Sterile Compounding Supervisor Third-Party Evaluation

Designed to support sterile compounding pharmacies in meeting provincial/territorial regulatory authority implemented Sterile Compounding Supervisor third-party evaluations:

The sterile compounding supervisor must be evaluated for knowledge and abilities, at the same frequency as compounding personnel, by a third party (an evaluator with expertise in sterile preparation compounding, at arm's length from the facility/pharmacy and free of any real or perceived conflict with the individual being evaluated).

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., Policies and Procedures, Compounding Records, Master Formulation Records), 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, and preparation for the Media-Fill and Gloved Fingertip tests.

Phase 2 (Visit): Pharmacy-tailored, onsite visit with the consultant for an a-z evaluation of 2 sterile compounding supervisors theoretical and practical competencies based on NAPRA’s model standards implemented as per provincial/territorial regulatory authorities, including the supervisor's ability to apply and oversee aseptic technique compounding and cleaning & disinfecting personnel training programs, written policies and procedures, facility engineering and environmental control management program, risk management protocols, MFR and CR database, among more.

Phase 3 (Post-Visit): A comprehensive written Sterile Compounding Supervisor’s third-party evaluation complete with Findings and Observations on conformance, competency, and compliance in meeting their roles and responsibilities, in support of the provincial/territorial regulatory authority implementation of the Model Standards for Pharmacy Compounding [Non-Hazardous and/or Hazardous] Sterile Preparations.