Date: March 2024
FDA’s Center for Drug Evaluation and Research issued ICH Q2(R2), Validation of Analytical Procedures, and the companion ICH Q14, Analytical Procedure Development, as final guidance in March 2024. Q2(R2) replaces the 2005 text with a broader framework that covers the reportable range, calibration model selection, and the validation of spectroscopic and multivariate procedures, and ties validation to the procedure’s intended use.
What it means for calibration
Q2(R2) expects the calibration model to be justified, not assumed: the response relationship, the weighting and the range are chosen from data and documented, and accuracy is demonstrated across the range rather than inferred from a correlation coefficient. For pharmaceutical QC labs that means the model decision belongs in the validation record and the routine calibration has to be shown to hold it. Together with ICH M10 for bioanalysis, this is the text FDA auditors will cite when they ask why a curve was fitted the way it was.
Source: fda.gov, Q2(R2) Validation of Analytical Procedures (final guidance, March 2024)
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