Remote interactive evaluations: FDA official discusses lessons learned

Regulatory NewsRegulatory News | 29 April 2022 |  By 

To ensure the success of remote interactive evaluations (RIEs), the pharmaceutical industry should treat these evaluations with the same level of attention to detail as onsite inspections,  said Alexander Gontcharov, a staff fellow with the US Food and Drug Administration’s (FDA) Office of Pharmaceutical Quality (OPQ) during the second day of FDA’s Generic Drug Forum on 27 April.
At the meeting, Gontcharov shared some of the lessons learned from the agency’s interactive evaluations of two firms with pending abbreviated new drug applications (ANDAs).
He said that “even though the onsite inspections remain the gold standard, these alternative tools have demonstrated their importance during the COVID public health emergency.”
The elements of RIEs are described in the agency’s guidance issued last April during the public health emergency. (RELATED: FDA issues long-awaited pandemic remote inspections  guidance, Regulatory Focus 14 April 2021)
Gontcharov said since these reviews are not covered under the Food Drug and Cosmetic Act, participation is voluntary. Yet declining a RIE request may delay the agency’s action in approving the application.
Also, because of the voluntary nature of the program, FDA will not be presenting a Form 482 before the inspection, nor will they issue a Form 483 report at its conclusion. If there are deficiencies noted in the inspection, FDA will, however, issue a complete response letter.
Two RIEs, three applications
Gontcharov described the agency’s experience in using RIEs for two sites located outside the US. An RIE was used for one firm with two pending ANDAs for delayed release tablets. The pre-approval inspection (PAI) was triggered because of the firm’s use of a new unit operation using hot melt extrusion.
The second company had a pending ANDA for an aerosol foam drug/device combination product; the PAI was triggered because it is a new type of product.
In both cases, pandemic-prompted travel restrictions prevented onsite inspections, and records reviews were initiated prior to the RIE.
In the first case, the RIE was conducted in four three-hour sessions and the second involved three four-hour sessions. These evaluations were scheduled during business hours.
Both were conducted through zoom video-enabled meetings. In the first evaluation, the firm used a laptop on a cart to share videos of the manufacturing site, as well as external USB cameras and blue-tooth microphones. The second evaluation was conducted through use of computer tablets or a phone connection. There was a walk-through of both facilities’ warehouse, production areas, quality control (QC) labs and stability chambers.
Learnings from RIEs
From these evaluations, Gontcharov imparted some of the lessons learned to ensure these inspections run smoothly and ensure their success. The first is that firms should “commit the same level of importance and attention as you would for an onsite inspection.  Even if you say the RIE is not an onsite inspection, the evaluations could still affect the outcome” of applications, he said.
It is also important for firms to clarify any requests that are not understood before the evaluation, especially those requests involving a high-volume of records.  Gontcharov further advised the importance of having subject matter experts on hand during remote evaluations and to “bring up any translation needs before the RIE starts.”
Manufacturers should also have the requested documents available before the start of the RIE.  “We want to avoid requesting documents twice just because you can’t find them,” Gontcharov said.
He concluded that these evaluations may be here to stay. “FDA is currently analyzing the lessons learned from using them and will communicate its thinking on the topic in the near future.”
FDA Generic Drug Forum


© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you