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Unit GLP Federal Bureau and Quality Management

As the GLP Federal Bureau, the Unit is responsible for the coordination and harmonisation of issues relating to "Good Laboratory Practice" on national and international levels as well as the monitoring of certain GLP test facilities in Germany and abroad. The Unit also handles general questions on quality management, in particular regarding interfaces and demarcation issues between Good Laboratory Practice and other QM systems (e.g. GMP, GCP, accreditation and certification). Working in close cooperation with the quality management coordination experts at the BfR, the GLP Federal Bureau shares the experience it has gained through its national and international activities to promote the implementation and maintenance of quality management concepts at the BfR. All work areas at the BfR have been certified in accordance with DIN EN ISO 9001 since 2010. The BfR laboratories have been accredited in line with DIN EN ISO 17025 since 2002. The Unit GLP Federal Bureau and Quality Management is also responsible for the ongoing development, maintenance and administration of the "Laboratory Information Management System" (LIMS) at the BfR.

The legal remit of the GLP Federal Bureau at the BfR is outlined in the “General Administrative Provision GLP " (ChemVwV-GLP) and Sections 19b Para. 2 No. 3 and 19d Para. 1 of the German Chemicals Act. 

You can find more information, such as the list of test facilities in the German GLP monitoring programme (496.2 KB), the GLP monitoring authorities in the regional laender (314.6 KB) and GLP publications under "Good Laboratory Practice (GLP)".

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