FDA Guidance: Alternative Tools for Site Assessments

The FDA has issued guidance on how alternative tools can be used alongside or instead of traditional on-site inspections to assess manufacturing facilities named in pending applications. 

The goal is a risk-based, flexible, and timely evaluation of production sites. FDA decides case by case whether alternative tools are sufficient or an on-site inspection is required. The guidance does not apply to other drug inspection programs (e.g. postapproval inspections or surveillance inspections).

Which tools are available?

• Remote Regulatory Assessments (RRA):
  • Records requests under §704(a)(4) FD&C Act (e.g., validation reports, deviations, test results, complaints).
  • Remote Interactive Evaluations (RIE): Livestream video, screen sharing, teleconferences.
• Collaboration with foreign regulators:
  • Use of inspection reports from trusted partners (EU, UK, Switzerland, MRA partners).
  • Joint inspections: local lead inspector with FDA participating remotely.
• Remote Subject Matter Experts (SMEs):
  • FDA experts virtually support on-site inspection teams when specialized knowledge is needed.

Applied especially when:

• Facilities have a strong inspection track record (FDA or MRA partner),
• Products are urgently needed (e.g., shortages, public health needs),
• On-site inspections are not feasible (travel restrictions, pandemics, natural disasters).

Advantages of alternative tools:

• Speed: Supports timely decision-making and meeting PDUFA/BsUFA deadlines.
• Flexibility: FDA can maintain oversight even when travel is restricted.
• Risk focus: Resources concentrated on high-risk facilities or processes.
• Global harmonization: Reliance on partner inspections reduces duplication and accelerates approvals across markets.
• Efficiency: Remote SMEs provide expertise without requiring travel.

Source:

FDA: FDA Guidance Documents - Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications