Validation and qualification: the fitness for purpose of mass spectrometry-based analytical methods and analytical systems

The context of validation for mass spectrometry (MS)-based methods is critically analysed. The focus is on the fitness for purpose depending on the task of the method. Information is given on commonly accepted procedures for the implementation and acceptance of analytical methods as ‘confirmatory methods’ according to EU criteria, and strategies for measurement. Attention is paid to the problem of matrix effects in the case of liquid chromatography-mass spectrometry-based procedures, since according to recent guidelines for bioanalytical method validations, there is a need to evaluate matrix effects during development and validation of LC-MS methods “to ensure that precision, selectivity and sensitivity will not be compromised”. Beneficial aspects of the qualification process to ensure the suitability of the MS analytical system are also evaluated and discussed.