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The objective of validation of an analytical procedure is to demonstrate that it is suitable for its intended purpose. A tabular summation of the characteristics applicable to identification, control of impurities and assay procedures is included.
The multivariate calibration model relate the input data to a value for 122 the property of interest (i.e., the model output). 123 Successful validation of a multivariate procedure should consider calibration, internal testing 124 and validation. 125 Typically, calibration and validation are performed in two phases.
Validation records of established performance specifications (accuracy, precision, analytical sensitivity, analytical specificity, interferences, reference interval(s), and reportable range) of any test that has been modified.
14 cze 2024 · It provides guidance and recommendations on how to derive and evaluate the various validation tests for each analytical procedure and serves as a collection of terms, and their definitions.
Verify that the method provides acceptable precision, accuracy, and linearity when applied to samples at the extreme as well as within the range. Recommended minimum Ranges:
Accuracy Yes If the method is a limit test or if the concentration range for which the method is validated is narrow (<1 order of magnitude), analyze one reference material/standard/spike at one concentration. Otherwise, demonstrate accuracy at each concentration level, low middle and high by analyzing one reference material/standard/spike at ...
The multivariate calibration model relates the input data to a value for the property of interest (i.e., the model output). Successful validation of a multivariate procedure should consider calibration, internal testing and validation. Typically, development and validation are performed in two phases.
