Validation and Qualification in Analytical Laboratories, Second Edition

Download or read book Validation and Qualification in Analytical Laboratories, Second Edition written by Ludwig Huber and published by CRC Press. This book was released on 2007-07-23 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.