ICH Q14 is primarily intended to support applicants in not submitting analytical validation results in isolation but in presenting them together with a present performance evaluation based on corresponding analytical development results. This applies in particular to modern analytical methods. ICH Q14 should offer harmonized scientific approaches for analytical method validation as well as support the communication between authorities and industry.
Furthermore, the Expert Working Group for this task shall potentially determine the feasibility to combine both documents into one for simplification and clarity.
Draft documents should be available in spring 2020. Final versions are supposed to follow in spring 2021.
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