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US FDA Sets Post-Pandemic Expectations For Manufacturer Remote Interactive Evaluations

 
• By Bowman Cox

Draft guidance outlines how the agency will use RIEs as COVID-19 becomes endemic and agency staff are generally able to travel for site inspections – and how manufacturing facilities should prepare for them.

Pharmaceutical manufacturing operations
when the fda will swoop in remotely • Source: Shutterstock

Draft guidance the US Food and Drug Administration issued 25 October outlines how and why pharmaceutical companies should prepare to accept requests to host remote interactive evaluations at their manufacturing facilities.

Such evaluations by the FDA and other regulatory agencies, which can include screensharing and video walk-throughs, became popular during the COVID-19 pandemic when inspectors could not travel to conduct site inspections

Key Takeaways

  • Manufacturing facilities should be prepared to host remote interactive evaluations in case the FDA requests them.

  • However, the agency will only request RIEs in specific circumstances outlined in the draft guidance

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