Validation

{
  "id": "MLC-T-CHM-012504",
  "term": "Validation",
  "field": "Chemistry",
  "definition": "Documented confirmation, resting on objective evidence, that a method, process or system meets the requirements of the use it is intended for. For an analytical method it means showing by experiment that the procedure is fit for its purpose, by evaluating characteristics such as trueness, precision, linearity, detection limit and robustness. Regulatory guidance such as ICH Q2 sets out the validation characteristics expected for methods used in pharmaceutical quality control.",
  "subject": "Analytical Chemistry",
  "see_also": [
    "determination",
    "procedure validation",
    "requirement",
    "testing"
  ],
  "references": [
    "PAC, 2021, 93, 997. 'Metrological and quality concepts in analytical chemistry (IUPAC Recommendations 2021)' on page 1043 (https://doi.org/10.1515/pac-2019-0819)"
  ],
  "url": "https://mlchart.com/terminology/chemistry/validation/"
}