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Discovery & Development Analytical Science

Quality Analysis for Life

For a method to yield reliable, reproducible results over time, it must remain robust throughout the entire lifecycle. The concept of lifecycle management for ensuring the quality of pharmaceutical products is well understood, and has now inspired a relatively more modern concept: method lifecycle management (MLCM). MLCM provides a framework for defining the criteria for and development of analytical methods. Ultimately, this should lead to a more structured and scientific approach to analytical method development (1).

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About the Authors

Paula Hong

Principal Consulting Scientist at Waters Corporation


Antonio Ramos

Principal Analytical Chemist in Analytical Development at Hovione

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