Chapter 3 Overview of world-wide regulations

Abstract

Publisher Summary Analytical validation is a very important feature of any package of information submitted to international regulatory agencies in support of new product marketing or clinical-trial applications. The extent of detailed guidelines for requirements provided by different agencies varies widely. This chapter reviews the guidelines provided by the three main geographical regions—the United States, Europe, and Japan—for the validation of methods used in pharmaceutical analysis and bioanalysis. Regulations from some of the smaller regulatory agencies, such as Canada and Australia, are also discussed because these agencies provide some of the clearest directions on method validation. The recent International Conference on Harmonization (ICH) initiative is described in the chapter. This initiative attempts to harmonize several regulatory guidelines in the area of pharmaceutical drug substance and finished-product testing, including one for analytical method validation. Chromatographic procedures are frequently used in pharmaceutical analysis, and they have been the subject of the most extensive work in method validation.