US FDA Is Developing Guidance For Interactive Video GMP Evaluations During COVID-19
While agency prepares guidance, official advises manufacturers to prepare live streaming video systems if they want to host such inspection alternatives.
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Agency may share outcomes of remote record reviews in lieu of inspections at US and foreign facilities.
Contract development and manufacturing organization relied on combination of immersive mixed-reality devices to host remote inspection.
Experience from previous viral outbreaks has allowed the UK agency to move quickly; long-term focus is on hybrid inspection approach.