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Quality Control01:05

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Quality control is one of the three cyclical quality assurance activities that help keep a system under statistical control. Typical quality control activities include creating quality control charts, conducting proficiency testing, and documenting and archiving results.
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Quality Assurance: Compounding Record Audits for Error Prevention.

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  • 1U.S. Department of Veterans Affairs, Lexington VA Health Care System, Lexington, Kentucky. jessical.hawkins@va.gov.

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Summary
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This study emphasizes proactive auditing of pharmaceutical compounding records to detect and prevent errors. Implementing United States Pharmacopeia standards ensures quality assurance in sterile and nonsterile preparations.

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Area of Science:

  • Pharmaceutical Compounding Quality Assurance
  • Regulatory Compliance in Pharmacies

Background:

  • Pharmaceutical compounding facilities must adhere to stringent record-keeping requirements.
  • The 2022 United States Pharmacopeia (USP) Chapters <795> and <797> outline critical standards for nonsterile and sterile compounding.
  • Inconsistencies in compounding can lead to significant patient safety risks.

Purpose of the Study:

  • To outline a proactive strategy for identifying pharmaceutical compounding inconsistencies at the facility level.
  • To review the record-keeping requirements mandated by USP <795> and USP <797>.
  • To demonstrate how to leverage these requirements for effective quality assurance and error prevention.

Main Methods:

  • Review of master formulation and compounding record requirements from USP <795> and USP <797> (2022).
  • Analysis of strategies for utilizing record-keeping for facility-level auditing and reporting.
  • Integration of audit findings into a comprehensive quality-assurance program.

Main Results:

  • Established a framework for proactive detection of compounding errors through systematic record review.
  • Highlighted the importance of USP <795> and USP <797> compliance for maintaining compounding integrity.
  • Demonstrated the utility of regular audits and reporting in enhancing pharmaceutical quality assurance.

Conclusions:

  • Proactive auditing of pharmaceutical compounding records is essential for error detection and prevention.
  • Adherence to USP <795> and USP <797> standards, coupled with robust quality assurance programs, improves facility-level compounding practices.
  • Implementing regular audits ensures continuous improvement in pharmaceutical compounding safety and efficacy.