The Preapproval Inspection: Passing the FDA’s GMP Test
Even if you’ve passed the FDA’s previous preapproval inspections (PAIs), you’ll be challenged going forward. The FDA has updated its PAI procedures, increasing the risks for your manufacturing operations and making it less likely your new drug application (NDA) or abbreviated new drug application (ANDA) will be approved.
The new PAIs go well beyond a typical good manufacturing practices (GMP) inspection. Now the FDA’s objectives are more highly targeted. Failing a PAI brings your drug development program to a halt. Even the best, most-needed products won’t get made if FDA investigators find problems in your manufacturing operations.
The Preapproval Inspection: Passing the FDA’s GMP Test management report will show you how to review your GMP compliance for gaps; review your FDA application with an eye for what agency investigators will look for; conduct a mock PAI to train staff to handle the real thing; how the FDA trains its inspection teams to conduct PAIs; what happens after the PAI, including responding to a Form 483; and how the FDA makes the decision to approve — or withhold approval — based on PAI findings.
This report provides all the information you need to handle a PAI successfully, explaining:
- The four steps to preapproval inspection (PAI) preparation
- The FDA’s three PAI objectives
- How to develop a PAI standard operating procedure (SOP)
- What FDA investigators can do and see during an inspection
- How to respond to a Form 483
- How to conduct a mock inspection
- The do’s and don’ts of handling a PAI
It also includes the FDA Compliance Program Guidance Manual on how agency investigators should conduct PAIs, a mock inspection checklist and a checklist for developing a PAI SOP.
If you’re preparing to submit an NDA or ANDA, you’ll need The Preapproval Inspection: Passing the FDA’s GMP Test to prove that your manufacturing operation can produce a safe, high-quality drug product.
Who Will Benefit
- Quality department staff
- Regulatory affairs personnel
- Operations/manufacturing staff
- R&D personnel
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