Analytical Method Validation in Pharma: ICH Q2(R2), Accuracy, Precision, Linearity, LOD & LOQ
Published by: Pharma Quality System Editorial Team • Editorial basis: ICH Q2(R2), ICH Q14, FDA laboratory controls, and Health Canada ICH implementation ICH Q2(R2) • Q14 • HPLC • QC LABORATORY Analytical method validation demonstrates that an analytical procedure is fit for its intended purpose. Under ICH Q2(R2), validation is linked more explicitly with analytical procedure development, lifecycle knowledge, risk and the performance characteristics needed for the intended analytical use. Quick answer Analytical method validation is not a fixed checklist where every characteristic is always required. The design depends on the intended analytical purpose . Common characteristics include specificity/selectivity, accuracy, precision, response/linearity where appropriate, range, detection limit, quantitation limit and robustness. Current regulatory point: FDA finalized ICH Q2(R2) and Q14 in March 2024. Health Canada implemented Q2(R2) on October 17, 2025 and Q14...