Validation and Qualification in Analytical Laboratories

This Second Edition discusses ways to improve pharmaceutical product quality while achieving compliance with global regulatory standards.
2019-04-13 Pharmaceutical Validation Book or Program 514 views Editor: Mohamed Atia


Validation and Qualification in Analytical Laboratories 2nd Edition

by Ludwig Huber (Author)

Publisher: CRC Press; 2 edition (July 23, 2007)
Language: English
ISBN-10: 084938267X
ISBN-13: 978-0849382673

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.

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