Validation and Qualification in Analytical Laboratories

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.

Author: Ludwig Huber
Publisher: CRC Press
Published: 07/23/2007
Pages: 314
Binding Type: Hardcover
Weight: 1.20lbs
Size: 8.99h x 6.39w x 0.85d
ISBN: 9780849382673