Pharmaceutical Pre-Approval Inspections Second edition is an essential guide to preparing for FDA pre-approval inspections—taking into account current trends in FDA expectations and inspection activities, such as:

• the GMPs of the 21st Century
• quality systems-based approach to inspections
• risk-based inspections
• quality by design
• process analytical technology
• design space, etc.

The goal of this book is to help organizations gain rapid regulatory approval.

Pharmaceutical Pre-Approval Inspections: A Guide to Regulatory Success, Second Edition

• chronicles the major shifts in inspection activity as evidenced by a systems-based approach to inspections
• demonstrates what each area of pharmaceutical development, from research and development to training, is expected to provide to inspectors
• focuses on traditional development and submission activities, but also discusses cases where the transfer is from a domestic site to an international facility

Contents

1. The Evolution of the Food and Drug Administration: Pre-New Druig Application Approval Inspection
2. FDS's Risk-Based Approach to Inspections
3. Critical Role of the Pharmaceutical Scientist in Product Development and Preparing for Pre-approval Inspections
4. Training Requirements in Product Development: A Key to a Successful Pre-Approval Inspection
5. A cGMP Risk Assessment and Management Strategy: Guidelines for the Pre-Approval Inspection
6. Concepts in Quality by Design for Drug Development and Manufacture
7. Equipment Cleaning During Pharmaceutical Product Development and Its Importance to Pre-Approval Inspection
8. Conducting Stability Studies During Development to Ensure Successful Regulatory Approval
9. Computer Systems Validation During the Drug Development Process in Anticipation of Pre-Approval Inspections
10. Integral for Successful PAI: The Quality Assessment Program
11. All Dressed Up but No Approval to Go: The Consequence of Failing an FDA Pre-Approval Inspection

Index

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