A risk score will be generated for each site based on empirical evidence collected by FDA, subject matter experts’ judgment or both.

The Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) published a new Manual of Policies and Procedures (MAPP) for the Site Selection Model (SSM) used to prioritize manufacturing sites for routine current good manufacturing practice inspections. As in the past, FDA will use a risk-based approach to inspections of both domestic and foreign drug establishments in order to promote parity in inspectional coverage (i.e., equal frequency for sites with equivalent risk regardless of geography or product type) and effective and efficient use of FDA’s resources.

The Office of Surveillance within the Office of Pharmaceutical Quality is responsible for producing CDER’s Site Surveillance Inspection List (SSIL), which prioritizes sites for inspection. The list is developed from inputting sites from CDER’s Catalog of Manufacturing Sites into the SSM, which ranks sites so that higher risk sites are assigned to the Office of Regulatory Affairs (ORA) for inspection. The SSIL will only prioritize sites scheduled for routine inspection, not other inspection types such as preapproval, postapproval or for-cause inspections. Further, sites excluded from prioritization under this MAPP include human drug compounding outsourcing sites, medical gas sites, inactive ingredients and drugs intended for use only in clinical trials.

The risk factors that SSM will use for each establishment based on section 510 of the Food Drug and Cosmetic Act include:

• Compliance history;
• Record, history and nature of recalls;
• Inherent risk of the drug manufacture: prepared, propagated, compounded or processed;
• Inspection frequency and history, including whether the establishment has been inspected pursuant to section 704 in the last four years;
• Whether it has been inspected by a foreign government or an agency thereof recognized under section 809; and
• “[a]ny other criteria deemed necessary and appropriate by the Secretary for purposes of allocating inspection resources.”

Under this last clause, FDA has included the following additional risk factors for inclusion in the SSM:

• Site type (manufacturing, packager only, control lab only, etc.);
• Time since last inspection;
• FDA compliance history;
• Foreign regulatory authority inspectional history;
• Patient exposure;
• Hazard signals (Field Alert Reports, Biological Product Deviation Reports, MedWatch reports, recalls, etc.); and
• Inherent product risk, including:
  • Dosage form;
  • Route of administration;
  • Products intended to be sterile;
  • API load/concentration in dosage form or unit dose;
  • Biologic drug substance or product;
  • Therapeutic class;
  • Narrow Therapeutic Index drugs; and
  • Emergency use drugs.

A risk score will be generated for each site based on empirical evidence collected by FDA, subject matter experts’ judgment or both. The SSM governance requires an annual review and approval process where CDER and ORA jointly assess this model to make improvements to risk factors, weights and methodology.

For Further Information

If you have any questions about this Alert, please contact Frederick R. Ball, Carolyn A. Alenci, any of the attorneys in our Life Sciences Group or the attorney in the firm with whom you are regularly in contact.

Disclaimer: This Alert has been prepared and published for informational purposes only and is not offered, nor should be construed, as legal advice. For more information, please see the firm's full disclaimer.