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June 15, 2020 Life Science Consulting

Pre-Approval Inspection (PAI): What it is and How to Prepare


What is a Pre-Approval Inspection (PAI)?

A PAI is performed to give the Food and Drug Administration (FDA) assurances that a manufacturing site named in a drug application is capable of manufacturing a drug product, and that the submitted data is accurate and complete.

The PAI will assess a drug manufacturing plant’s production capability. The PAI will establish whether the applicants manufacturing plant can adequately produce, and sell commercially, the product it is applying for. Any manufacturing plant named for the first time in the following applications are subject to a PAI:

  • New drug application (NDA) and abbreviated new drug application (ANDA), both human and animal
  • Biologic license application (BLA)
  • Premarket approval application for medical devices (PMA)

A PAI may be conducted at any facility listed in the application, including active pharmaceutical ingredient manufacturers (API), control testing labs, and packaging facilities. During a pre-approval inspection, the FDA inspectors try to ensure the following at each site:

  • cGMP compliance
  • Conformance to application
  • Manufacturing reliability
  • Authenticity and accuracy of data
  • Ability to scale-up
  • Adequacy of analytical methods

How does a company get ready for a PAI?

Companies should consider performing a mock PAI one year before the actual PAI, to allow plenty of time to address any identified issues and prepare for the formal inspection.

To get ready for a PAI:

  • Establish an Inspection Readiness Team
  • Develop list of potential Subject Matter Experts (SMEs) with contact information
  • Set-up two main rooms for audit personnel and activities:
    • Front Room
      • Main audit room
        • FDA and Company representatives
    • Back Room
      • Company War Room for the audit
        • Key personnel
        • Document reviewers
        • SME coaching

The readiness team should meet before the inspection begins to ensure that things are ready for presentation, and to discuss any last-minute issues. During each day of the inspection, after the Inspector leaves, the readiness team should again meet to discuss observations and comments from the day, prepare any needs for the following day, and Answer any questions that may have come up during the inspection.

Companies need to understand that the pre-approval inspection is the starting point for all future inspections. Once approval is granted, your firm is subject to routine inspections. While a risk assessment is used by the FDA to determine the frequency of inspections, domestic firms can typically expect an inspection every 2-years and a firm located outside the United States, can typically expect to be notified of an impending inspection.

Check out our next blog on PAI readiness, where we’ll explain what to do during your mock pre-approval inspection and how to address your findings.


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