| Validation and Qualification in Analytical Laboratories Contributor(s): Huber, Ludwig (Author) |
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ISBN: 084938267X ISBN-13: 9780849382673 Publisher: CRC Press OUR PRICE: $218.50 Product Type: Hardcover - Other Formats Published: July 2007 Annotation: 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. |
| Additional Information |
| BISAC Categories: - Medical | Pharmacology - Science | Chemistry - Analytic |
| Dewey: 543.068 |
| LCCN: 2007020360 |
| Physical Information: 0.85" H x 6.39" W x 8.99" (1.20 lbs) 288 pages |
| Descriptions, Reviews, Etc. |
| Publisher Description: 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. |