Validation and Qualification in Analytical Laboratories  book cover
2nd Edition

Validation and Qualification in Analytical Laboratories

ISBN 9780849382673
Published July 23, 2007 by CRC Press
288 Pages 48 B/W Illustrations

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Book Description

This Second Edition discusses ways 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, in-house reference materials, and people qualification, as well as internal and third party laboratory audits and inspections.

Table of Contents

Regulations.  Terminology.  Risk Assessment.  Master and Project Planning.  Design Qualification.  Installation Qualification.  Operational Qualification.  Performance Qualification.  Software and Computers.  Validation.  Data Review.  Out-of-Specifications.  Certified Reference Standards.  People.  Proficiency Testing.  Audits.  Appendix A: Glossary.  Appendix B: Testing.  Appendix C:  SOP.  Appendix D: Books.  Appendix E: References

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a great single reference containing all you ever wanted to know about validating and verifying assay or equipment performance.
Doody’s Review - Valerie L.  Ng, PhD, MD