Author(s): Ravindra B. Nehete, Pushpendra Sharma
Analytical method validation is demonstration for analytical procedure that it is suitable for intended purpose, method validation is must for the all analytical methods for which we requires precise and accurate results. Every analytical method should either verified or revalidated to check its appropriate use for its intended purpose. Analytical method validation initiated with development of Analytical method and through process of drug commercialization and finally culminated in market. This study provides the thorough review of method development, optimization and validation of the analytical method for the drug substance as well as drug product from initial development to commercialization of the drug product. This process includes the intermediate stages including in-process analysis and stability study for better quality control of the drug product. Analytical method is documentation process proving that equipment, system, materials, procedure, activities and process are performing as per expectation and provides the specific, linear, precise, accurate, robust, etc. results. Analytical method should provide reproducible results even when analysis performed in same or different laboratories by suing different make chemicals, equipments and by different analyst in different environmental conditions. In this review article, we discussed about analytical method validation, importance of planning and its consequences.