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USFDA released an internal procedure on prioritization of inspection of manufacturing facilities

An internal Manual of Policies and Procedures called MAPP had been released by USFDA which reveals how pharmaceutical manufacturing sites are prioritized and selected for surveillance inspections.

According to MAPP which is a 7 page document, the Office of Surveillance, within the Office of Pharmaceutical Quality, is responsible for producing CDER’s Site Surveillance Inspection List (SSIL) that prioritizes sites for surveillance inspections. The decision to release MAPP was taken when FDA’s inspections program in Fiscal year 2017 had to decide what sites to be inspected from across 5063 human pharmaceutical sites worldwide. Out of these 3025 sites are outside the U.S. Total inspections carried out by USFDA in 2017 were 1453 out of which 762 were outside US and was conducted to ensure that the manufacturing facilities are adhering to cGMP norms.

FDA prioritizes the inspections regardless of location. CDER utilizes The Site Selection Model (SSM) to prioritize manufacturing sites for routine quality inspections. The criteria which CDER selects are risk related to drug (drug substance and finished product) quality as may arise from violations of cGMP requirements as mentioned in section 510 of the Food Drug & Cosmetic Act (FD&C Act).This section identifies specific risk factors and allows FDA to determine additional ones, including

the compliance history of the establishment

the record, history and nature of recalls linked to the establishment

the inherent risk of the drug manufactured, prepared, propagated, compounded or processed at the establishment.