ICH Q14 guideline on analytical procedure development

The ICH Q14 guideline on Analytical procedure development will be effective from June 2024.

This guideline describes science and risk-based approaches to developing and maintaining analytical procedures suitable for assessing the quality of drug substances and drug products. This guideline complements ICH Q2 Validation of Analytical Procedures.
It also describes the submission of information on the development of analytical procedures and their related life cycle in the Common Technical Document (CTD) format.

More info : https://www.ema.europa.eu/en/ich-q14-analytical-procedure-development-scientific-guideline