GLP authorities

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, [e-mail] 
• FOEN: Christoph Moor, [e-mail]
• Swissmedic: Elisabeth Klenke, [e-mail]

For any questions about the coordination and decision authority please contact:

• Notification authority for chemicals: Diana Burkhalter, [e-mail]

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.

Documents

List of the GLP inspectors (PDF, 31 kB, 24.03.2023)

Swiss Compliance Monitoring Programme 2024 (PDF, 441 kB, 04.04.2024)

Links

Useful 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

• Europäische Chemikalienagentur ECHA

European Medicines Agency (EMEA)

• EMEA

U. S. Food and Drug Administration (US-FDA)

• US-FDA
• FDA/ORA Bioresearch Monitoring Information Page

U.S. Environmental Protection Agency (US-EPA)

• US-EPA

Associations of Quality Assurance

• SPAQA-Swiss Professional Association of Quality Assurance
• RQA - British Association of Research quality Assurance
• SQA - The Society of Quality Assurance
• GQMA - Deutsche Gesellschaft für Gute Forschungspraxis
• SOFAQ
  

Legal basis

Ordinance on Good Laboratory Practice (OGLP)

Last modification 07.03.2019