Validation and Qualification in Analytical Laboratories
Language: English
Published by CRC Press, 2007
- Softcover
- Used
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- Title
- Validation and Qualification in Analytical Laboratories
- Author
- Huber, Ludwig
- Publisher
- CRC Press
- Publication year
- 2007
- Condition
- Good
- Binding
- Paperback
- Language
- English
- ISBN 10
- 084938267X
- ISBN 13
- 9780849382673
- Edition
- 2nd Edition
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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