News about GMP/cGMP

16.04.2021

FDA:New Guidance on remote interactive inspections

FDA:New Guidance on remote interactive inspections

On 14 April 2021 the US FDA has published a new guidance “Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency”. This in fact was long overdue.  It outlines 

  • how remote interactive evaluations will be requested by the FDA and 

  • how they will be conducted for the duration of the COVID-19 pandemic.


The 13-page document describes various interactive and virtual tools and how they will be used for evaluation purposes. They will be applied for any facility processing, packaging or holding pharmaceutical and biological products.

The agency will use existing risk management methods and related tools to determine when to request a facility’s participation in a remote interactive evaluation. This includes various purposes and programs, including

  • pre-approval and pre-license,
  • post-approval, surveillance, or
  • for-cause and bioresearch monitoring programs.  

Even though these are possible candidates the agency points out that there will be instances where only an on-site inspection  is appropriate.

Following any remote inspection a virtual meeting will be held with the site management. In addition the FDA provides a written list with all findings. However, this is not to be considered a final decision by the FDA nor will a "FDA 483" be issued based on such an assessment. Of course, a response from the manufacturer is expected, whether in virtual discussion or in writing within 15 working days.

Facilities can choose to decline the FDA’s request to perform a remote facility evaluation. This may delay the agency’s ability to evaluate the facility or product and make a regulatory decision. The FDA will not accept requests from applicants or facilities to perform a remote interactive evaluation, as decisions to offer a remote interactive evaluation will rest with FDA, based on risk and compliance history.

The guidance was implemented without prior public participation and with immediate relevance. Still, comments may be submitted at any time and will be considered by the FDA. Please note, that the guidance is valid for the duration of the pandemic, only. 

If you are expecting a FDA-request for remote inspection read this document thoroughly to keep all requirements in view!


Source:

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


 

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