GLP Federal Bureau

"Good Laboratory Practice (GLP) is a quality system concerned with the organisational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported."

This is the definition of "Good Laboratory Practice" in the "OECD Principles of Good Laboratory Practice" which were then transposed into EC Directives and, after that, into German law as Annex 1 of the German Chemicals Act. In paragraphs 19a to 19d the scope and type of monitoring of GLP are laid down by law.

As a consequence of its global implementation and largely mutual recognition of test data, GLP has contributed more than any other quality system to health, environmental and animal protection. Multinational companies can, for instance, cut back their animal experiments by around 70% thanks to the mutual recognition of GLP implementation.

The GLP Federal Bureau at the BfRshort forGerman Federal Institute for Risk Assessment is responsible, on the basis of the German "General Administrative Provision on the Procedure of National Monitoring to ensure Good Laboratory Practice (ChemVwV-GLP)", for the coordination and harmonization GLP-relevant tasks in the national and international area as well as the monitoring of certain GLP test facilities in Germany and abroad, stipulated in §§ 19a-d Chemicals Act (ChemG). Pursuant to the Chemicals Act they encompass the co-ordination and harmonisation of GLP issues in the national and international areas and in monitoring specific GLP test facilities both inside and outside Germany.

Dr Christian Strüh
Phone: +49 30-18412-22106

Gabriele Bründl
Phone: +49-30-18412-22107

Anne Grünberg
Phone: +49-30-18412-22105

Dr Sebastian Schmidtsdorff
Phone: +49 30-18412-22109

Fax: +49 30-18412-99099

E-mail: glp-bundesstelle@bfr.bund.de


Postal address:
German Federal Institute for Risk Assessment
GLP Federal Bureau
Max-Dohrn-Str. 8-10
D - 10589 Berlin

On the level of the federal states (the Länder) authorities are responsible for monitoring compliance with the Principles of GLP and the granting of a GLP Certificate according to § 19b para 1 Chemicals Act.