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Quality-Control Analytical Methods: Microbial-Testing Aspects of USP Chapter 797 for Compounded Sterile Preparations.
1Analytical Research Laboratories, Inc., Oklahoma City, Oklahoma.
International Journal of Pharmaceutical Compounding
|August 9, 2013
Summary
United States Pharmacopeia (USP) Chapter 797 provides sterile pharmacy compounding standards. This article clarifies USP 797
Area of Science:
- Pharmaceutical Compounding Standards
- Sterile Preparation Quality Control
- Regulatory Compliance in Pharmacy
Background:
- United States Pharmacopeia (USP) Chapter 797, established in 2004, sets the first national standards for sterile pharmacy compounding.
- These standards are also recognized as practice expectations by the Joint Commission on Accreditation of Healthcare Organizations.
- USP 797 broadens regulatory scope, defining practices for environmental control, accuracy, sterility, training, and post-preparation quality assurance.
Purpose of the Study:
- To elucidate the criteria within USP Chapter 797 concerning finished-product testing.
- To provide a clear understanding of microbial testing requirements, specifically sterility testing (USP Chapter 71) and endotoxin testing (USP Chapter 85).
Main Methods:
- Review of United States Pharmacopeia (USP) Chapter 797 guidelines.
- Analysis of specific requirements for sterility testing (USP Chapter 71).
- Examination of endotoxin (pyrogen) testing criteria (USP Chapter 85).
Main Results:
- USP Chapter 797 mandates comprehensive finished-product testing for sterile compounded preparations.
- Key testing includes microbial assessments for sterility and endotoxin levels.
- Adherence to USP Chapters 71 and 85 is crucial for meeting USP 797 requirements.
Conclusions:
- Understanding USP Chapter 797 finished-product testing is essential for ensuring the safety and efficacy of sterile compounded medications.
- Compliance with sterility and endotoxin testing protocols is a critical component of USP 797.
- This guidance supports healthcare professionals in meeting regulatory expectations for sterile compounding.
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