Sterile Designated Person Appraisal

Segmented into 3 phases that allow a comprehensive and tailored approach.

Phase 1 (Pre-Visit): A guided walkthrough on preparatory work required by the pharmacy, including consolidating and preparing all documents to be evaluated (e.g., SOPs, CRs, MFRs), completion of a questionnaire to better understand the pharmacy's specific practice, providing cleaning and compounding schedules so the consultant can work around the pharmacy schedule, and preparation for the Garbing and Gloved Fingertip and Thumb Sampling and Media-Fill Test to assess aseptic technique.

Phase 2 (Visit): Pharmacy-tailored, onsite visit with the consultant for an a-z evaluation of the sterile designated person’s theoretical and practical competencies based on USP requirements, including their ability to apply and oversee aseptic technique compounding and cleaning & disinfecting personnel training programs, written standard operating procedures, facility engineering and environmental control management program, risk management protocols, MFR and CR database, among more.

Phase 3 (Post-Visit): A comprehensive written appraisal of the sterile designated person’s performance; including Findings and Observations on conformance, competency, and compliance in meeting their roles and responsibilities, in support of meeting USP <797> and USP <800> requirements.