Quality Analysis for Life
The data generated by analytical science are crucial to pharma decision making – so let’s adopt a lifecycle management approach to method development to ensure continued excellence.
Paula Hong, Antonio Ramos | | Opinion
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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