SCIENTIFIC INSTITUTE OF PUBLIC HEALTH General Direction: GLP-Monitorate Rue J.Wytsmanstraat 14, 1050 Brussel-Bruxelles Belgie-Belgique contact: G.Jacobs or M. Baeten T: +32 (0)2 642 5230 or 5346 M: +32 (0) 473 870 448 or (0)478 689 594 guido.jacobs@wiv-isp.be

WELCOME TO THE WEBPAGE OF THE

BELGIAN GLP MONITORING AUTHORITY

The application of Good Laboratory Practice in safety testing of chemicals is required under several directives of the European Union (EU) and is laid down in different regulations in Belgium. The text and the legal form of this requirement is different in the respective decrees, but finally they have all the same effect: the OECD Principles of Good Laboratory Practice have to be applied where results of safety tests on chemicals are submitted to Regulatory Authorities in Belgium for safety assessment purposes. (See "Scope of Good Laboratory Practices" for more information.)

The Scientific Institute of Public Health (IPH) has been designated by the Royal Decree of 27 October 1988, (modified by the Royal Decree of 6 March 2002) as the Belgian GLP Monitoring Authority for GLP compliance assessment. It is a non-profit and fully independent organization. The general director of the IPH is the responsible person of the GLP Compliance Monitoring Authority and is especially charged with the approval of the "Statement of GLP Compliance" of the test facilities.

The IPH is a scientific institute in which the GLP Monitorate is only a small section. The GLP Monitoring Authority consists of the General Director of the IPH, the GLP coordinator and different GLP inspectors.

The GLP Compliance Monitoring is intended to ascertain whether test facilities have implemented GLP principles for the conduct of studies and are capable of assuring that the resulting data are of adequate quality. Inspections may be conducted at any test facility generating health and environmental safety data for regulatory purposes. It includes audits of data of physical, chemical, toxicological and/or ecotoxicological testing of chemicals, such as industrial chemicals, pharmaceuticals, veterinary drugs, phytopharmaceuticals, food and feed additives and cosmetics. Field studies are also covered by Good Laboratory Practice and inspected by the GLP Monitoring Authority. Test Facilities for which a Regulatory Authority asks a request for GLP compliance are also listed on the master schedule of the GLP Compliance Program.

The test facilities embodied in the master schedule of the GLP Compliance Program are in principle monitored on a two to three year cycle. The GLP Compliance Program includes Pre-inspections, Test Facility Inspections, Study Audits, follow-up inspections, and Re-inspections. Pre-inspections are carried out if the test facility has to be inspected for the first time. During the Test Facility Inspection not only the organization of the test facility but also on-going and completed studies are verified. Re-inspections are carried out if deviations have been found during the routine inspection for which corrective actions have to be taken which have to be verified. A test facility that is new in the programme will receive a follow-up inspection within 18 months after the first inspection. In the "Master Schedule of Test Facilities with a GLP Compliance Statement", you will find all the Belgian GLP Test Facilities with their addresses, scope, area of expertise and the date of their last compliance statement.

Test facilities who wants to introduce a request for the verification of their compliance with the GLP-principles should address their request to the General Director of the Institute. (Contact the GLP Coordinator for more information.)

Detailed information on the Belgian GLP Compliance Program and the conditions under which test facility inspections and study audits are performed can be found in the GLP compliance Programme Manual.