Privatsphäre-Einstellungen

NOVARTIS Pharma Ltd. organised in Switzerland a meeting for the German-speaking industry on the subject of process simulation/media fill. The aim of this meeting was to establish a consolidated basis as to the performance, recon ciliation and requirements of process simulations (media fills). The result of this meeting shall serve as a basis for discussion, especially in the event of regulatory inspections where -due to the lack of uniform and clear requirements in the form of guidelines -the pharmaceutical manufacturers often make concessions to inspectors who take different views. In the course of time these concessions become „state-of-the-art“ arguments, though often absolutely unfounded. The agreements resulting from this meeting are explained in detail in the following paper.