Résumé
French, European and American good manufacturing practices require analytical techniques to be validated before they are used in quality control laboratories. The experimental and statistical methodology used for validation studies is outlined in international standards, guidelines, and pharmacopoeia texts. In this work, all the requirements and recommendations relating to validation are addressed, as well as those relating to other practices that may involve validated analytical methods, such as transfer and verification. To help clarify the strategy for implementing methods, a case study is presented including two examples of analytical procedures which use two different analytical techniques (reverse-phase liquid chromatography and capillary zone electrophoresis). These are sourced from the European pharmacopoeia monograph for somatropin, revised in January 2023.