FDA now also assesses Countries and Regions as a Risk Factor

Recommendation

13/14 December 2023
Berlin, Germany

Root Cause Analysis
A CAPA Workshop on Successful Failure Investigation

The US Food and Drug Administration (FDA) has updated one of its Manual of Policies and Procedures (MAPP) for staff. The revision of the previous MAPP, "Understanding CDER's Risk-Based Site Selection Model" (5014.1 Rev. 1), details how the FDA will prioritise inspections under the Site Selection Model (SSM). The update adds a risk factor for establishments in countries where there is a "history of violations". This is nothing more than a risk factor for a region or an entire country. So far, mainly individual criteria have been used here, such as the quality history of the respective site, site type or the time since the last inspection.

The following types of sites are excluded from prioritisation by the SSM described in this MAPP:

• Compounding facilities for the manufacture of human drugs registered under section 503B of the FD&C Act (21 U.S.C. 353b) (drug products compounded by or under the direct supervision of a licensed pharmacist in an outsourcing facility).
• Medical gas sites managed by a separate selection process
• Inactive ingredients (excipients) (may be inspected when deemed necessary)
• Drugs intended for use only in clinical trials (may be inspected when deemed necessary)

Another update concerns a change in the name of a sub-division within the Office of Pharmaceutical Quality (OPQ): "Office of Surveillance" becomes "Office of Quality Surveillance (OQS)".