Validation And Qualification In Analytical Laboratories 2nd Edition Huber Ludwig by Huber Ludwig 9780849382673, 084938267X instant download after payment.

This Second Edition explains how 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 and in-house reference materials and people qualification, as well as internal and third party laboratory audits and inspections.