Print Edition - Preparing for an FDA Preapproval Inspection

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October 2011
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What factors does the FDA consider when it decides to conduct a preapproval inspection of a drugmaker, and what can you do to minimize the chances of being selected?

What special areas of emphasis will FDA focus on during a preapproval inspection?

How do you — and your partners — need to prepare for these inspections?

Any company submitting a new drug application or major supplement to an existing application can be chosen for a preapproval inspection. These inspections can trip up even experienced drugmakers, and the consequences are painful: delays in manufacturing, liability issues, splashover effects on other products, and damage to a firm’s reputation.

Now’s the time to prepare for a preapproval inspection.

This report from FDAnews takes you step by step through how to prepare for and how to conduct yourself during — and after — the critical preapproval inspection.

By taking the mystery out of what to expect, the report gives you far more power to make sure everything is in order, from records to cGMPs. Plus, you’ll learn how to reduce your chances of even having a preapproval inspection.

Buy now to get to market as fast as possible by answering the right questions, including:

  • Is your company a likely target for a preapproval inspection — and what can you do to reduce your chances of being inspected?
  • How does working with CMOs and partners affect you during the preapproval inspection process?
  • What troubleshooting must you do long before inspectors arrive?
  • What records will inspectors want to review — and what rights does the inspector have during the inspection?
  • What areas of your operations are likely to receive special attention?
  • How should you operate during the actual inspection?
  • How should — and shouldn’t — onsite personnel interact with inspectors?
  • How should you handle disagreements with the FDA over issues raised during the preapproval inspection?
  • And more

Remember: the preapproval inspection isn’t just an ordinary inspection. It’s the FDA’s first chance to determine the manufacturing quality for your drug product.

A smooth inspection not only helps you get to market sooner, it helps set the tone for future inspections of this and other products your company manufactures. Let this report help you prepare effectively.

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