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Validation and Qualification in Analytical Laboratories|Ludwig Huber

Validation and Qualification in Analytical Laboratories

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Overview

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.

This item is Non-Returnable

Details

  • ISBN-13: 9780849382673
  • ISBN-10: 084938267X
  • Publisher: CRC Press
  • Publish Date: July 2007
  • Dimensions: 8.99 x 6.39 x 0.85 inches
  • Shipping Weight: 1.2 pounds
  • Page Count: 314

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