European Bioanalysis Forum recommendation on embracing a context-of-use-driven scientific validation for chromatographic assays in the light of ICH M10.

Abstract

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use M10 guideline provides a global framework for bioanalytical method validation in studies intended for regulatory submission. While its structure ensures consistency and data reliability, the guideline also acknowledges that not all studies require the same level of validation. This paper examines where full compliance is essential and where scientific judgment allows for leaner, context-driven validation, such as in early-stage development, for additional matrices, metabolites, nonstandard biological matrices or studies intended for internal decision-making. Drawing on recent recommendations from the European Bioanalysis Forum, we introduce a decision-making flowchart and parameter table to support consistent application of a Context-of-Use approach to validation. These tools help guide when flexibility is appropriate while ensuring transparency and robustness in the data. The paper advocates continued dialogue both with end users of the data and the regulatory authorities to support a modernized, risk-based validation framework that remains aligned with patient needs and scientific integrity. We believe the recommendations in this paper are fully in alignment with the intent and core principles of ICH M10, while encouraging their application in a way that remains scientifically driven and proportionate to the purpose of the assay.