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Pharmaceuticals / Quality

FDA Issues New Manual for Prioritizing Site Inspections

Sept. 7, 2018

The FDA released a new manual of policies and procedures (MAPP) outlining how it prioritizes manufacturing facilities for routine CGMP surveillance inspections.

The agency considers drug quality-related risks that can result from CGMP violations, taking into account specific risk factors, such as the site’s compliance history, recalls, and the inherent risk of drug products made at the facility and the facility’s inspection frequency and history.

One goal of the site selection model is to “achieve parity” in inspection frequency for sites with equivalent risk, “regardless of geography (foreign versus domestic), or product type,” the MAPP says.

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