FDA resuming normalized operations but will continue to leverage MRAs
As the US Food and Drug Administration (FDA) returns to normalized operations with onsite inspections, it will continue to take a risk-based approach in determining which firms are inspected next and continue to rely on mutual recognition agreements (MRAs) with other countries in assessing pharmaceutical facilities, according to Alonza Cruse, director of FDA’s pharmaceutical quality operations.Cruse discussed how the agency is transitioning to normal operations on 14 March at the ISPE Aseptic Conference, held virtually and in Bethesda, MD, by the International Society for Pharmaceutical Engineering (ISPE).
FDA resumed routine domestic surveillance inspections and mission-critical foreign inspections in early February. (RELATED: FDA to resume routine domestic surveillance inspections next week, Regulatory Focus 4 February 2022)
Cruse said FDA is "getting our staff up and out there" in conducting domestic and foreign inspections. The agency also will continue to take a risk-based approach in deciding which firms to inpsect next in prioritizing its workload. For example, firms that make sterile injectables or those with a narrow therapeutic range are deemed higher-riskdrugs and will be accorded higher inspectional priority that low-risk drugs.
He further noted that during the pandemic the agency increased its use of MRAs with trusted authorities, and this practice will continue. The use of MRAs “has really assisted [other regulators] as they have assisted us,” said Cruse, adding that “these relationships will grow as we gear back into normalized operations.”
Cruse said that even as the agency prepares for onsite inspections, the use of alternative tools, including remote interactive evaluations (RIEs) will not go away anytime soon. The agency issued a guidance in outlining the use of RIEs in April 2021. (RELATED: FDA issues long-awaited pandemic remote inspections guidance, Regulatory Focus 14 April 2021)
Cruse said for RIEs, “we are asking firms to interact with us or use something other than producing a document.”
To ensure a smooth RIE with regulators, Cruse said firms should ensure they have a “good internet connection, and not just in the conference room, as the remote interactive activities may take us through different part of the facility.”
He also recommended that firms have “good portable equipment, whether it is a tablet or a phone” as it is “more difficult to transport a whole computer or a landline phone throughout the interactive evaluations.”
Firms should also ensure that documents can be electronically shared; he also stressed the importance of having translators available onsite during the evaluation, where appropriate.
ISPE meeting
