Good Laboratory Practice (GLP) according to 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. No special form ist available for the application.
For each test facility, the application must include the following information:
- name and address of the test facility;
- site plans documenting the use of the individual premises;
- organisational charts documenting the name and position of the test facility management, the personnel in charge of quality assurance and the study directors;
- name and address of a contact person;
- standard operating procedures for quality assurance;
- a list of all standard operating procedures;
- the relevant study categories;
- a list of all studies planned over the next six months with the relevant schedules;
- a list of all studies conducted over the last six months, or still being carried out, in the relevant study categories.
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 authority (GLP compliance monitoring unit) 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.
Last modification 26.09.2016