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USP 797 Gap Analysis Date: page 1USP 797 1. INTRODUCTION AND SCOPE: Standards to be followed when preparing compounded sterile human & animal drugs compounded sterile preparations (CSPS). Required
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How to fill out usp 797 gap analysis
How to fill out usp 797 gap analysis
01
To fill out a USP 797 gap analysis, follow these steps:
02
Obtain a copy of the USP 797 guidelines.
03
Review the requirements and recommendations outlined in the guidelines.
04
Assess your current practices and procedures against the guidelines.
05
Identify any gaps or areas of non-compliance.
06
Develop action plans to address each gap or non-compliant area.
07
Prioritize the action plans based on urgency and feasibility.
08
Assign responsibility for implementing each action plan.
09
Set deadlines for completion of the action plans.
10
Monitor progress and track the implementation of each action plan.
11
Regularly review and update the USP 797 gap analysis as new guidelines or recommendations are released.
Who needs usp 797 gap analysis?
01
Any healthcare facility or pharmacy that handles sterile compounding needs a USP 797 gap analysis.
02
This includes hospitals, pharmacies, compounding centers, and other healthcare settings.
03
The analysis helps ensure compliance with the USP 797 guidelines and promotes patient safety by identifying areas where improvements are needed.
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What is usp 797 gap analysis?
USP 797 gap analysis is an assessment tool used to evaluate a facility's compliance with the United States Pharmacopeia (USP) guidelines for sterile compounding. It identifies areas where practices may not meet the standards set forth in USP 797.
Who is required to file usp 797 gap analysis?
Healthcare facilities and pharmacies that engage in sterile compounding are required to file a USP 797 gap analysis to ensure compliance with the standards for the preparation of sterile medications.
How to fill out usp 797 gap analysis?
To fill out a USP 797 gap analysis, stakeholders should conduct a thorough review of their current practices, compare them against USP 797 standards, document any discrepancies, and outline action plans to address any identified gaps.
What is the purpose of usp 797 gap analysis?
The purpose of the USP 797 gap analysis is to ensure that facilities are adhering to the required standards for sterile compounding, minimizing the risk of contamination and ensuring patient safety.
What information must be reported on usp 797 gap analysis?
The information that must be reported on the USP 797 gap analysis includes a summary of existing practices, identified gaps in compliance, potential risks, and a plan for correction to align with USP 797 requirements.
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