Whether preparing for regulatory submissions or preapproval, investigator-directed, routin, or foreign inspection, this reference is assured to enhance the facility- and compliance-readiness of any company requiring a strengthened approach to compliance and total quality management.

Providing innovative programs for every key quality system within an FDA environment, this guide evaluates critical compliance and quality challenges within the context of FDA expectations, current industry standards, and emerging global trends.

• Lists the necessary steps for meeting compliance requirements during the drug development process

• Presents comprehensive approaches for validating analytical methods for pharmaceutical applications

Contents

1. Regulatory Submissions
2. Compliance Requirements During the Drug Development Process
3. Validation – A New Perspective
4. Validating Analytical Methods for Pharmaceutical Applications: A Comprehensive Approach
5. The Stability Testing Program
6. Computer Validation: A Compliance Focus
7. Compliance Issues Associated with Cleaning in the Pharmaceutical Industry
8. The Batch Record: A Blueprint for Quality and Compliance
9. Change Management: A Far Reaching, Comprehensive, and Integrated System
10. The Vendor Qualification Program
11. Handling Laboratory and Manufacturing Deviations
12. The Internal Audit Program: A Quality Assessment
13. Pre-Approval Inspections: The Critical Compliance Path to Success
14. International Compliance Issues and Trends
15. Strategic Planning for Compliance and Regulatory Defensiveness
16. Unique and Unprecedented Compliance Challenges in the Biologics Area
17. The Impact of Total Quality Performance on Compliance

Index

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