Gap Analysis/Audit
We will compare your pharmacy operations to USP<797>/<800> requirements and make recommendations to achieve compliance. This is often the most overlooked but most important aspect of a compliance effort. QS will provide a detailed analysis outlining observations, deficiencies and recommendations on how to improve or achieve compliance.
Facility Assessment
We can provide a detailed review of your facility and its related personnel and material workflows to check for compliance with USP<797>/<800>. A detailed report is delivered that lists deficiencies and recommends facility changes.
Facility Design
We can serve as your Owner's Agent on the project team to ensure all engineering controls and facility design elements are built into the project scope during the design process. We will work with your architects and engineers to develop a cleanroom design from a pharmacy workflow and environmental sampling perspective. This approach helps prevent costly design errors that hinder meeting specification after project turnover.
Policies and Procedures
We excel at working with pharmacy management to provide customized policies and procedures based on your pharmacy. We do not sell templates. All policies are written after we have a detailed understanding of facility and workflows.
Deviation Investigation and Root Cause Analysis
We offer deviation investigation services that focus on root cause analysis to create corrective actions for out of specification conditions. We may conduct an onsite evaluation and review all data to make recommendations on cleaning, workflow modifications, and facility renovations.
Hazardous Drug Assessments USP<800>
We will provide a hazard assessment of your facilities and processes related to the transporting, compounding, administering or other handling of hazardous drugs in the pharmacy per USP<800>. We will assist pharmacy management in developing procedures for testing and provide staff training to assess staff's competencies when mixing hazardous drugs.