USP 797 and USP 800 Clean Room Audit
Industry
Clinic Pharmacy
Problem
A healthcare company was starting a home infusion pharmacy service. Because the healthcare technology company does not own a pharmacy, an agreement was reached to share a clean room with a partner health system. The healthcare company was concerned about the regulatory challenges and requirements associated with starting such a complex operation.
PHSL Solutions
PHSL held discussions with management, created an audit plan, reviewed the organization’s policies and procedures, identified gaps in the policies and procedures, and offered solutions to remedy the identified gaps. PHSL then conducted an on-site audit to assess the pharmacy’s layout and operations against the rules of USP 797 and 800, as well as state pharmacy regulations. PHSL provided the healthcare company with a comprehensive report highlighting areas of concern, levels of risk, and recommendations to achieve compliance.
Results
The gap analysis, audit findings, and action plan highlighted the issues that pharmacy management should address before launching their service, allowing them to better focus their efforts on meeting their launch date while potentially avoiding audit or patient safety risks in the future.