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Item Details
Title: VALIDATION AND QUALIFICATION IN ANALYTICAL LABORATORIES, SECOND EDITION
By: Ludwig Huber
Format: Electronic book text

List price: £122.00


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ISBN 10: 0849382688
ISBN 13: 9780849382680
Publisher: TAYLOR & FRANCIS INC
Pub. date: 23 July, 2007
Edition: 2nd New edition
Pages: 288
Synopsis: 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.
Illustrations: 37 Tables, black and white; 48 Illustrations, black and white
Publication: US
Imprint: CRC Press Inc
Returns: Non-returnable
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