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General Industry |
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Pharmaceutical
Pre-Approval Inspections
Publication Date March 2008
Publisher Informa Healthcare
Product Type Report
Pages 356
ISBN Number 9780849391842
Product Code IFH00017
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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.
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Content
- 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
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