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FDA’s hybrid inspection model will remain a regular means for supplementing onsite inspections and will be further integrated into the agency’s oversight operations.
Oversight of drug manufacturing and quality control will continue to utilize off-site reviews of documents and operations, as FDA moves to make permanent these approaches that proved efficient and effective during the COVID-19 pandemic. FDA says this hybrid inspection model will remain a regular means for supplementing onsite inspections and will be further integrated into the agency’s oversight operations as the agency endeavors to restore its field inspection program. That task faces added difficulties as a large number of vacancies in the agency’s field force has expanded the task of replacing and training more inspectors and compliance officials.
The importance of utilizing remote regulatory assessments (RRAs) was highlighted by Commissioner Robert Califf and Associate Commissioner for Regulatory Affairs Judith McMeekin in a recent advisory outlining an “optimized approach” for overseeing manufacturers and supply chains “dispersed around the world” [see RRAs won’t replace site inspections, but these top officials emphasize that they can serve as a practical way to ensure compliance, to verify information submitted to the agency, and to inform key regulatory decisions.
Earlier during the pandemic, FDA officials reported they were utilizing a “wide range of oversight tools” to extend the agency’s regulatory reach where on-site inspections were not feasible. In an advisory posted on March 18, 2021, McMeekin and then-Acting Commissioner Janet Woodcock highlighted the value of alternative inspectional tools for verifying the quality and compliance of regulated products where on-site examination was not feasible. FDA provided added advice on utilizing this approach in a guidance issued in April 2021 on its use of remote interactive evaluations of drug manufacturing and bioresearch monitoring facilities during the pandemic.
New FDA draft guidance now provides more specifics on how the agency will utilize RRAs and how these audits will coordinate with and supplement site inspections. In a question-and-answer advisory on Conducting Remote Regulatory Assessments published July 22, 2022, the agency says that RRAs will be useful in seeking to confirm information more quickly and efficiently, particularly when FDA is unable to send in staff due to travel restrictions.
The draft guidance clarifies the scope and format of RRAs, the type of situations where they will be requested, and how these approaches will relate to and complement site inspections. The advisory explains how FDA will request an RRA and will carry out the process and notes that there are consequences for a manufacturer that declines to participate in an RRA, even when not mandated.
The guidance also informs stakeholders where compliance with RRA requests is voluntary or is required by statute, a policy that FDA would like to expand. Currently, FDA has stated authority to require compliance with RRA requests by certain food importers and by manufacturers of all human and animal drugs and biological products. Pending legislation, which FDA backs, would extend that policy to all regulated establishments, including food producers, clinical investigators, and manufacturers of medical devices and tobacco products.
Over the past two years, FDA reports that it has utilized RRAs in evaluating more than 1470 domestic and more than 600 foreign operations. These methods have identified unreported adverse events, provided information to support import alerts, evaluated how well companies are correcting issues raised in previous inspections, and assisted in making regulatory decisions on premarket submissions. As with other inspection activities, FDA will continue to utilize a risk-based approach to shape RRA requests, examining the location, inspection history, and complexity of products made at a facility.
Jill Wechsler is Washington editor for Pharmaceutical Technology.