Pharmaceutical

Summary

This Second Edition is an essential guide to preparing for inspections-taking into account current trends in FDA expectations and enforcement activities, such as quality systems-based approach to inspections, risk-based inspections, and the GMPs of the 21st century to produce rapid regulatory approval.

Contents

• 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 21st 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 in Light of Recent Trends
• Computer Validation Systems Validation during the Drug Development Process
• The Use of Audits during the Drug Development Process to Assure a Successful Pre- Approval Inspection
• The Consequence of a Poor Product Development Process and Failing a Pre-Approval Inspection