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Regulation & Policy

Validation and Qualification in Analytical Laboratories, 2nd edition

 

Publication Date August 2007
Publisher Informa Healthcare
Product Type Book
Pages 214
ISBN Number 978-0-8493-8267-3
Product Code IFH00185

Price

£130.00
approximately: $197 | €145

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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