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International Conference on Harmonisation Validation Criteria

المؤلف:  Sue Jickells , Adam Negrusz (Editors)

المصدر:  Clarkes Analytical Forensic Toxicology

الجزء والصفحة:  411

2026-11-09

29

International Conference on Harmonisation Validation Criteria

The main objective of validation of an analytical procedure is to demonstrate that the procedure is suitable for its intended purpose. The objective of an analytical procedure should be understood clearly, since this will govern the validation char act eristics that need to be evaluated. Typical valid ation characteristics that should be considered according to the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) are:

• accuracy

• precision (repeatability and intermediate precision)

• specificity

• detection limit

• quantification limit

• linearity and range.

All these characteristics are also listed and explained in the USP 30 (USP 2007). For the quantitative determination of impurities, all these criteria should be evaluated, while for limit tests the specificity and detection limit are most relevant. For assays, all characteristics except detection limit and quantification limit are normally evaluated. For linearity, the ICH recommends a minimum of five concentrations to be measured.