FDA Defines Criteria for Carrying Out Post-approval Inspections

The FDA is looking to increase its post-marketing inspections of manufacturing facilities, mainly within six months to two years after an approval, focused on ensuring that quality is maintained after a company scales up to commercial production.

The agency’s Office of Pharmaceutical Quality wants to take a more comprehensive approach to assessing quality over the life cycle of a drug product, said Derek Smith, acting branch chief of the office’s Division of Inspectional Assessment, during an FDA conference for industry.

The inspections will cover quality management, laboratory protocols, supplier qualification, and any changes in manufacturing. There is the potential for regulatory action based on the significance of any negative findings.