The purpose of this guide is to show how Q.I. Medical products support a pharmacist's goal of complying with USP Chapter 797 compliance documentation. In this case, USP's focus is on specific quality assurance activities involving compounded sterile preparations (CSPs).
According to USP Chapter 797: "The intent of this chapter is to prevent harm and fatality to patients that could result from microbial contamination (nonsterility), excessive bacterial endotoxins, large content errors in the strength of correct ingredients, and incorrect ingredients in CSPs." USP Chapter 797 PDF Download.
USP Chapter 797 Compliance Documentation Cross Reference
Q.I. Medical products target the prevention/detection of microbial contamination and the detection of excessive bacterial endotoxins. Areas addressed are personnel training, evaluation of aseptic manipulations, air and surface quality testing of the compounding environment, sterility testing, and detection of excessive bacterial endotoxins. Please review the list below in order to match up the correct product with the proper section of USP chapter 797 compliance documentation.
USP Chapter 797 puts pharmacy prepared CSPs into 3 categories based on the difficulty of maintaining sterility and potential for patient harm: Low risk, medium risk, and high risk. Refer to the definitions in Chapter 797 to determine which category describes a particular compounding operation. The frequency and complexity of Quality Assurance procedures are driven by the highest risk level. USP <797> describes the minimum USP Chapter 797 compliance procedures that are required, many pharmacies routinely exceed the minimums to increase the patient safety of their CSPs.
A useful tool is the chart at the end of Chapter 797. "Criteria" activities supported by Q.I. Medical test kits include QA Practices, Finished Product-Release Checks and Tests, Processing: Aseptic Technique, Verification Procedures - Sterility Testing, Verification Procedures - Environmental Monitoring, and Verification Procedures - Personnel Training and Education.
JCAHO surveyors will not look for compliance with these requirements. State Boards of Pharmacy may include Chapter 797 in their professional codes. To view USP Chapter 797, see Chapter 797 PDF Download.
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