ABSTRACT
PURPOSE OF THE QOS The QOS provides summary information from each section of Module 3 to give the Quality/Chemistry Manufacture and Controls reviewer an overview of Module 3. It should emphasize critical key parameters of the product. Where the development of the product did not follow ICH, relevant regional, or national guidelines or pharmacopoeial requirements, the QOS should explain and justify the approach followed. The objective of providing a well-written QOS is so that it can then be used by the quality reviewer in the regulatory agency to facilitate their review and help them produce their own Assessment Report on the product.
