Comparison of various international guidelines for analytical method validation

Analytical method validation is the systematic process of establishing that an analytical method is acceptable for its intended purpose. In general the developer or user of the method generates evidence on specificity, linearity range, accuracy, precision, detection limit, quantitation limit, ruggedness and robustness of the method for regulatory submissions or in-house application. The iterative process of method development and validation has a direct impact on the quality of the above data. Such validated analytical methods for qualitative or quantitative testing of drug molecules assume greater importance when they are employed to generate quality and safety compliance data during development and post-approval of drug products. The present paper aims to discuss salient points of the analytical method development and validation cycle. It also attempts to compare and summarize guidelines issued by different agencies for validation of analytical methods used for analysis of drug substances in the pure form and in pharmaceutical formulations.