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 expected soon on the ICH website.

MTS is offering a new short course relating to these updates, ‘What’s New in ICH Q2(R2) and Q14?‘, which will fully explore the updates to Q2 in terms of the additional information that has been introduced, and the expected benefits, the potential additional validation requirements and associated gap assessment, when compared to previous requirements, and also to provide an overview of the contents of Q14 and how this new guideline relates to Q2(R2).

Our existing courses, ‘Validation, Verification and Transfer of Methods for Pharmaceutical Analysis‘; and ‘Validation, Verification and Transfer of Methods for Biopharmaceutical Analysis‘, have been updated to include all of the relevant content from both guidelines. They provide a complete treatment of analytical procedure lifecycle management in a pharmaceutical/biopharmaceutical analysis setting.

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