In new draft guidance for manufacturing inspections, FDA draws inspiration from pandemic methods
The FDA published new manufacturing guidelines on Wednesday detailing “alternative tools” to assess drug manufacturing facilities in pending applications.
The guidance outlines methods previously used by the agency during the Covid-19 pandemic to examine drug manufacturing facilities, back when FDA inspections weren’t possible due to lockdowns and social distancing.
Methods used during the pandemic included requesting records directly from facilities, performing remote regulatory assessments (RRA) — including digital conferences and screen sharing — and requesting existing inspection reports from trusted foreign regulatory agencies.
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.