What do you need to know and do prior to your pre-approval inspection?
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 — $177
Who Will Benefit
Research and development staff
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