Validation of an Analytical Procedure

of an analytical procedure is performed in order to demonstrate that the procedure is suitable for its intended use. is performed in order to show that the result(s) generated by a particular analytical procedure are reliable and accurate. The principles and practices of validation of analytical procedures are covered by the International Conference on Harmonisation (ICH) and are published as guideline Q2 (R1), Validation of Analytical Procedures: Text and Methodology. A full discussion of the terms and methodology applicable to validation of analytical procedures is provided in these documents.