"The purpose of validating an analytical method is to demonstrate that it is fit for the purpose for which it is intended"
Une validation des méthodes est l’ensemble des opérations nécessaires pour prouver que le protocole est suffisamment exact et fiable pour avoir confiance dans les résultats fournis et ceci pour un usage déterminé.

Validation criteria

Specificity

"Ability of the method to allow unequivocal evaluation of the analyte in the presence of components that are likely to be present"

Linearity

"Ability within a given range to obtain assay results directly proportional to the concentration or amount of analyte in the sample"

Accuracy

Tightness of agreement between the mean value obtained from large series of tests and an accepted reference value

Loyalty

• Accuracy: "Closeness of agreement between a series of measurements obtained under prescribed conditions from multiple test samples from the same homogeneous sample".
• Repeatability: "Repeatability expresses the fidelity evaluated under identical operating conditions and in a short time interval".
• Intermediate precision: "Intermediate precision expresses the intra-laboratory variability: different days, different analysts, different equipment, etc."
• Reproducibility: "Reproducibility expresses the inter-laboratory variability (collaborative studies) usually applied to the standardization of the methodology"
• Range: "The range between the highest and lowest concentration (quantity) of the sample in which the analytical method has been shown to have satisfactory precision, accuracy, and linearity."
• Detection limit
  "The detection limit of an analytical method is the smallest amount of analyte that can be detected but not necessarily quantified as an exact value."
• Limit of quantification
  "Lowest amount of analyte in a sample that can be determined quantitatively with appropriate precision and accuracy."
• Robustness
  "Ability of the protocol to remain unaffected by small but deliberately introduced variations in method parameters; provides an indication of its reliability under normal conditions of use"
• Stability of solutions
• Verified on standard solutions and samples