The lifecycle of analytical procedures, also known as analytical methods, for pharmaceutical development and manufacture depends on the reliability, robustness, and accuracy of analytical measurements.
Method Lifecycle Management Library
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Method lifecycle management (MLCM) provides an opportunity to continuously improve and ensure quality of data through the application of quality risk management.
The modern concept of method lifecycle management (MLCM) provides a framework for defining the criteria and development of analytical methods, aiming to give a more structured alternative to analytical method development.
Since July 2018, the pharmacological class of "sartans" has been the subject of considerable media and analytical interest, as it became known that they are contaminated with nitrosamines such as N-nitrosodimethylamine (NDMA), N-nitrosodiethylamine (NDEA) and N-nitrosodiisopropylamine (NDiPA).