Draft versions of the revision of ICH Q2, Validation of Analytical Procedures, and also the new guideline Q14, Analytical Procedure Development, were published on the 24th March 2022. We have modified our courses, ‘Validation, Verification & Transfer of Methods for Pharmaceutical Analysis,’ and, ‘Validation, Verification & Transfer of Methods for Biopharmaceutical Analysis‘, to ensure that attendees are completely ready for the introduction of the new version of the Q2 (R2) guideline and are familar with the new Q14 guideline and how it relates to method validation.
Although this guidance is still in a draft status, and thus may not be the same in the finalised document, many of the new features are good advice even if they don’t end up in the final version.