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Validation and Qualification in Analytical Laboratories
Hardcover
ISBN13: 9780849382673
Publisher: Crc Pr Inc
Published: Jul 23 2007
Pages: 314
Weight: 1.20
Height: 0.85 Width: 6.39 Depth: 8.99
Language: English
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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