Fresenius Kabi

Quality management at Fresenius Kabi is subject to a great many national and international regulations such as Good Clinical Practice (GCP), Current Good Manufacturing Practice (cGMP), Good Distribution Practice (GDP) for drugs and ISO Standard 13485:2003 for medical products. All of these requirements have been integrated into a quality management system conforming to ISO Standard 9001:2008 to ensure that the applicable regulations are reliably complied with.

With the exception of the companies acquired in 2008, Fresenius Kabi has included most of the global production plants and the local sales organizations in the external certification process. Quality management at our production sites, in the sales organizations, and at a cross-functional level is reviewed regularly by both national and international regulatory authorities and by customers.

The matrix certification to ISO 9001 was continued as planned in 2009. The focus of the new certification was on the Fresenius Kabi compounding centers. The certification process now covers the entire value chain: from the production of the active substances, the manufacturing of the finished drugs, and the patient-specific compounding through to distribution.

The integration of the quality management systems of Fresenius Kabi Oncology (formerly Dabur Pharma) and APP Pharmaceuticals, started in 2008, was continued in 2009. Fresenius Kabi is concentrating on “best practice” solutions perfected to the Group-wide standard in the sense of a continuous improvement of our quality management system. The harmonized standards are being developed at regular meetings of international experts at Fresenius Kabi.

Another special focus is careful and proper handling of hazardous substances. Fresenius Kabi Oncology is a leading supplier of generic drugs and active substances for cancer treatment. Active substances for cancer treatment need to be handled with extreme care, so special attention is paid in our quality management system to the safety of employees who come into contact with this group of products.

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