ICH Q2
Validation of Analytical Procedures
International standard for proving an analytical method does what it claims — specificity, accuracy, precision, linearity, range, LOD, LOQ, robustness.
ICH Q2(R2) (2023 revision) defines the validation characteristics that must be demonstrated for analytical procedures used in pharmaceutical QC and stability testing: specificity, accuracy, precision (repeatability + intermediate precision), detection and quantitation limits, linearity, range and robustness. R2 extended scope to cover multivariate methods and method lifecycle (with ICH Q14).
Method validation evidence sits behind every release CoA and every OOS investigation — without it, an analyst cannot defend a result against an FDA or EMA inspector.
- ICH Q2(R2)
- ICH Q14
- USP <1225>
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