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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 development, manufacturing, and marketing 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 ISO 13485 quality management standard for medical devices. The global quality management system is certified and annually audited by TÜV Süd. The implementation of the global quality management system and the certification is mandatory for all organizations worldwide. Our quality management comprises:

  • Global processes and standards: Fresenius Kabi has defined global quality management processes and standards in a quality management handbook and standard operating procedures. 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. Regular training workshops and quality meetings aim to ensure the awareness of our employees on quality control.
    Furthermore, Fresenius Kabi has established electronic workflows and databases to control critical global processes, e. g. complaint management, processing and reporting of adverse drug reactions, as well as corrective and preventive actions.
  • Early warning system: an early warning system evaluates risk situations and identifies the need for corrective and preventive actions at an early stage. The system comprises standardized reporting structures for regular as well as ad hoc reporting. Key performance indicators, e. g. complaint rates, are evaluated following any action taken. Internal audits cover all organizations and their compliance with our quality management. Results from inspections by authorities are assessed internally on a global basis.
  • Integrated global crisis management: To react rapidly and appropriately to any potential issue, we have installed a centralized global recall management monitored by a corporate safety officer.

Inspections by regulatory authorities and audits by independent organizations and customers are performed along the entire value chain at Fresenius Kabi. Whenever these inspections reveal any weaknesses or deficiencies, Fresenius Kabi promptly takes steps to deal with them.

However, our quality management 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) comprising a network of safety & complaints officers in the various countries. This system complements our early warning system. These employees use workflow systems to obtain structured information about products, such as complaints, side effects, or product risks. Reports are passed onto product experts as they are received and investigated at a global level. Whenever necessary, the safety & complaints officers take whatever steps are required, e. g. recalling products. This ensures that we can evaluate the safety profile of any of our products at a global level at any time. The responsible regulatory authorities monitor the vigilance systems and keep an increasingly close eye on them in the interests of patient safety. The Fresenius Kabi system has already passed a number of inspections by various international health authorities.

The matrix certification as per ISO 9001 was continued as planned in 2012. 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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