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USFDA: Remote Interactive Evaluations of Drug Manufacturing & Bioresearch Monitoring Facilities

Earlier today (25 October,2023), the USFDA issued a draft guidance, "Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities" which replaces guidance issued during the COVID-19 pandemic, Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities during the Public Health Emergency of COVID-19.

In this guidance, FDA describes how to request and conduct voluntary remote interactive evaluations at manufacturing, processing, packaging, compounding, and holding facilities, as well as drug facilities that are covered by FDA's bioresearch monitoring (BIMO) program.

FDA may use alternative tools, such as Remote Regulatory Assessments (RRAs), in advance or in lieu of an inspection or to support an inspection of a facility and assess compliance with applicable laws and regulations.

If a program office determines it is appropriate to conduct a remote interactive evaluation based on mission needs and any travel limitations, FDA may request a remote interactive evaluation. FDA conducts inspections for a variety of purposes and programs, and we may consider each of these inspection program areas for a remote interactive evaluation.

All drug inspection programs are covered by this policy, including but not limited to:

  • Preapproval inspections and prelicense inspections,

  • Postapproval inspections,

  • Surveillance inspections,

  • Follow-up and compliance inspections, and

  • Bioresearch monitoring inspections.

As part of a remote interactive evaluation, FDA may:

  • Request and review documents, records, and other information (electronic systems).

  • Use livestream and/or prerecorded video to examine facilities, operations, and data and other information.

  • Through the facility’s point of contact, schedule interviews and meetings to address any questions or concerns.

  • Evaluate a facility’s corrective actions.

  • Provide verbal updates to the facility on observations and outstanding issues, whenever feasible.

To know more about the Technological Requirements, Response Timeframes for Remote Interactive Evaluations, etc. click this LINK.


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