Pre-Validation Requirements: Specificity: Linearity and Range: Accuracy and Precision: Robustness: Limit of Detection & Quantitation: System Suitability: Observations and Deviations: Analytical test method validation is a cornerstone of scientific accuracy and precision. Read also:
Prerequisites is usually a checklist which is sent to the Receiving Laboratory which in most of the cases is the Quality control laboratory of the manufacturing. This checklist is prepared by the Department or the team which is involved in the method validation/verification/transfer activity and contains all the things which are required and needed…
Linearity earity is one of the key parameters assessed during method validation. It refers to the ability of an analytical method to produce results that are directly proportional to the concentration or amount of the analyte within a specific range When a method is linear, it means that the response of the measurement instrument…
Precision is one of the most important quality characteristics of an analytical method. It is a measure of how reproducible the results of the method are. Precision is important in method validation because it ensures that the method is producing consistent results. This is essential for ensuring the accuracy and reliability of the analytical…
Accuracy determines whether the product can be extracted using the solvent used in the test method. Assay: In drug manufacturing, it is crucial to accurately determine the concentration of the active pharmaceutical ingredient in the finished product. For example, if a tablet is claimed to contain 100 mg of a specific drug, the validated…
Filtration can have significant effects on the results of analytical method validation, particularly in sample preparation and analysis processes. Filtration plays a role in method validation in several ways: Filtration study, the sample should be filtered through the proposed filter and the results should be compared with the unfiltered (centrifuged) sample. Acceptance…
