The Implementation of European Community Directives Concerning GMP

Abstract

European Directives will place obligations on member states to introduce legislation requiring manufacturers and importers to be authorized and to comply with GMP by January 1, 1992. The Principles of Good Manufacturing Practice (GMP) will be stated in a Directive. Detailed interpretative Guidelines have already been published and will be supplemented. While national legislation need not be identical throughout the Community, work is underway to harmonize inspection standards and practices, in which the experience of the Pharmaceutical Inspection Convention may be useful.