Drug Companies Encouraged by FDA to Participate in FY 2025 Site Visitation Program

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A Federal Register notice dated Aug. 8, 2024 announced FDA’s Fiscal Year 2025 Center for Drug Evaluation and Research (CDER) Office of Pharmaceutical Quality (OPQ) Experiential Learning Site Visit Program (ELSVP) (1,2).

The ELSVP, according to a press release from FDA, allows staff to observe commercial manufacturing and testing operations as well as pilot plants, with the goal of better understanding standard operations of the pharmaceutical industry and how those impact the developmental programs and commercial life cycles of drugs (1). It does not replace or supplement a regulatory inspection.

The Federal Register notice identified the ELSVP as part of CDER’s commitment to ensuring that safe, effective, and high-quality drugs are available to Americans, in this case by arranging site visits (2). Companies encouraged to participate include those that engage in the development and manufacturing of either APIs, both small and large molecule, or drug products (1).

Groups of no more than 15 OPQ staff typically come to a site to observe operations over a one- to two-day period. There are a number of areas of interest for these staff members, according to FDA, though it is not an exhaustive list (2):

Drug products:

• Solutions, suspensions, emulsions, semisolids, and solids
• Modified- and immediate-release formulations
• Drug-device combination products regulated by CDER (e.g., inhalation products, transdermal systems, implants intended for drug delivery, and pre-filled syringes)

APIs manufactured by:

• Chemical synthesis
• Fermentation
• Biotechnology

Design, development, manufacturing, and controls:

• Engineering controls for aseptic processes
• Novel delivery technologies
• Hot-melt extrusion
• Soft-gel encapsulation
• Lyophilization
• Blow-fill-seal packaging
• Isolators
• Spray-drying
• Process analytical technology, measurement systems, and real-time release testing

Advanced manufacturing technologies:

• Continuous manufacturing
• 3-dimensional printing
• Nanotechnology

Terminal sterilization:

• Gamma irradiation
• PET drug manufacturing and controls
• Medical gas manufacturing and controls.

The selection process gives priority to facilities on the basis of FDA staff training and a facility’s current compliance standing with FDA, among other considerations (1).

Companies that may want to schedule a site visit, or which simply desire more information, are invited to submit a proposal as of Oct. 1, 2024 to CDEROPQSiteVisits@fda.hhs.gov. Visits will be made within a year of that date, by the close of the next government fiscal year on Sept. 30, 2025 (2).

FDA said proposals should include the following (2):

• a contact person
• site visit location(s)
• Facility Establishment Identifier and D-U-N-S numbers, as applicable
• maximum number of FDA staff that can be accommodated during a site visit (maximum of 15, on average)
• a proposed agenda outlining the learning objectives and associated activities for the site visit
• maximum number of site visits a site would be willing to host by the close of the government fiscal year
• proposed time frames for each site visit (i.e., month or quarter).

If a site is selected for a visit, FDA will collaborate with the contact person provided on appropriate visiting dates.

References

1. FDA. FDA Invites Drug Companies to Participate in Site Visitation Program. Press Release. Aug. 7, 2024.
2. FDA. Office of Pharmaceutical Quality Experiential Learning Site Visit Program; Program Announcement. Notice, Federal Register, 89 FR 64938, 64938–64939, Aug. 8, 2024.