Pre-Approval Inspection (PAI): What It Is And How To Prepare

A pre-approval inspection (PAI) is conducted by the Food and Drug Administration (FDA) to ensure that a manufacturing site named in a drug application can consistently produce a safe drug product and that the data submitted is accurate and complete as per the application.

The PAI evaluates a drug manufacturing facility's production capability and determines if the manufacturer can adequately produce and commercially sell the product being applied for. Manufacturers named for the first time in applications such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), Biologic License Application (BLA), and Premarket Approval Application for medical devices (PMA) are subject to a PAI.

The inspection may also extend to supporting vendors and service providers listed in the application, including active pharmaceutical ingredient (API) manufacturers, control testing labs, and packaging facilities. During a pre-approval inspection, FDA inspectors assess:

• Compliance with Current Good Manufacturing Practices (CGMP)
• Alignment with application specifications
• Manufacturing reliability
• Accuracy and authenticity of data
• Scalability of operations
• Adequacy of analytical methods