Our experienced consultants will compare pharmacy operations to USP<797> and make recommendations in order to achieve compliance. This is often the most overlooked and at the same time, most important aspect of a Pharmacies compliance effort. QS will provide a detailed analysis and report outlining observations, deficiencies and recommendations on how to improve compliance. Reports are written so they can be used as an action plan to correct deficiencies. Each report is customized for your facility. No generic templates or standardized checklists are used.
Quality Solutions can serve as your Client Agent to assist in the engineering controls and facility design elements that are required to achieve compliance and improve workflows. QS works with your architects and engineers to consider the design and pharmacy performance from a pharmacy workflow, and environmental sampling and monitoring perspective. Therefore, a comprehensive Quality Approach helps prevent design errors that hinder meeting specification when conducting environmental monitoring and sampling.
Policies and Procedures
Quality Solutions excels at working with pharmacy management to provide customized policies and procedures based on your specific pharmacy. We do not sell templates. All policies are written after we have a detailed understanding of pharmacy facilities and workflows.
Deviation Investigation and Root Cause Analysis
QS offers deviation investigation services that focus on root cause analysis to create corrective actions for recurring out of specification conditions in your pharmacy. Drawing from microbiological data, excursion reporting and onsite evaluations, QS can make recommendations to cleaning, workflows and facility enhancements that can address excursions and out of specification conditions.
Hazardous Drug Assessments
Our experienced consultants 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. We will assist pharmacy management in developing procedures, provide staff training to recognize hazards and assess staff's competencies when mixing hazardous drugs. QS can also recommend appropriate environmental and surface testing for hazardous drugs as stipulated in USP<797> and assist in developing remediation activities/action plans.
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