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Validation and Qualification in Analytical Laboratories, Second Edition, by Ludwig Huber
Fee Download Validation and Qualification in Analytical Laboratories, Second Edition, by Ludwig Huber
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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.
- Sales Rank: #937413 in Books
- Published on: 2007-07-23
- Original language: English
- Number of items: 1
- Dimensions: 8.99" h x .85" w x 6.39" l, 1.24 pounds
- Binding: Hardcover
- 288 pages
Most helpful customer reviews
0 of 1 people found the following review helpful.
Completes first edition
By Beno HarKochav
For many years i had the first edition of this book. This one seems to be updated, but the core of the work still stands the same to the first edition. In any case, this edition has been printed in a smaller size and one can go arround with the book anywhere.
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