By Mark Durivage, Quality Systems Compliance LLC
On April 14, 2021, the FDA released a new guidance, Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency, to address the coronavirus disease 2019 (COVID-19) public health emergency. This guidance was implemented without prior public comment because the FDA determined that prior public participation was not feasible or appropriate. However, public comments may be submitted at any time for agency consideration.*
During the COVID-19 public health emergency, the FDA is limiting unnecessary contact by only conducting prioritized domestic facility inspections and those that are deemed mission-critical. For unprioritized inspections, non-mission-critical domestic inspections, and inspections impacted by travel restrictions resulting from the public health emergency, the agency is using voluntary remote interactive tools to support regulatory decisions and oversight of facilities.
Planning A Remote Interactive Evaluation
The FDA may request to conduct a remote interactive evaluation for pre-approval inspections (PAIs), pre-license inspections (PLIs), post-approval inspections (PoAIs), surveillance inspections, follow-up inspections, compliance inspections, and bioresearch monitoring (BIMO) inspections using a risk-based approach. The FDA may request records or request that a facility participate in a remote interactive evaluation prior to an on-site inspection. Facilities or applicants are unable to request the FDA to perform a remote interactive evaluation.
Facilities eligible for a remote interactive evaluation will be notified by electronic correspondence or phone call. The correspondence will confirm the facility’s willingness and ability to participate in a remote interactive evaluation, including the use of teleconference, livestream video, and screen sharing of data and documents. Once a remote interactive evaluation is confirmed, the FDA will schedule a brief virtual meeting to discuss the logistics, responsibilities, and expectations. The FDA will not issue a Form FDA 482, Notice of Inspection, to announce or open a remote interactive evaluation.
Conducting A Remote Interactive Evaluation
The FDA has an expectation that the connectivity and image quality will be adequate to remotely review, observe, examine, and evaluate the information requested, with minimal issues. The FDA will initiate remote interactive evaluations using FDA Microsoft Teams, FDA Zoom for Government, or FDA Adobe Connect to ensure security of the platform. The agency will provide a secure means to send requested information (documents and videos) during a remote interactive evaluation. All documents submitted to the FDA must be in English with paper documents scanned and provided as searchable bookmarked Portable Document Format (PDF) files when possible, to facilitate review.
Concluding A Remote Interactive Evaluation
The FDA will have a closeout meeting with the facility’s management upon completion of a remote interactive evaluation. If necessary, the FDA will present a written list of observations describing and discussing any observations. This will replace the traditional issuance of Inspectional Observations Form FDA 483. These written observations are not a final agency action or decision. The FDA will encourage the facility to submit a formal response to the observations in writing within 15 business days.
The FDA will provide a copy of the final remote interactive evaluation report to the facility. The report and any written list of observations may be subject to a disclosure request under the Freedom of Information Act. The results of a remote interactive evaluation may be used by the FDA to determine if an on-site inspection is required. The information obtained from the remote interactive evaluation can be used by the FDA to prepare for and conduct the on-site inspection.
Impacts Of Remote Interactive Evaluations On Established Commitments And Timeframes
The FDA intends to operate within normal timeframes using remote interactive evaluations, which should allow for prioritization of other activities. The agency intends to use information from remote interactive evaluations to meet user fee commitments (ensure timely reviews of applications for drugs and biological products) and intends to adhere to existing response timeframes applicable to pre-approval and pre-license inspections. The FDA will consider responses or corrective actions to observations if provided within 15 business days. Responses or corrective actions to observations received after 15 business days may be deferred for consideration and will be considered in the next application cycle.
For other inspections, the FDA generally intends to use existing timelines established for reporting on and evaluating the outcome of an inspection for remote interactive evaluations. The FDA will consider responses or corrective actions to observations if provided within 15 business days with respect to further regulatory action.
Recent changes in the organization, structure, and philosophy at the FDA are a positive sign for the pharmaceutical industry. By rapidly adapting to situations such as the COVID-19 public health emergency, the FDA continues to promote safety, efficacy, and security of drugs through fostering pharmaceutical development and manufacturing innovation and streamlining the compilation and assessment of marketing applications. It is important for organizations to treat remote interactive evaluations with the same degree of seriousness as any on-site inspection. Additionally, organizations must ensure that appropriate responses are submitted in 15 business days.
As an industry, I hope we can prove that using remote interactive evaluations is an effective means to interact with the FDA, enabling the FDA to build confidence in the process and consider using remote interactive evaluations when the COVID-19 public health emergency passes.
* Submit written comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852 or electronic comments to https://www.regulations.gov. Please reference docket number FDA-2020-D-1136 and the complete title of the guidance with all comments.
About the Author
Mark Allen Durivage has worked as a practitioner, educator, consultant, and author. He is Managing Principal Consultant at Quality Systems Compliance LLC, an ASQ Fellow and SRE Fellow. Durivage primarily works with companies in the FDA regulated industries (medical devices, human tissue, animal tissue, and pharmaceuticals) focusing on quality management system implementation, integration, updates, and training. Additionally, he assists companies by providing internal and external audit support as well as FDA 483 and warning letter response and remediation services. He earned a BAS in computer aided machining from Siena Heights University and an MS in quality management from Eastern Michigan University. He holds several certifications, including CRE, CQE, CQA, CSSBB, RAC (Global), and CTBS. He has written several books available through ASQ Quality Press, published articles in Quality Progress, and is a frequent contributor to Life Science Connect. You can reach him at email@example.com with any questions or comments.