Validation and Qualification in Analytical Laboratories, 2nd edition

Summary

This Second Edition explains how to improve pharmaceutical product quality while achieving compliance with global regulatory standards. With comprehensive step-by-step instructions, practical recommendations, standard operating procedures (SOPs), checklists, templates, and graphics for easy incorporation in a laboratory, this title serves as a complete source to the subject and explains how to develop and implement a validation strategy for routine, non-routine, and standard analytical methods, covering the entire equipment, hardware, and software qualification process. It also provides guidance on qualification of certified standards and in-house reference materials and people qualification, as well as internal and third party laboratory audits and inspections.

Contents

• Regulations and Quality Standards
• Terminology
• Design Qualification
• Installation Qualification
• Operational Qualification
• Performance Qualification
• Validation of Software and Computer Systems
• Validation of Analytical Methods
• Validation of Data
• Qualification of Reference Standards
• People Qualification
• Proficiency Testing
• Auditing Laboratories
• Risk Based Validation and Qualification
• Corrective and Preventive Action Plans for Laboratories
• Appendix A Glossary
• Appendix B Testing
• Appendix C Sops
• Appendix D Case Study
• Appendix E Literature References