A review on analytical method validation

Abstract

Method validation is the process used to confirm that the analytical procedure employed for a specific test is suit- able for its intended use and the results obtained can be used to judge the quality, reliability and consistency of analytical results. For method to be validated it require the cooperative efforts of several departments, including analytical development, quality control and regulatory affairs. Analytical method validation is necessary in an ana- lytical laboratory to show its qualification and competency. Method validation is an essential component of the measure that laboratories should employ to ensure that they produce accurate and reliable results hence, ensur- ing business continuity. Method validation should, if possible, have means of involving the customers that will be using the results. The involvement of customers ensures that method performance, as required by customers, is incorporated early before a method is developed. The important steps in the validation are accuracy, Precision, Specificity, Limit of detection, Limit of quantitation, Linearity and range, Ruggedness, Robustness. These studies are useful to confirm the stability indicating analytical method development for various regulatory markets.