Overview
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.
This item is Non-Returnable
Customers Also Bought
Details
- ISBN-13: 9780849382673
- ISBN-10: 084938267X
- Publisher: CRC Press
- Publish Date: July 2007
- Dimensions: 8.99 x 6.39 x 0.85 inches
- Shipping Weight: 1.2 pounds
- Page Count: 314
Related Categories
