Accuracy is one of several data elements required for assay validation. In a regulated pharmaceutical laboratory, determining accuracy can take on many diff e rent forms. This month’s installment of “Validation Viewpoint” focuses on ways to measure and documentn past “Validation Viewpoint” columns and other publications, we have discussed different methods of quantitation as a distinct and decided part of method validation (1–4). And while many factors are taken into account when validating a method, the determination of the method’s accuracy is an integral part of validating any quantitative method. Accuracy is defined as the closeness of the test results obtained by the method of i n t e rest to the true value, demonstrated a c ross the range of analyte levels expected to be found in samples during routine analyses (5). The determination of accuracy varies according to the method’s intended purpose, and whether the sample is a drug substance, the final drug product, or related impurities. In general, accuracy is determined for drug substances by comparison with standard reference materials; for drug products by the analysis of synthetic mixt ures spiked with known quantities of components; and for impurities, it is determined by the analysis of samples (either drug substance or drug product) spiked with known amounts of impurities. For drug substances and drug products, accuracy also can be inferred in some instances once precision, linearity, and specificity h a ve been established. accuracy for typical pharmaceutical formulations, including synthetic drugs and bioanalytical samples. For full article Click Here

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