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Image of - Validation and Qualification in Analytical Laboratories | 2nd Edition | Hardcover
Validation and Qualification in Analytical Laboratories | 2nd Edition | Hardcover

Validation and Qualification in Analytical Laboratories | 2nd Edition | Hardcover

by Huber

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.

Highlights

  • binding-icon

    9780849382673

    ISBN:

  • binding-icon

    Huber

    Author:

  • binding-icon

    288

    Pages:

  • binding-icon

    210 gm

    Weight:

  • langauage-icon

    English

    Language:

  • date-icon

    2007

    Year:

  • edition-icon

    2nd Edition

    Edition:

  • binding-icon

    Hardcover

    Binding:

3996

4995

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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