News about GMP/cGMP


FDA: Update on remote inspections guidance and future roadmap

FDA: Update on remote inspections guidance and future roadmap

On 17 May 2021 the USFDA has released a revised version of its Q&A guidance on remote inspections. The 14-page document was originally published in August 2020 (we reported). As the pandemic still restricts most onsite inspections the FDA further clarifies general questions that came up since then.

What’s new?

  • It is clarified under which circumstances a pending application may be approved when a physical inspection cannot be conducted
  • Detailed information is given regarding the issue of "complete response (CR) letters" in case of remote inspections. Two scenarios are outlined, one with GMP deficiencies being recognised or without.
  • The action FDA will take if a decision on an application has to be deferred due to insufficient information for conducting a remote inspection is described.

The roadmap
With an overall inspection backlog the FDA is taking additional steps to bridge the gap. A “resiliency roadmap” addresses the various challenges. It details how the pandemic has delayed all but the most important and high priority inspections last year with a huge amount of inspections still open. Furthermore current and future activities are layed out. With this roadmap a more consistent state of operations shall be achieved.


FDA: Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency