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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Stance echoes US FDA’s view that remote alternatives should be “supplemental tools” to support in-person inspections.
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.
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.