Author: MTS

New Guidelines: ICH Q2(R2) and Q14

The Assembly of the ICH met in-person in Prague on 31 October & 1 November 2023. The revised guideline on “Validation of Analytical Procedures”, ICH Q2(R2), and the new guideline on “Analytical Procedure Development”, ICH Q14, reached Step 4 and were adopted by the ICH Assembly Regulatory Members. The final versions of both guidelines are […]

ICH Updates in Our Validation Courses

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 […]