FDA Weighs in on Remote Inspections

On April 14, 2021, FDA issued guidance on conducting remote inspections, or, as the agency is calling them, “voluntary remote interactive evaluations (VRIEs)” at pharmaceutical and biologics facilities, using videoconferencing software, 360-degree video inspection, and other tools. The agency had been criticized for failing to take a stand on the use of remote inspection technologies in light of a growing backlog of plant inspections and delays in new drug approvals due to concerns about putting inspection staffers at risk of contracting COVID-19.

The guidance’s wording makes it clear that the agency views use of these technologies as a temporary measure, only for as long as US health authorities continue to define the COVID-19 pandemic as a public health emergency. However, it also suggests that FDA may use remote technologies in the post-COVID-19 world, as a way to supplement inspections, gain additional insights into issues found during a traditional inspection, or clarify questions or support a new drug application. The guidance also hints that technology may be used as a preliminary step, to better define the scope, depth, and timing required for future in-person inspections.

The guidance was issued without the customary public comment period, although FDA’s conservative approach and silence on the subject of remote technology had been discussed widely in the press and at industry events. Remote interactive evaluations would be used for pre- and post-approval inspections, surveillance inspections, follow-up and compliance visits, and bioresearch monitoring inspections.

FDA will use risk-management tools to determine when to ask a facility to participate, and may requests records or ask the company to take part in a VRIE before an on-site inspection.The agency also emphasized that it will not accept requests from facilities to perform inspections remotely, but will notify the facility if it wishes to set up a VRIE. FDA will contact the company and ask for information required to plan the evaluation ahead of time.

Preparing for the evaluation

In order to prepare for the evaluation, FDA will schedule a brief meeting with the company to discuss staffing, key contacts and roles, logistics, expectations, and to outline key responsibilities. It will also ascertain any time zone differences and needs for interpreters.

Among the issues to be examined would be the facility’s capacity to host such evaluations, specifically the host facility’s internet access and its ability to live stream video and audio during an actual inspection. Discussions will come to an end if it is found that there is insufficient bandwidth or that remote video will not give adequate visibility into the operations or segments of the facility being evaluated.

FDA also says that it will not issue a Form 482 for these evaluations and that it will use its own government-issued Microsoft Teams, Zoom, and Adobe Connect platforms. It also asks that facilities be sure to make electronic documents accessible for sharing.

FDA also asks that facilities that are still using paper documentation ensure that it is scanned into PDFs when possible.

Source: FDA