Validation and Qualification in Analytical Laboratories

By Ludwig Huber and Huber Huber

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.

• Format: Hardcover
• Language: English
• ISBN: 084938267X
• ISBN13: 9780849382673
• Release Date: July 2007
• Publisher: CRC Press
• Length: 314 Pages
• Weight: 1.60 lbs.
• Dimensions: 0.8" x 6.4" x 9.0"