Introduction to Analytical Procedure (Method) Lifecycle Management
12 Mar 2019The Method Lifecycle Management (MLCM) approach is a holistic approach encompassing all activities, from method development to validation, routine use, change control and retirement of the method. This enhanced approach improves the method understanding and performance, leads to fewer out-of-specifications results (OOS), facilitates method transfer and has the potential to lessen the regulatory burden.
These slides showcase the higlights of a webinar presented by Dr. Horacio Pappa, Director of General Chapters, United States Pharmacopeia, and Dr. Alexander Schmidt, Founder and CEO, and Mijo Stanic, Cofounder, General Manager and Technical Director, Chromicent Pharmaceutical Services, that contains the method lifecycle management key concepts, its benefits to drug manufacturers and patients, and the current thinking of the United States Pharmacopeia (USP), U.S. Food and Drug Administration (FDA) and ICH.
