Erweiterung des GMP-Qualitätsmanagementsystems und die zukünftige Entwicklung bei der FDA
Dr. Heinrich Prinz
In 2002 the FDA published a new strategy concerning cGMP regulations and with respect to the quality of drugs and medicines. One important point in this new strategy is the way in which a quality management system is to be implemented. A FDA draft guideline published in September 2004 incorporated the new methodology for the implementation of a quality management system. This guideline describes the way in which the FDA harmonised their own internal regulations with those of international requirements. The result is that the first part of the guideline describes various general aspects pertaining to the quality management system to be implemented. In the second part of the guideline new and special requirements for management are outlined. This is due to the fact that the FDA views the responsibility for the quality management system being with management.
The following article describes firstly the new methodology now drafted by the FDA for an integrated and complete quality management system. The second part of the publication describes ways in which the recommendations of the new guideline may be fulfilled. It will become evident to the reader that the implementation of quality management systems within the pharmaceutical industry will tend more and more towards DIN-ENISO 9001:2000, especially with regard to the American market. Furthermore, with regard to further guidelines, and in particular for combination products, the harmonisation of Drugs and Medical Devices must become more closely coordinated in the near to midterm future. This article, therefore, makes frequent reference to the general area of medical devices.