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What is Analytical Procedure Lifecycle Management about?
This document discusses the lifecycle management of analytical procedures, including method development, procedure performance qualification, and procedure performance verification. It emphasizes understanding and controlling sources of variability throughout the analytical procedure lifecycle to ensure reliable and consistent results. Key aspects include defining acceptance target profiles, risk-based approaches to identifying and evaluating critical variables, experimental design of studies, and knowledge
- Author
- Nur Acar
- Language
- EN