Ordinance on Good Laboratory Practice (OGLP)
English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force.
Art. 1 Objective and purpose
1 This Ordinance lays down the Principles of Good Laboratory Practice (GLP) as the quality standard for studies, and regulates compliance monitoring. 2 The Ordinance aims to: a. ensure that test data are reproducible; b. promote international acceptance of tests conducted in Switzerland in order to avoid duplicate testing.
Art. 2 Scope
The Ordinance applies to non-clinical studies of substances, preparations and articles (test items) that: a. serve to obtain data on the properties of a test item and its safety with respect to human health and the environment; and b. provide data to be submitted to the authorities in view of a registering or licensing procedure.
Art. 3 Definitions
1 In this Ordinance: a. Good Laboratory Practice (GLP) means a quality system concerned with the organisational process and the conditions under which studies are planned, performed, monitored, recorded, archived and reported; b. areas of expertise means studies conducted in the following categories: 1. physical-chemical testing, 2. toxicity studies, 3. mutagenicity studies, 4. environmental toxicity studies on aquatic and terrestrial organisms, 5. studies on behaviour in water, soil and air; bioaccumulation 6. residue studies, 7. studies on effects on mesocosms and natural ecosystems, 8. analytical and clinical chemistry testing, 9. other studies, specify; c. study audit means an audit of a study to verify that its data, records, reports and other elements comply with GLP Principles; d. test facility means the persons, premises and operational unit(s) that are necessary for conducting studies; for multi-site studies conducted at more than one site, the test facility comprises the site
Para. 1 let. b — Amended by Annex No 2 of the O of 7 Nov. 2012, in force since 1 Dec. 2012 (AS 2012 6103).