New normal keeps pharma remote audits

Remote Reality

In March 2020, just when people needed to count on dependability from regulatory agencies, a new wrinkle  was thrown into the Food and Drug Administration (FDA) auditing process. Because of COVID-19 health risks and travel restrictions, on-site audits were virtually eliminated, including drug manufacturing sites and contract laboratories worldwide. The FDA only  allowed inspections that were priority or mission critical, including pre-approval inspections for new therapies and for-cause inspections. 

During the pandemic, the FDA also increased its use of inspections by foreign regulators and records instead of inspection. The agency had not used real-time video assessments.

According to Jonathan Davies, Supplier Quality, BTG Specialty Pharmaceuticals, a longtime FDA auditor,  “We’ve long been used to physically inspecting a site, talking to its employees in person, and reviewing original documentation. While remote audits changed all that, the profession has quickly adapted: One recent study out of Germany, for instance, showed no difference in the efficiency and effectiveness of remote internal audits when compared to traditional ones.”

He added, “Now that the shift has been made, it’s unlikely that companies will pay for auditors like me to travel the world. But just because this is the new normal doesn’t mean that nothing’s changed. There are distinctive strategies necessary for doing remote audits successfully. Here’s what we’ve learned about doing them right in the past year.”

Daniel A. Kracov and Howard Sklamberg of Arnold & Porter Kaye Scholer LLP, a legal firm, revealed that on April 14, 2021, FDA published guidance that established a new policy for the use of "remote interactive evaluations." In “Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency: Guidance for Industry (Guidance),” the FDA explained how sites would be selected for these evaluations, how the evaluations would be conducted and concluded, and how the FDA use the information garnered in the evaluations.

The law firm summarized the guidance, which is co-authored by the Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, Center for Veterinary Medicine, and the Office of Regulatory Affairs. The guidance discusses types of manufacturing and biomedical research inspections for biologics and human and animal drugs: pre-approval; pre-license; post-approval; surveillance; and follow-up and compliance. Although the FDA may use remote evaluations to verify some corrective actions, it will require in-person inspections to evaluate remediation after a warning letter, regulatory meeting, or enforcement action. The guidance, which does not affect food, tobacco, or medical device inspections, only stays in effect during the COVID-19 emergency.

As Davies said, “The shift to remote audits — when documentation must be shared online — has, surprisingly, forced us to trust each other more. With that said, it helps to use methods and technologies that offer security, whether it’s signing non-disclosure and confidentiality agreements or giving password-access to an online document repository for 24 hours. Despite all the new technologies, it’s also crucial to remember that successful audits — remote or not — are built on mutual respect, trust and connection.”