Validation and Qualification in Analytical Laboratories: 2nd Edition (Hardback) book cover

Validation and Qualification in Analytical Laboratories

2nd Edition

By Ludwig Huber

CRC Press

288 pages | 48 B/W Illus.

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Hardback: 9780849382673
pub: 2007-07-23
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eBook (VitalSource) : 9780429191220
pub: 2007-07-23
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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.


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

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

Subject Categories

BISAC Subject Codes/Headings:
MEDICAL / Pharmacology
SCIENCE / Chemistry / General