Organisation
The table lists the institutions, along with their tasks, involved in Germany in Good Laboratory Practice.
|
Institutions
|
Tasks
|
The tasks correspond to the following provisions in the
Chemicals Act (ChemG)
|
|---|---|---|
| Federal Government (Federal Ministry for the Environment, Nature Conservation and Nuclear Safety) | Overall in charge of GLP legislation | §§ 19a-d ChemG |
| GLP Federal Bureau | Co-ordination and harmonisation of GLP issues and monitoring of specific GLP laboratories inside and outside Germany | §§ 19b, d ChemG |
| Regulatory authorities | Verification of the formalities according to GLP when assessing safety studies | § 19a ChemG |
| Monitoring authorities | Inspection of test facilities and examination of individual tests for compliance with GLP Principles | § 19b ChemG |
| Federal/Länder Task Force GLP Working Group (BLAC-AK-GLP) | Further development and harmonisation of GLP monitoring in Germany | § 20b ChemG |
| Test facility | Conduct of studies in accordance with GLP Principles | § 19a ChemG Annex 1 to ChemG (GLP Principles) |
