The FDA has just revised its MaPP 5014.1 titled Understanding CDER’s Risk‑Based Site Selection Model. Remember, MaPP stands for Manual of Policy and Procedures, and MaPPs instruct internal FDA staff on proper procedures. The FDA publishes these MaPPs to provide greater transparency to stakeholders so they can better understand how the Agency does something or how it may reach a decision on a particular issue. The FDA says that this MaPP describes how it uses the Site Selection Model (SSM) to prioritize manufacturing sites for routine quality‑related (i.e., current good manufacturing practice) surveillance inspections.
The Agency notes the following revisions in the MaPP:
- Updating the model by adding a risk factor regarding the compliance history of establishments in the country or region in which an establishment is located. This update was made in accordance with an amendment to section 510(h)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) by the Food and Drug Omnibus Reform Act of 2022 (FDORA 2022)
- Providing clarity on the risk factors associated with patient exposure and inherent product risk.
- Adding language about quality system effectiveness.
- Changing the name of the Office of Pharmaceutical Quality (OPQ) suboffice known as Office of Surveillance to Office of Quality Surveillance (OQS).
This document, which can be found here, describes the risk‑based approach that the FDA will take and defines the criteria that will be taken into account in making routine surveillance inspection decisions.
