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. . Language: English