports