FDA official discusses benefits, challenges of remote inspections

The use of remote regulatory assessments (RRAs) has helped the US Food and Drug Administration (FDA) identify “significantly deficient” good manufacturing practice (GMP) violations when officials cannot visit sites. Yet the program does pose some technical and logistical challenges, which can interfere with a manufacturer’s ability to respond to requests for records.

So asserted Ashar Parikh, foreign pre-approval inspection manager for FDA, who spoke on some of the lessons learned on RRAs at the PharmaLink conference hosted by the Regulatory Affairs Professionals Society (RAPS) and the Association of Food and Drug Officials (AFDO).

RRAs may include a request for records or interactive evaluations of an FDA-regulated establishments, can incorporate the use of livestreaming video, and can be voluntary or mandatory. FDA issued a draft guidance on the use of RRAs in July 2022. (RELATED: FDA describes plans to expand remote regulatory assessments, Regulatory Focus, 22 July 2022)

Parikh said that over the past two years, FDA has used records requests for 600 surveillance inspections and 300 preapproval inspections (PAIs), out of which 30% of PAIs are denied. The agency has issued 30 import alerts following RRAs.

The program has “delivered significant benefits,” said Parikh. RRAs have assisted FDA in verifying that corrective actions have been taken in response to previous onsite inspections and have uncovered “significantly deficient” GMP practices. They have also helped reduce delays in marketing approvals.

Based on this experience, FDA has “determined that RRAs are viable and will continue to assist FDA during and beyond the COVID-19 pandemic” to ensure that all products are compliant with the agency’s requirements.

While the program has its benefits, it does pose some problems for manufacturers. “Some of the lessons learned and things to consider is firms misunderstand the request, or the agency is not clear in the records requested,” said Parikh.

“If you have any issues or questions of [document] requested it is ok to ask for clarification,” he said.

There have also been issues related to sending or receiving requested documents, or firms may lack the personnel to gather the requested documents within a specified timeframe. Other problems may be the requested files may be too large to send to the agency, or the firm’s security does not allow the company to upload documents.

Trade groups representing the pharmaceutical and medical device industries, while largely supporting the use of RRA, questioned how these assessments would work in practice and how they would be coordinated with onsite inspections. (RELATED: Remote regulatory assessments: Pharma, device groups want more details on FDA guidance, Regulatory Focus 28 September 2022)

AFDO RAPS meeting

FDA official discusses benefits, challenges of remote inspections

Related topics

Recommended content

Welcome to the new RAPS Digital Experience