Validation of Analytical Procedures: Methodology

Abstract

This note for guidance concerns test procedures used in documentation submitted in accordance with Part 2, sections A-F of the Annex to Directive 75/318/EEC as amended, with a view to the granting of a marketing authorisation for a medicinal product. This guideline is complementary to, and should be read in conjunction with, the guideline on Validation of Analytical procedures: Definitions and Terminology.