• Global Audits

Pre-Approval Inspection (PAI) Training Services

How many people in your organization have a firm understanding of the FDA’s Pre-Approval Inspection (PAI) process? More importantly, how many have actually been through a PAI recently and know what to expect and how to prepare?

The possibility of an unfavorable result in your PAI can cause un-anticipated delays in licensing and commercial manufacturing of your product and can cost millions of dollars.

USDM’s industry experts can enhance your readiness and probability of successfully passing the FDA PAI by providing training to your staff members for

  • Your risk of being classified as a priority or discretionary PAI candidate
  • Your organization’s Profile class assessment
  • Unique design or medical device delivery features that will likely trigger a PAI
  • Risk assessment and prioritization of your contract manufacturing organizations (CMOs)
  • How to effectively discharge your responsibilities for QA oversight of API and CMO suppliers
  • Where your CMO organizations responsibilities end and your responsibilities as drug sponsor begin
  • Examples of types of observations that are likely to result in withholding of PAI approval
  • The influence of generic drug manufacturing on FDA’s PAI strategy
  • CGMP, ICH Q7A and Pre-PAI audits, readiness assessments and remediation
  • The importance of evaluation of your suppliers Quality Systems and state-of-control
  • Establishing or evaluating your QA oversight program of critical CMOs
  • Establishment and enforcement of Quality Agreements with API and CMO suppliers
  • Evaluation of your organization’s readiness for manufacturing including ensuring that you have a Quality System in place that is designed to achieve sufficient control over the facility and commercial manufacturing operations
  • Verification that your formulation, manufacturing or processing methods and analytical methods are consistent with the descriptions contained in the CMC section of the application to establish product equivalency of the biobatch (and other pivotal clinical batches, when applicable), the proposed commercial scale batch and the API
  • Authentication of the raw data, such as chromatographs, spectograms, laboratory analyst notebooks and additional laboratory data by comparison with data filed in the CMC section of the application to verify that the CDER reviewers can rely on the submitted data as complete and accurate
  • Verification that Manufacturing and laboratory changes, deviations and trends relating to the development of the new drug substance and product manufacturing have been adequately evaluated
  • Ensuring that a sound and appropriate program for sampling, testing and evaluation of components, including in-process materials, finished products, containers and closures for the purpose of releasing materials or products has been established, including a robust supplier qualification program
  • Verifying that sufficient facility and equipment controls are in place to prevent contamination of and by the application product (or API)
  • Confirming that adequate procedures exist for batch release, change control, investigating failures, deviations, complaints and adverse events; and for reporting this information to the FDA
  • Evaluating the feasibility of the proposed commercial process and manufacturing batch record, including instructions, process parameters and process control measures and ensuring that they are scientifically and objectively justified.


  • 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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