ICH Q14: Stockholm Symposium Discussion

The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use issued draft guidance on ICH Q14 in March 2022. This guidance describes science and risk-based approaches for developing and maintaining analytical methods suitable for the assessment of the quality of drug substances and drug products, which incorporates traditional Quality by Design principles into CMC analytical development. Given the imminent release of ICH Q14 and its expected impact on analytical method development approaches, Dr. Rachel Smith, Assay Development Scientist for Labcorp Biopharm CMC Services, discussed our interpretation and implications of ICH Q14 in April 2023 during live scientific symposium. This is a recording of that discussion.