Preparing for FDA Pre-Approval Inspections: A Guide to Regulatory Success, Second Edition [Paperback]

This Second Edition is an essential guide to preparing for FDA pre-approval inspectionstaking 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

Introduction/Preface.? Pre-Approval Inspection: A Historical Overview.? Recent Trends in Domestic and International Pre-Approval Inspections.? The Implications of the Quality Systems, Risk Based Inspections and 21^st Century GMPs to Preparing for FDA Pre-Approval Inspections.? Preparing for FDA Pre-Approval Inspections Similarities and Differences between Center for Biologics Evaluation and Research (CBER) / Center for Drug Evaluation and Research (CDER).? The GMP Risk Assessment, Guidance for Preparing for Pre-Approval Inspections, Traditional and Non-Traditional.? The Product Development Drill, the Importance of Good Science, Stability Data, Scale Up, and Validation to Successfully Passing a Pre-Approval Inspection.? The History of Development Documents: Guidance for Preparation lóç