Validation and Qualification in Analytical Laboratories

2nd Edition

Ludwig Huber

CRC Press
Published July 23, 2007
Reference - 288 Pages - 48 B/W Illustrations
ISBN 9780849382673 - CAT# DK8267

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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.