Validation And Qualification In Analytical Laboratories

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    Validation and Qualification in Analytical Laboratories
    By: Ludwig Huber
    Publisher:
    routledge
    Print ISBN: 9780849382673, 084938267X
    eText ISBN: 9780849382680, 0849382688
    Edition: 2nd
    Copyright year: 2007
    Format: PDF
    Available from $ 23.18 USD
    SKU 9780849382680R90
    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.
    Additional ISBNs
    9781280930034, 9780849382680, 1280930039, 0849382688
     

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