The PMAP will progress as a continual improvement effort until such time that sufficient experience has been gained to evaluate the activity. FDA and HC will jointly assess the lessons learned during the pilot to identify best practices and areas for improvement in the conduct of multipurpose audits/inspections. It is anticipated that the results of the PMAP will be initially assessed once ten multipurpose audits/inspections have taken place under the pilot.
Because multipurpose audits/inspections are intended to satisfy different quality management system requirements, key indicators of success may include:
- The level of manufacturer and AO participation; and
- The ability of AOs to demonstrate that their pre-audit/inspection planning, documentation review, on-site assessment, and audit/inspection reporting still conforms to FDA AP and HC CMDCAS program requirements.
- FDA and HC will provide feedback, where appropriate, to the AO in order to improve their procedures and performance.
The results of an audit/inspection performed under the pilot phase will not influence the eligibility of the manufacturer to participate in latter phases of the Multipurpose Audit Program. In addition, manufacturers who did not participate in the pilot are free to participate at a later date and will not be faced with any restrictions.
