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Statutory tasks of the GLP Federal Bureau

The GLP Federal Bureau has the following statutory tasks in respect of the organisation of GLP monitoring in Germany:

• Carrying out of GLP inspections in the test facilities of federal authorities on behalf of their supervisory body (as a rule the competent Federal Ministry):
• On request issuing of a GLP certificate for submission to the German regulatory authority for a test facility in a country which is not a Member State of the EU and with which there is no comprehensive bilateral agreement with the EU or Germany on the mutual recognition of national GLP programmes, if the GLP Federal Bureau is satisfied that the test facility performs studies in compliance with the Principles of GLP;
• Compiling, maintaining, updating and publication of a list of test facilities in Germany and in other States inspected by German inspectors and inspection results;
• Collection and evaluation of the inspection reports of the inspection teams of the Länder and preparation of statistics;
• Elaboration of an annual report for the EU and OECD Member States about the German GLP monitoring activities;
• Expert advice to the Federal Government and the Länder in the field of GLP about the following tasks:
  • National co-ordination of GLP (amongst other things Guide on the Harmonisation of the GLP Monitoring Procedure, only available in German language);
  • Interpretation of the GLP requirements and monitoring compliance with said requirements;
  • Participation in the revision of laws including official substantiation;
  • Participation in the Federal/Länder Task Force "Chemical Safety" and its working groups (BLAC-GLP);
  • Participation in the preparation of national consensus documents (Archiving, Data processing);
  • Participation in the German Accreditation Council (DAR) and its working groups;
  • Responding to individual questions on the interpretation of GLP Principles;
  • Advising the regulatory authorities and providing support for the organisation of GLP study audits in Germany and abroad;
  • Updating the Handbook on monitoring compliance with GLP Principles for inspectors
  • Staging nationwide training courses for inspectors
• Expert advice to the Federal Government and participation in international procedures and in international expert bodies within the framework of GLP:
  • on the EU level (GLP Working Group, Mutual Joint Visits, Mutual Recognition)
  • on the OECD level (Working Group on GLP, revision of GLP Principles, Mutual Joint Visits, Consensus Documents, Workshops)
  • involvement in the preparation and, where appropriate, expert translation of OECD and EU documents

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