Nur in der englischen Sprache.
There are three GLP compliance monitoring units and one coordination and decision authority in Switzerland.
For any questions about the GLP compliance monitoring units please contact:
- FOPH: Sabine Frey, sabine.frey@bag.admin.ch
- FOEN: Christoph Moor, christoph.moor@bafu.admin.ch
- Swissmedic: Elisabeth Klenke, Elisabeth.Klenke@swissmedic.ch
For any questions about the coordination and decision authority please contact:
- Notification authority for chemicals: Diana Burkhalter, diana.burkhalter@bag.admin.ch
The GLP compliance monitoring units are competent to carry out inspections and study audits as follows:
| Areas of Activity | Pharmaceuticals | Non-Pharmaceuticals |
| Health | Swissmedic | FOPH |
| Environment | FOEN | |
The three GLP compliance monitoring units act on the same bases and provide uniform execution. All activities are coordinated between the GLP authorities.
More information concerning the organization of each GLP compliance monitoring unit and the notification authority for chemicals is given in the GLP compliance monitoring programme.
Dokumente
Links
Nützliche Links
GLP within Organizations / Authorities
Organisation for Economic Co-operation and Development (OECD)
- OECD Members of the Working Group on Good Laboratory Practice (GLP)
- OECD Series on Principles of Good Laboratory Practice (GLP) and Compliance Monitoring
Europäische Chemikalienagentur
European Medicines Agency (EMEA)
U. S. Food and Drug Administration (US-FDA)
U.S. Environmental Protection Agency (US-EPA)
Associations of Quality Assurance
Rechtsgrundlagen
Letzte Änderung 07.03.2019
