FDA CDER updates internal policy for Risk-Based Manufacturing Site Selection

 For those in the CMC space, the latest from the FDA's CDER on how they do risk-based manufacturing site selection:

FDA recently published a revision to Manual of Policies and Procedures (MAPP) 5014.1, Understanding CDER’s Risk-Based Site Selection Model (https://www.fda.gov/media/116004/download?utm_medium=email&utm_source=govdelivery). This MAPP outlines how the Office of Pharmaceutical Quality (OPQ) will manage the Site Selection Model (SSM) to prioritize manufacturing sites for routine quality-related (i.e., current good manufacturing practice) surveillance inspections. The MAPP revisions include:

--Updating the model by adding a risk factor about the compliance history of establishments in the country or region in which an establishment is located.

--Providing clarity on the risk factors associated with patient exposure and inherent product risk.

--Adding language about quality system effectiveness.