• Global Audits

FDA Pre-Approval Inspections

Executive Summary

The FDA’s Pre-Approval Inspection (PAI) is a critical time-to-market pre-requisite to getting your new drug product licensed and approved for commercial manufacturing. Unanticipated delays, caused by unfavorable PAI results can cost millions of dollars.

This white paper provides discussion on:

  • The criteria used by FDA for deciding whether an inspection is to be conducted for a given application
  • The two types of pre-approval inspections performed – Priority and Discretionary
  • The composition of the FDA inspection team
  • Pre-PAI readiness assessment focus areas to improve your probability of success
  • A summary of types of findings or deficiencies that will result in a recommendation to withhold PAI approval
  • Special considerations for virtual companies

Through covering the above topics, this material will present critical information regarding Pre-Approval Inspection Audits and also demonstrate how a Pre-PAI Readiness assessment can maximize


The Federal Food, Drug, and Cosmetic Act provides that FDA may approve a New Drug
Application (NDA), an Abbreviated New Drug Application (ANDA) or a Biologic Licensing Application (BLA) if, among other requirements, the methods used in, and the facilities and controls used for, the manufacturing, processing, packaging, and testing of the drug are found adequate, and ensure and preserve its identity, strength, quality and purity.

Another important regulatory initiative is FDA’s “Pharmaceutical Current good Manufacturing Practices for the 21st Century.” Published in 2002, this initiative encourages implementation of risk-based and science-based approaches that focus agency attention on critical areas and incorporate inspection of the level of the applicant’s process and product understanding, an evaluation of the firm’s manufacturing readiness and verification of authenticity of submitted data.

These 2 regulations then, direct the FDA district office in the evaluation of establishments by on-site inspections and/or the establishment file review when a firm is named in the Chemistry, Manufacturing and Controls (CMC) section of a New Drug Application, Abbreviated New Drug Application, or Biologic Licensing Application.

In discharging its responsibilities, the FDA’s compliance program establish criteria for deciding whether on-site pre-approval inspections (PAIs) are to be conducted for a given application. In some cases, FDA may have sufficient current and pertinent information to arrive at scientific decision on site acceptability without conducting a PAI. The programs risk-based criteria for performing an on-site inspection for an application is meant to ensure that the agency’s inspection resources are directed to the greatest possible protection of public health.



  • Clintrak - Jeffrey D. Coffin
    I have had the great pleasure to work with Bob for 5 years in his position of VP of Quality at Fisher Packaging Services while I acted as Director of Quality services at a sister…
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