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FDA Postpones Foreign Inspections

June 1, 2020  •  Blog  •  Reginald Neal, B.Sc. Senior Consultant, CGMP Quality Compliance
Posted In Compliance News & Insights – Biologics Consulting  •  Tagged compliance, foreign inspections, GMP, inspections, QMS, quality

As FDA is postponing most foreign inspections through April in response to the COVID-19 outbreak, there will undoubtedly be an impact on product application reviews and biennial GMP inspection approvals. During this time, FDA has committed to take interim measures that may include inspection waivers subject to review of a firm’s compliance history, the use of information sharing from foreign governments as part of mutual recognition and confidentiality agreements, and requesting records “in advance of or in lieu of” on-site drug inspections. In those instances where the above referenced measures will not be an option [e.g., licensing applications not subject to approval based on information sharing from foreign governments], industry should take this opportunity to review and streamline the Quality Management System to facilitate the best presentation of information and metrics once compliance inspections are scheduled and resume. This is the perfect time to perform a review of Quality Management procedures and Quality Metrics. Now is the time to think strategically to mitigate the risk of inspectional observation citations and avoid application approval delays due to time constraints to implement CAPAs.