ICH Q2(R2): Validation of Analytical Procedures

International guideline on the validation of analytical procedures. Defines criteria such as specificity, accuracy, precision and linearity.

Key points

• An analytical procedure must be demonstrably fit for its purpose.
• Core validation parameters are specificity, accuracy, precision, range and detection limits.
• The revised version also covers modern approaches such as multivariate methods.

Assessment

The guideline comes from pharmaceutical regulation. We use it as a yardstick for what makes a good test method and disclose which methods our batches are tested with. See Methodology.