In September of 2018, FDA's CDER published and implemented a new Manual of Policies and Procedures (MAPP) describing the Site Selection Model (SSM) used to prioritize manufacturing sites for routine CGMP surveillance inspections under the Agency's 'risk-based' approach.

As stated, FDA aims to use this model to make the most effective and efficient use of limited resources in an increasingly global manufacturing industry.

According to the Inspection MAPP, while FDA has officially used a 'risk-based" approach for prioritizing pharmaceutical drug manufacturing inspections since FY2005 (which was codified in 2012 with Section 510(h) of the FFDCA, replacing the prior statutory two-year inspection cycle), data from FDA's Inspection Data Dashboard reveals that many establishments are still inspected every two to three years.

This guide offers a clear and simple summary of the background surrounding these policies, what the stated risk factors are, and what FDA-regulated manufacturers can do to prepare based on the information available.

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