UK MHRA Relies On Remote Drug GMP Inspections As COVID-19 Pandemic Grounds Inspectors
Experience from previous viral outbreaks has allowed the UK agency to move quickly; long-term focus is on hybrid inspection approach.
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ICMRA Review Finds Remote Alternatives Could Complement Onsite Inspections, Not Replace Them
Stance echoes US FDA’s view that remote alternatives should be “supplemental tools” to support in-person inspections.
Remote Site Visits Will Help US FDA Keep Reviews On Track As Pandemic Constraints Continue
Guidance discusses what are generically called virtual inspections, but which the agency terms “remote interactive evaluations.” As site inspections remain constrained by the pandemic, remote interactive evaluations “should help FDA operate within normal timeframes,” the document says.
FDA Guides On Virtual Inspections During COVID-19
Details of how the FDA plans to conduct remote evaluations of manufacturing facilities during the COVID-19 pandemic have been set out in guidance published by the US agency.