Method validation involves conducting a variety of experiments that focus on performance elements of the method to be validated. For instance, with chromatographic assay validation, it is essential to establish the method specificity, accuracy, precision, and linearity over a STATED concentration range, as well as the stability properties of the solutions, CONTROLS, and sample materials. Additional validation experiments may serve to VERIFY robustness, which is the capacity of the method to perform as intended despite minor variations in sample handling or analytical conditions.

Assay validation parameters vary from method to method, depending on the purpose of the assay, the compounds of interest, and other critical components of the analysis.

Further experiments must be done to re-validate a method that has undergone changes, e.g., to equipment, materials, analytical scope, or the location where it is being USED.

Method validation involves conducting a variety of experiments that focus on performance elements of the method to be validated. For instance, with chromatographic assay validation, it is essential to establish the method specificity, accuracy, precision, and linearity over a stated concentration range, as well as the stability properties of the solutions, controls, and sample materials. Additional validation experiments may serve to verify robustness, which is the capacity of the method to perform as intended despite minor variations in sample handling or analytical conditions.

Assay validation parameters vary from method to method, depending on the purpose of the assay, the compounds of interest, and other critical components of the analysis.

Further experiments must be done to re-validate a method that has undergone changes, e.g., to equipment, materials, analytical scope, or the location where it is being used.