FDA publishes Guidance for Remote Interactive Evaluations - but not to replace Inspections

Recommendation

13/14 December 2023
Berlin, Germany

Root Cause Analysis
A CAPA Workshop on Successful Failure Investigation

Since the beginning of the pandemic and the associated travel restrictions, inspectorates as well as pharmaceutical companies have started to carry out distant assessments/ remote audits. However, such assessments or even virtual inspections of drug manufacturers have not yet been carried out by the US FDA. This procedure has been criticised by many, as it leads to delays in the completion of inspections, the approval of drug applications or even in the removal from the so-called Import Alert List. The backlog of inspections to be carried out is now large.

Now, finally, the FDA has published a Guidance for Industry that addresses the issue. Those who hoped that this would mean that the FDA would carry out distant assessments with the same or comparable significance of an on-site inspection are disappointed. Even the title "Remote Interactive Evaluations" avoids the word inspection or assessment. A footnote explains that these remote evaluations do not meet the legal definition of an inspection. Ultimately, such a remote evaluation can only serve as a supplement to an inspection. Towards the end of the document, the possible use or benefit is described:

• "Support FDA's assessment of pending applications, including whether to approve an Application
• Preclude the need for an inspection in follow-up to a reported concern or defect
• Support a regulatory meeting, warning letter, import alert, recall activities, or  enforcement action
• Rank or prioritize a facility for an inspection, particularly a surveillance CGMP Inspection
• Justify a follow-up or compliance inspection or any other surveillance activity"

A company itself cannot request a remote interactive evaluation ("We will not accept requests from applicants or facilities for FDA to perform a remote interactive evaluation" the FDA states in the Guidance).

The procedure described is very similar to a virtual inspection. Interesting aspects here are, for example:

• After the decision to perform a remote interactive evaluation, the company is notified. The company must confirm that it is willing and able to support the technical aspects of the evaluation.
• The FDA says that it will "use its own IT platforms and equipment to host virtual interactions during remote interactive evaluations (e.g., videoconferences, livestreaming video of the facility and operations in the facility)."  In doing so, FDA expects the company to cooperate in the use of "livestream and/or pre-recorded video to examine facilities, operations, and data and other information." 
• Like other agencies, FDA will hold brief virtual meetings prior to the actual remote interactive evaluation to discuss processes and respective responsibilities during the remote evaluation.
• During the remote evaluation, FDA may request and review documents, records, and other information (made available in an electronic format or through screen sharing).
• Interviews and meetings may be conducted.
• "Livestreaming walkthroughs of the facility" may be conducted, including evaluation of work processes.

After the remote interactive evaluation, FDA will prepare a report and provide a copy to the facility, but not a Form 483 as is the case with inspections. However, there will not be a big difference, the contents are comparable and the company has 15 working days to respond in writing.