Validation and Qualification in Analytical Laboratories
| Autor: | Huber, Ludwig |
|---|---|
| EAN: | 9780849382673 |
| Auflage: | 002 |
| Sachgruppe: | Medizin |
| Sprache: | Englisch |
| Seitenzahl: | 314 |
| Produktart: | Gebunden |
| Veröffentlichungsdatum: | 23.07.2007 |
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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.
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