Draft guidance from the US Food and Drug Administration (FDA) outlines the Agency’s approach for remote interactive evaluations (RIE) of pharmaceutical and biologics facilities in lieu of onsite inspections and how industry can prepare for these inspections. The draft guideline was issued on 25 October 2023. The Agency wants to continue using this auditing mode following its “successful use” during the COVID-19 pandemic. The guidance was jointly issued by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). The guidance covers preapproval inspections, pre-license inspections, post-approval inspections, surveillance inspections, follow-up and compliance inspections, and bioresearch monitoring (BIMO) inspections. It replaces an earlier version issued in April 2021.
FDA “often utilized voluntary remote interactive evaluations during the COVID-19 pandemic. After their successful use, FDA is issuing the draft guidance to inform industry about the Agency’s continued use of such remote evaluations as an approach for evaluating drug facilities, as appropriate,” according to an agency statement. The Agency plans to use risk management methods to determine when it will request an RIE and will not accept requests from applicants to perform one.
FDA will then schedule a virtual meeting with sponsors to discuss logistics and responsibilities. The meeting will cover the objectives and scope of the RIE, introduce the FDA remote interactive evaluation team and identify the facility point of contact. The draft guidance states that “when facilities agree to participate in a remote interactive evaluation, FDA expects them to cooperate with the same level of transparency as they would during an FDA inspection. We expect appropriate staff to be available at scheduled times for interviews and other virtual interactions, and we expect the facility to be operational to the extent possible for FDA to evaluate areas and operations of interest (e.g., manufacturing, laboratory, packaging).” As part of a remote interactive evaluation, FDA says it may:
- Request documents, records, and electronic systems;
- Use livestream or video to audit facilities and operations;
- Schedule interviews and meetings to address any questions or concerns; and
- Evaluate any corrective actions in response to a previous inspection or current RIE.
The guidance states that “an inspection instead of a remote interactive evaluation may be necessary to verify the adequacy of some corrective actions, or if evaluating the corrective actions remotely would unreasonably extend the duration of the remote interactive evaluation. These RIEs will be used as the basis to support FDAs decision on whether to approve an application, issue a Warning Letter (WL) or import alert, prioritize the facility for a surveillance GMP inspection, or justify the need for a follow-up compliance inspection.
To participate, a firm’s technology capabilities should be up to par, according the draft guidance. “The quality of the remote connection (e.g., connectivity, image quality, cameras used) should be adequate for FDA to remotely review, observe, examine, and evaluate the information requested. To the extent practicable, technologies employed also should allow access for clear and stable remote viewing and evaluation of operations at the facility, as necessary (e.g., aseptic practices, equipment cleaning and set up, material weighing and dispensing, instrument set up, sampling, testing).”
Firms should also be able to provide all documents in an electronic format or made accessible by screen sharing. FDA says for security reasons, it will use its own IT platforms and equipment to evaluate facilities through FDA Microsoft Teams, Zoom for Government and Adobe Connect. Upon completion of the inspection, FDA will have a closeout meeting with management. If problems are found, the agency will issue a written list of observations. This written list, said FDA, “will not be a final Agency action or decision.” This list is also not considered a Form FDA 483, or inspectional observation report. Firms will be given 15 US business days to respond. The deadline to submit comments is 26 December. Comments should be addressed to docket number: FDA-2023-D-4416
REFERENCE: Regulatory Focus (A RAPS Publication); 29 OCT 2023; Joanne S. Eglovitch