Procedure validation
Term · Chemistry · MLC-T-CHM-009491
The process of confirming by examination and objective evidence that a specific analytical procedure is fit for its intended purpose. This involves systematically evaluating performance characteristics such as accuracy, precision, selectivity, linearity, and robustness to demonstrate its reliability. The results are compared against predefined acceptance criteria, which are often based on the application's requirements or regulatory standards like those from the International Council for Harmonisation (ICH).
| Identifier | MLC-T-CHM-009491 |
|---|---|
| Field | Chemistry |
| Subject | Analytical Chemistry |
| References | PAC, 2021, 93, 997. 'Metrological and quality concepts in analytical chemistry (IUPAC Recommendations 2021)' on page 1032 (https://doi.org/10.1515/pac-2019-0819) |
| See also | Capability; Interlaboratory comparison; Measurement procedure; Performance characteristic of a measurement procedure; Requirement |
Record as JSON
{
"id": "MLC-T-CHM-009491",
"term": "Procedure validation",
"field": "Chemistry",
"definition": "The process of confirming by examination and objective evidence that a specific analytical procedure is fit for its intended purpose. This involves systematically evaluating performance characteristics such as accuracy, precision, selectivity, linearity, and robustness to demonstrate its reliability. The results are compared against predefined acceptance criteria, which are often based on the application's requirements or regulatory standards like those from the International Council for Harmonisation (ICH).",
"subject": "Analytical Chemistry",
"see_also": [
"capability",
"interlaboratory comparison",
"measurement procedure",
"performance characteristic of a measurement procedure",
"requirement"
],
"references": [
"PAC, 2021, 93, 997. 'Metrological and quality concepts in analytical chemistry (IUPAC Recommendations 2021)' on page 1032 (https://doi.org/10.1515/pac-2019-0819)"
],
"url": "https://mlchart.com/terminology/chemistry/procedure-validation/"
}
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