Validation and Qualification in Analytical Laboratories, Second Edition

Learn how to improve pharmaceutical product quality and achieve compliance with global regulatory standards. This text provides step-by-step instructions, practical recommendations, standard operating procedures (SOPs), checklists, templates, and graphics for easy incorporation in a laboratory. It also explains how to develop and implement a validation strategy for routine, nonroutine, and standard analytical methods, covering the equipment, hardware, and software qualification process. Also included is advice on qualification of certified standards, in-house reference materials, people qualification, and internal and third party laboratory audits and inspections.