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Unit GLP Federal Bureau and Quality Management
All internal and external tasks of BfR concerning quality management/quality assurance are bundled within this Unit. The national and international experience garnered by the GLP Federal Bureau in the globally recognised quality assurance system “Good Laboratory Practice” is the ideal complement to the internal activities on the implementation and maintenance of the quality management systems within BfR based on international standards.
The GLP Federal Bureau within BfR is responsible for the tasks set out in §§ 19b para 2 no. 3 and 19d para 1 Chemicals Act on the basis of the “General Administrative Provision GLP (ChemVwV-GLP)”. This involves the co-ordination and harmonisation of GLP issues on the national and international levels and the monitoring of certain GLP test bodies at home and abroad.
The quality management tasks result from the internationally binding ISO standards and encompass firstly the co-ordination of all activities within the framework of the accreditation of all BfR laboratory areas pursuant to EC Directive 93/99 and Regulation (EC) No. 882/2004 on the basis of DIN EN ISO/IEC 17025 and secondly co-ordination activities within the framework of the implementation of DIN EN ISO 9001:2000 concerning the preparation of the Institute for certification.