Application of ICH Q14 principles to potency assay development

CASSS Bioassays 2024 -- ICH Q14 is a new guideline on analytical procedure development that will come into effect on 14 June 2024, and compliments a revision update (R2) of ICH Q2 Validation of Analytical Procedures - Scientific Guideline. It was implemented due to the number of observations relating to deficiencies in data supporting CMC analytical procedure development, robustness testing and validation. ICH Q14 aims to provide a framework of advice on what is expected in a regulatory submission in support of Analytical Procedures to demonstrate phase-appropriate suitability across the assay lifecycle.