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Fresenius Kabi

Quality management at Fresenius Kabi is based on the internationally recognized quality management standard ISO 9001 and a great many other national and international regulations that govern product manufacturing at Fresenius Kabi. These include, for example, Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), the Code of Federal Regulations (CFR) of the U.S. Food and Drug Administration (FDA) as well as the quality management standard ISO 13485 for medical devices. All regulations were implemented in our company-wide quality management standards. In 2011, we reviewed the quality management system’s compliance with the relevant requirements, which was successfully validated. The entire value chain at Fresenius Kabi is additionally covered by inspections by regulatory authorities and audits by independent organizations and customers.

In 2011, we optimized our organizational structure and regrouped the areas of responsibility at Fresenius Kabi in a better way. Our Code of Conduct applies globally and now harmonizes the existing corporate guidelines and standards. The quality management reflects the new structure.

We are continuously adapting our quality management system to changing legal requirements. In 2011, for example, new requirements regarding the EU GMP Directive became effective. In addition, a EU Directive about counterfeit medical products was published and comprehensive EU regulations were passed to control the effects of the nuclear power plant accident in Japan. These regulations cover the use and control of origin of raw materials used for manufacturing pharmaceuticals.

The matrix certification as per ISO 9001 was continued as planned in 2011. Over 90% of all manufacturing and sales locations of Fresenius Kabi are already included in the certification. The remaining organizations will be successively integrated.

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