A Guide to Regulatory Success
Second edition
edited by Martin D. Hynes III
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
- The Evolution of the Food and Drug Administration: Pre-New Druig Application Approval Inspection
- FDS's Risk-Based Approach to Inspections
- Critical Role of the Pharmaceutical Scientist in Product Development and Preparing for Pre-approval Inspections
- Training Requirements in Product Development: A Key to a Successful Pre-Approval Inspection
- A cGMP Risk Assessment and Management Strategy: Guidelines for the Pre-Approval Inspection
- Concepts in Quality by Design for Drug Development and Manufacture
- Equipment Cleaning During Pharmaceutical Product Development and Its Importance to Pre-Approval Inspection
- Conducting Stability Studies During Development to Ensure Successful Regulatory Approval
- Computer Systems Validation During the Drug Development Process in Anticipation of Pre-Approval Inspections
- Integral for Successful PAI: The Quality Assessment Program
- All Dressed Up but No Approval to Go: The Consequence of Failing an FDA Pre-Approval Inspection
Index