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What do you need to know and do prior to your pre-approval inspection?
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Everything rides on your ability to support the claims you made in your new drug application — especially when it comes to the data underpinning the Chemistry, Manufacturing and Controls section.
Would a step-by-step guide come in handy?
You need to have the right answers to 3 key questions FDA investigators will ask during your pre-approval inspection:
- Is your facility ready for commercial manufacturing?
- Can you meet the commitments and specifications laid out in your application?
and, most important of all ...
- Are your data and data collection methodology reliable?
You can answer yes, by following the 4 key steps outlined in Pre-Approval Inspection: Four Steps to Success:
- Verify application integrity: Make sure your development data and operations are adequate to support the application
- Verify GMP compliance: Confirm that your company is meeting all the rules
- Prepare to host the FDA inspection: Train your staff to interact appropriately with investigators
- Perform mock inspections: Identify gaps and weaknesses and correct them before investigators spot them
This FDAnews Brief gives you a concise, point-by-point map to follow to pre-approval success, from developing an inspection SOP to making logistical decisions to handling investigators questions effectively, and surviving the data integrity audit.
A smooth pre-approval inspection not only helps you get to market sooner, it helps set the tone for future GMP inspections you will face. Order your copy of Pre-Approval Inspection: Four Steps to Success today.
PDF Edition
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PDF Edition — $177
Who Will Benefit
- Quality lead
- Research and development staff
- Regulatory affairs
- Production supervisors
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