How The European Medicines Agency Inspected Thermo Fisher’s Florida Plant Without Leaving Europe
Contract development and manufacturing organization relied on combination of immersive mixed-reality devices to host remote inspection.
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Stance echoes US FDA’s view that remote alternatives should be “supplemental tools” to support in-person inspections.
US, EU, global authorities share experiences, insights, advice for industry on remote alternatives even after inspectors can resume travels.
Compared to FY2019, FDA data show agency inspections of OTC and Rx drug manufacturing facilities in FY2020 fell 60%. As pandemic continues in FY2021, inspection rate will remain depressed, and it remains unclear how the agency will reduce the backlog without resorting to remotely conducted inspections.