Analytical method validation

Demonstrating that an analytical procedure is fit for its intended purpose, following ICH Q2(R2), with method development described in ICH Q14. Typical characteristics are specificity, accuracy, precision (repeatability, intermediate precision, reproducibility) and range, plus detection and quantitation limits for impurity tests. Japanese reports use fixed Japanese terms for these, for example accuracy (真度), repeatability (併行精度) and intermediate precision (室内再現精度). Since August 2021 a change to a test method in the Japanese approval can be filed as a minor change notification, but only with a reasonable basis that analytical performance is unaffected, so validation data now help decide the filing route.