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Fresenius Kabi

The global quality management system at Fresenius Kabi is based on the internationally recognized ISO 9001 standard, which takes into account many national and international regulations governing product and services development, manufacturing, and marketing. 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 ISO 13485 quality management standard for medical devices. The global quality management system is certified by TÜV Süd and annually audited on an international basis. Our quality management comprises:

  • Global processes and standards: Fresenius Kabi has implemented a global quality management handbook as well as standard operating procedures, and has defined specific work instructions. Detailed best practice approaches are elaborated in teams worldwide and are laid down in global guiding documents. Those apply to all production plants and sites of Fresenius Kabi.
  • Early warning system: Our early warning system allows us to evaluate risk situations and identify the need for corrective and preventive actions at an early stage. The system comprises standardized structures for regular reporting as well as ad-hoc reporting. Key performance indicators, e. g., complaint rates, are evaluated following any action taken.
  • Integrated global crisis management: Safety officers respond immediately when we are informed of a problem with quality or patient safety. They manage product recalls centrally.

At Fresenius Kabi, inspections by regulatory authorities and audits by independent organizations and customers are performed along the entire value chain. Whenever these inspections reveal any weaknesses or deficiencies, Fresenius Kabi promptly takes corrective and preventive measures.

However, our quality management system does not just extend to internal processes. It also covers the application of our products and services by customers. In order to be able to receive information about their problems in a timely manner and deal with them appropriately, Fresenius Kabi has set up a global monitoring and reporting system (vigilance system). The responsible regulatory authorities monitor this system and keep an increasingly close eye on it in the interests of patient safety. The system has passed a number of inspections by various international health authorities.

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