Pre-Approval Inspection Audits
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 unfavourable PAI results can cost millions of dollars.
FDA may approve a New Drug Application (NDA), an abbreviated New Drug Application (ANDA) or a Biologic Licensing Application (BLA) provided the PAI confirms that the methods used in, and the facilities and controls used for, the manufacture, processing, packaging and testing of the drug are adequate and ensure and preserve its identity, strength, quality and purity.
USDM's industry experts can enhance your readiness and probability of successfully passing the FDA PAI and facilitating approval of your submission and license to manufacture your new drug substance by providing the following readiness assessment services:
- Evaluation & determination of your risk of being classified as a priority or discretionary PAI candidate
- Profile class assessment
- Risk assessment and prioritization of contract manufacturing organizations (CMOs)
- CGMP, ICH Q7A and Pre-PAI audits, readiness assessments and remediation
- 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 determining whether 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.
Watch this complimentary and informative webinar recording to learn more about how USDM's team of experts can assist you with Pre-PAI readiness assessments to ensure that your responsibilities as drug sponsor/owner are effectively discharged and you avoid findings and observations associated with withholding your PAI approval.
To learn more about USDM and how we can assist with your specific compliance and business objectives, please contact:
Rebecca Meledy
888.231.0816 x161
775.213.5943 (fax)
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