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4 paź 2018 · The ICH, FDA, and USP define the test procedure parameters to validate as encompassing accuracy, precision (repeatability, intermediate precision, and reproducibility), specificity, limit of detection, limit of quantitation, linearity, robustness, and system suitability testing.
19 lut 2014 · An analytical procedure is developed to test a defined characteristic of the drug substance or 99 drug product against established acceptance criteria for that characteristic.
Verification that a laboratory can adequately operate a standard method requires that the laboratory provide objective evidence the performance parameters specified in the test method have been met with the matrices to which the method is being applied.
Test method validation is the documented process of ensuring a test method is suitable for its intended use. It involves establishing the performance characteristics and limitations of a method and the identification of influences which may change those characteristics.
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.
17 maj 2019 · The Metrology Laboratory follows this procedure to ensure that all laboratory methods selected, modified, or developed for tests and calibrations are appropriate for the intended use, properly documented, validated, accepted by laboratory management, and agreed upon by the client.
19 sie 2015 · The aim of a method validation is to present objective evidence that a method fulfills the requirements for its intended use. Although much has been published on which parameters to investigate in a method validation, less is available on a detailed level on how to perform the corresponding experiments.
