Site Compliance History Key to FDA Surveillance Inspection Priorities

The FDA has updated how the Office of Pharmaceutical Quality (OPQ) will select manufacturing sites for routine surveillance inspection, using information about the compliance history of sites “to promote parity in inspectional coverage and the effective and efficient use of FDA resources to address the most significant public health risks.”

The revision of the Manual of Policies and Procedures (MAPP) 5014.1, “Understanding CDER’s Risk-Based Site Selection Model,” is intended to provide clarity on how the agency prioritizes manufacturing sites “for routine quality-related (i.e., current good manufacturing practice) surveillance inspections.”

The update includes additional information on “the risk factors associated with patient exposure and inherent product risk” as well as “adding language about quality system effectiveness.” Also updated is the name of the OPQ suboffice, Office of Surveillance, to its new name, Office of Quality Surveillance.

The policy only applies to prioritizing sites that are subject to routine surveillance inspections, such as those that commercially manufacture a finished drug product, an in-process material, or an active pharmaceutical ingredient (API) for use in a drug intended for humans.

Read the updated manual here.

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