USP 797, 795, 800, 825 Gap Analysis
A gap analysis may focus on a specific practice challenge or can be focused on overall facilities and practice in both sterile and nonsterile, hazardous and nonhazardous compounding as well as radiopharmaceutical compounding. Common requests include:
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Operational Evaluation: Measure your organization's compliance with regulatory standards (USP or specific requirements of state law or accreditation ) recommending specific areas of focus for planning, education, and change.
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Compounding Facilities Evaluation: Assess current compounding facilities recommending changes to ensure compliance with regulation and/or "future-proofing" for organizational expansion.
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Onsite feedback and written report provided to help the client with solutions to non-compliant elements.