FDA official: Virtual audits, records requests may be sticking around

Regulatory NewsRegulatory News | 27 June 2022 |  By 

CHICAGO – The US Food and Drug Administration (FDA) plans to use a hybrid inspection model going forward as it eases out of its pandemic response mode, combining a mix of record requests, remote interactive evaluations (RIEs) with onsite inspections if needed, asserted Alonza Cruse, director of FDA’s pharmaceutical quality operations.
Cruse discussed how the agency is transitioning to normal operators at the 22 June Drug Information Association (DIA) annual meeting in Chicago. Michele Piepoli, a senior quality consultant with MHP Consulting also highlighted some of the challenges with virtual inspections and records requests and shared some best practices on managing these audits.
Cruse added that as the agency resumes its normal operations and enters a “different phase of the pandemic” the agency will continue to use a hybrid model of inspecting sites.
“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],” if an onsite inspection is needed. “Or we will do a remote interactive evaluation to get an initial assessment to decide if we need to send someone over,” he added. “And if we do the RIE and the records request, that may be enough to satisfy” the need for an onsite inspection.
Cruse said that adapting to the new inspection modes has not been problem-free, citing some of the challenges in using these new tools.
“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.”
There are also technical issues with respect to conducting remote interactions evaluations for certain facilities that are difficult to access by cameras.
Piepoli: ‘If you fail to plan, you’re planning to fail’
Piepoli addressed some of the complexities and offered some solutions for hosting remote inspections.
She said that while hosting and conducting remote and onsite inspections poses challenges, conducting inspections remotely “adds another layer” of complexity. The greatest challenge may be the lack of direct human interaction, she said.
“When I am onsite, I am reading body language,” she said, adding that through onsite inspections “you can get that feel, that feel for the organization, and the feel for the people.” A remote inspection “creates a different environment,” she said.
Piepoli noted that it is difficult, if not impossible, to replicate facility walk-throughs with a virtual inspection.
Another challenge is collecting, uploading, and sending the voluminous number of documents to FDA. “What we realized is that on the remote end, the amount of the documents that must be scanned and uploaded into folders is huge, when you think about the validation, there may be hundreds of pages, and there are attachments.”
Piepoli added that firms should ensure the documents are easily retrievable, adding that, “If you fail to plan, you’re planning to fail.”
She further recommended that firms have one point of contact to coordinate remote inspections as “there are a lot of people interacting, there can be three conversations going on.” Lastly, she added that taking digital “breaks” is important.
DIA annual meeting


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Tags: FDA, Inspections

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