Evolution of ICH Q2 guideline (Validation of Analytical Procedures)

Time for an update


What’s new?

In many areas the new document remains unchanged from ICH Q2(R1) and is true to the principles given in that guidance. However, there are some areas that have been developed and serve to give clarification to what is expected.

As an example, the document now has useful annexes which cover a variety of methods from Binding Assays to Quantitative LC/MS. This is of course not an exhaustive list but does serve to provide useful guidance for how to handle a variety of scenarios. These examples clarify expectations for the various aspects of a qualification/validation study, something that was lacking in Q2(R1).




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