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Drug Regulators Turn to Zoom-Style Plant Inspections During the Pandemic

For the past year the pandemic has brought a halt to in-person inspections of many pharmaceutical manufacturing facilities around the world. With a backlog of more than 1,000 audits to clear, the U.S. Food and Drug Administration is facing pressure to embrace something it’s long eschewed: virtual inspections of foreign drug plants.

Inspectors from some Western nations, including the U.K. and Japan, plus the Council of Europe have tried alternatives to in-person audits, such as assessments that use head-mounted cameras, mobile Wi-Fi hotspots, web conferencing, and confidential document-sharing tools. Although they’ve been pleased to continue the global flow of medicine production during the pandemic, some inspectors admit that on-site audits allow better scrutiny, including the ability to conduct surprise inspections, ask questions in real time, and fully review sterile conditions inside facilities.

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This article originally appears at Bloomberg Businessweek. To read the full article, click here.


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