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Kastango Consulting Group – GAP Analysis Services

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Facility and General Operational GAP Analysis USP 795, 797, 800, and 825

Our consultants will conduct an onsite, facility operational assessment for compliance with USP Chapters 797 and 800. Up to a two-person team will provide a half-day, onsite visit to review and assess the hospital pharmacy and facility design and perform a facility and general operational gap analysis for compliance with current requirements specified in USP 795 (as it relates to USP 800), USP 797 and USP 800. The consultant’s strategy is to assess the facility for its intended use along with:

• Compounding risk level and general process flow,
• Specific airflow requirements,
• Filter requirements,
• Engineering control requirements,
     • Primary engineering controls (e.g., hoods)
     • Secondary engineering controls (e.g., buffer and ante-room)
• Room pressurization requirements,
• Temperature and humidity requirements,
• Architectural finish requirements.

Current State Operational Assessment

Our consultants will conduct an onsite, facility operational assessment to determine the current state for compliance with USP Chapter 797 and 800 (if applicable). Up to a two-person team will conduct an onsite visit of up to six (6) hours to review and assess the hospital pharmacy, performing an operational assessment for compliance with current requirements specified in USP Chapter 797 and 800 (if applicable). The consultant’s strategy is to assess the facility for its intended use along with:

• Compounding risk level and process flow
• Hand hygiene, garbing, and aseptic technique procedures
• Cleaning, environmental monitoring, and other documented processes required by the chapter.
• Hazardous drug handling (if applicable)