ABSTRACT
This chapter discusses the possibilities of reducing costs in the stability programs and the possibilities that such reduction will be accepted by the licensing authorities and focuses on the finished dosage forms. Among the resources required to prepare an application for a Marketing Authorisation, those needed to perform stability testing of the drug substance and the drug product exhibit a considerable part of the costs for the quality part of the dossier. Therefore, the Committee for Proprietary Medicinal Products decided early on that a European extension guideline should be elaborated to describe in some more detail under which circumstances it is acceptable to apply bracketing or matrixing when setting up a stability protocol. In general, “excellent” and “moderate” stability means good shelf life, with little or no change in product test parameters. Stability testing forms an essential part of the documentation for several reasons.
