Validation and Qualification in Analytic
β Ludwig Huber
π Library
π
2007
π English
β¦ LIBER β¦
π
Validation and Qualification in Analytical Laboratories
β Scribed by Huber Ludwig
- Publisher
- Informa Healthcare
- Year
- 2007
- Tongue
- English
- Leaves
- 314
- Edition
- 2
- Category
- Library
β¬ Acquire This Volume
No coin nor oath required. For personal study only.
β¦ Synopsis
This Second Edition explains how 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 and in-house reference materials and people qualification, as well as internal and third party laboratory audits and inspections.
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