Organization of GLP monitoring in Germany
The tabular overview shows the institutions involved in Good Laboratory Practice monitoring in Germany and their respective tasks.
Institutions
| Institutions | Tasks | Tasks Correspond to the Following Provisions in the German Chemicals Act (ChemG) |
|---|---|---|
| Federal Government (Federal Ministry for the Environment, Climate Action, Nature Conservation and Nuclear Safety) | Highest GLP Authority | §§ 19a-d ChemG |
| GLP Federal Bureau | Coordination and harmonization of GLP-related matters and supervision of certain GLP laboratories in Germany and abroad | §§ 19a-d ChemG |
| Receiving Authorities | Review of GLP formalities in the evaluation of substance studies | § 19a ChemG |
| State Authorities | Inspection of test facilities and review of individual studies for compliance with GLP principles | § 19b ChemG |
| Federal-State working party -Chemicals Safety Committee “GLP and other quality assurance systems” (BLAC-AS-GLP) | Further development and harmonization of GLP monitoring in Germany | § 20b ChemG |
| Test Facility | Conducting studies in accordance with GLP principles | § 19a ChemG Annex 1 to ChemG (GLP-principles) |