Privatsphäre-Einstellungen

Up to the passing of EU Directive 2004/27 in March 2004 there was no legal obligation to comply with the appropriate GMPs in the manufacture of active ingredients used in medicinal products either made or sold in the European Union. This Directive changed the situation and requires that all medicinal products industrially manufactured either in, or exported to, the European Union after 30^th October 2005 only contain active substances (APIs) which have been made under EU-GMPs for Active Substances, i.e following ICH Q7a GMPs for APIs. It is however the responsibility of the medicinal product manufacturer to comply with the Directive and, although not specifically stated in the Directive, it is the Qualified Person at either the me-dicinal product manufacturer or importer who must know about the GMP status of the API manufacturer when releasing the medicinal product. Several inspection alternatives may be employed to check that the APIs used were themselves manufactured following ICH Q7a GMPs for APIs. This responsibility of the QP must also include knowledge about the GMP status of any brokers or agents, either within or outside the EU who may have handled the API and whether these too comply with ICH Q7a, as these companies are also covered by the EU Directive 2004/27.