Method validation is a process that is used to demonstrate the suitability of an analytical method for an intended purpose. Validation procedures have been developed by a variety of industrial committees, regulatory agencies, and standards organizations for purposes of quality control and regulatory compliance.

How do you validate analytical methods?

The analytical method validation is governed by the International Conference on Harmonization (ICH) [1,2]. The key criteria for evaluation of an analytical method are: specificity, accuracy, precision, detection limit, quantitation limit, sensitivity, working range and linearity, robustness and recovery [3,4].

What is the purpose of analytical method validation?

The purpose of analytical method validation is to confirm and document that the method works as intended. Irrespective of any prior validation or qualification work done for prospective methods, any time a method is transferred, installed, or created on a new or existing system, it must be validated.