Each test method — analytical or biochemical — must be appropriately validated against ICH requirements, under which methods are classed as assay, identity, or impurity tests. Each method requires a documented assessment on its accuracy, precision, repeatability, specificity, detection limit, quantitation limit, linearity, range defined in validation activities, validation protocols and reported in validation reports.
Regulatory agencies espouse the importance of a robust and well-documented analytical development strategy by their acceptance of biochemical bridging for post-marketing activities, such as comparability protocols and/or equivalence protocols in support of process changes and technology transfer activities.
The evolution and derivation of the selected test methods (and the omission of other methods) must be documented as part of the licence submission package both at clinical trials/IND application and at MAA stages. A detailed justification of the test specifications must be provided as part of any submission package justifying the inclusion and exclusion criteria for tests.