Analytical Method Validation: ICH and USP Perspectives

The development of analytical methods facilitates comprehension of the crucial process factors and reduces their impact on precision and accuracy. A confirmed systematic technique guarantees accurate, consistent, and dependable data. The metrics shown here are in accordance with ICH criteria and include linearity, range, robustness, accuracy, precision, specificity, and limit of detection, as well as the limit of quantitation. The selective method will produce repeatable, dependable, and consistent results sufficient for the intended purpose, thanks to method validation. As a result, it's essential to specify exactly what the technique is to be employed for as well as under what circumstances. Therefore, one of the most important steps a laboratory should take to develop trustworthy analytical methods is method validation. Keywords: ICH recommendations, validation, accuracy, specificity, and precision.