The FDA may be easing from its pandemic response mode, but, like any industry and nearly every organization, two years of pandemic have normalized remote work for the agency and forced improvement in remote inspections. The FDA announced during the annual Drug Information Association (DIA) meeting on June 22nd that they do not plan to return to pre-pandemic practices, but will instead be adopting a hybrid inspection model moving forward, combining a mix of record requests, remote interactive evaluations (RIEs) with onsite inspections, if deemed necessary.
“These will be tools, in my opinion, that we’ll continue to adapt to use. We will adapt the hybrid model or other models that will still help us. We’ll do a records request, and we’ll have an inspector in the facility for a focused [inspection]…or we will do a remote interactive evaluation to get an initial assessment to decide if we need to send someone over.” – Alonza Cruse, director of FDA pharmaceutical quality operations
As we reported earlier in the year, there are many challenges with remote audits and inspections, but most are confident that the practices are here to stay and that the challenges will cause rapid improvement in technologies and methods to make these interactions even more effective than their traditional, onsite only counterparts. Cruse echos this when discussing technical issues with cameras during certain facility inspections and also the potential to collect more and better data stating,
“There are challenges of scale up. Now that we’re able to collect this data, what do we need to do now to turn that data into meaningful information that the agency can use in its decision-making process, either for a pre-approval inspection or a surveillance inspection perspective, or a follow-up to a violative inspection to determine corrective actions.”
Senior quality consultant with MHP Michele Piepoli expressed some of the same challenges but also remained optimistic and provided some advice for folks conducting and taking part in remote inspections.
Noting some of the nuance that is lost when interacting virtually vs. actually sitting in a room with a person or group of people where body language can be read and more casual conversation can be had, Pipoli said, “When I am onsite, I am reading body language…you can get that feel, that feel for the organization, and the feel for the people,” but the remote inspection “creates a different environment,” she said.
Piepoli remained optimistic and did say that, while difficult, it’s not impossible to replicate an actual onsite facility walkthrough with current technology, but seemed to lament the additional challenges associated with the amount of records and documents that need to be scanned and uploaded into folders to be shared with inspectors. She provided some advice for those being inspected in a remote setting: be prepared. She noted that if organizations didn’t plan beforehand to have necessary records and documents scanned and uploaded, they were asking for issues during the inspection.
Piepoli seems more ready to accommodate current realities in an attempt to replicate the traditional methods and, hopefully, their results, and she sees additional preparation as a way for folks to better accommodate the new challenges, but we see the new challenges as something to be embraced to improve auditing methods and technologies. These new challenges aren’t just something for us to sidestep around to try to emulate the way things used to be, they’re there for us to overcome and change the methods and results forever for the better.