Abstract
Quality Assurance: Compounding Record Audits for Error Prevention
Author(s): Hawkins Jessica
Issue: May/Jun 2023 - Volume 27, Number 3
Page(s): 211-217
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
Related Categories
- LEGAL
- SOPs
- QUALITY CONTROL