Good Laboratory Practice (GLP)

In Switzerland, the Good Laboratory Practice (GLP) is based on the OECD principles of GLP issued on 26th November 1997. The ordinance on Good Laboratory Practice (OGLP, SR 813.112.1) was issued on 18th May 2005 and enacted on 1st August 2005.

GLP is defined as follows (see art. 3 par. 1 lt. A OGLP):

A quality system concerned with the organisational process and the conditions under which studies are planned, performed, monitored, recorded, archived and reported.

Establishments that wish to have their test facilities listed in the Register pursuant to art. 14 OGLP must apply according to art. 5 OGLP to the notification authority for chemicals. The notification authority for chemicals coordinates the carrying out of inspections and of study audits with the Federal Office for the Environment (FOEN), the Federal Office of Public Health (FOPH) and the Swiss Agency for Therapeutic Products (Swissmedic).

The following authorities are competent to carry out inspections and study audits:

the FOPH and Swissmedic for studies of toxicological properties;
the FOEN for studies of ecotoxological properties or of environmental behaviour of the test items;
the FOPH, the FOEN or Swissmedic after mutual agreement for studies of all other properties.

The GLP authority carries out inspections and study audits according to the guidelines in Sections A and B of Appendix I of European Directive 2004/9/EC of the Parliament and of the Council of 11 February 2004. The GLP Monitoring Authorities of the FOPH, the FOEN and Swissmedic act according to the same GLP compliance monitoring programme.