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Quality Assurance and Quality Control, Part 1
International Journal of Pharmaceutical Compounding
|December 22, 2015
Summary
Strict adherence to quality assurance and control is crucial in sterile compounding. This article introduces essential procedures for finished preparation release, focusing on United States Pharmacopeia General Chapter <797> compliance.
Area of Science:
- Pharmaceutical Compounding
- Quality Control and Assurance
- Sterile Preparations
Background:
- The New England Compounding Center incident highlighted risks of inadequate quality control in sterile compounding.
- Compounding sterile preparations requires rigorous adherence to quality-assurance and quality-control procedures.
Purpose of the Study:
- To introduce quality-assurance and quality-control procedures for sterile preparations.
- To detail requirements for finished preparation release checks and tests.
- To provide an overview of United States Pharmacopeia (USP) General Chapter <797>.
Main Methods:
- Review of USP General Chapter <797> requirements for sterile compounding.
- Discussion of essential elements for quality assurance in sterile preparation.
- Presentation of specific details for clarity, sterility, and bacterial endotoxin (pyrogen) testing.
Main Results:
- Part 1 of this article focuses on USP <797> compliance for sterile preparations.
- Key components include written procedures and good documentation practices.
- Essential tests involve clarity, sterility, and bacterial endotoxin (pyrogen) analysis.
Conclusions:
- Strict implementation of quality-assurance and quality-control protocols is vital to prevent risks associated with compounded sterile preparations.
- Understanding and applying USP <797> standards is fundamental for safe sterile compounding practices.
- This article serves as a foundational guide for ensuring the quality and safety of compounded sterile preparations.
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