How to use this FAQ
This FAQ has no legislative power. It is only a tool to indicate how Monitoring Authorities are interpreting the GLP principles. Please also consult the Frequently Asked Questions on the website of the OECD and the website of the EU. Don’t hesitate to contact us if questions still remain.
How can I apply for a GLP certificate?
For all test facilities established in OECD countries, you should contact the national GLP Monitoring Authority responsible for the scope of your studies.
For test facilities established in a non-OECD country you can contact us by phone or via e-mail for more country specific information.
For test facilities established in Belgium you should address a letter to:
General Director of Sciensano,
J. Wytsmanstraat 14,
What is the fee for a GLP inspection?
The price of a GLP inspection is fixed in the Royal Decree of March 6, 2002 (B.S. of 12.03.2002). This means about € 125 per hour (preparation, travelling, inspection, audit, draft report, verification of corrective actions included) per inspector.
- When inspectors need to travel more than 100 kilometres or traffic problems are foreseen, extra costs for lodgements can be asked.
- For inspections abroad of Europe, € 2000 is asked a day/per inspector. The fees for Visa and vaccinations should be refunded. Transport (in business class) and lodgement should be arranged by the test facility;
- To open a new file for new facilities entering the program, an administrative cost will be charged to cover the work for a pre-inspection. For domestic lab, € 500 (in situ inspection); for non-domestic facilities, € 1000 (inspection of documentation).
Can a phase of a GLP study be delegated to a non-GLP lab?
It is not foreseen in the principles that phases of a GLP study are delegated to a non-GLP lab or excluded from the GLP statement. Only under certain, very well defined circumstances (for example if technical apparatus is only available outside the GLP area) can be considered.
- When the SD considers a study phase can only be done with success in a non-GLP lab, an exemption should be asked before to the GLP monitoring authorities where the test facility is located and the MA where the testlab is located.
- For Belgium this can be done via the Non-GLP phase notification form
- The MA of the country can decide to do a (pre-) inspection in the non-GLP facility. Other countries agree that the phases are audited by QA and SD. Belgian MA will decide case by case or do it on request of the MA responsible for the test facility.
What is the recommended archive period for GLP study records and materials?
The GLP Principles specify the manner in which study materials should be archived but do not specify for how long these items should be retained. For some types of test items, the legislation relating to that type of chemical or product may specify a required archiving period and this should be complied with. Supporting records should be retained for as long as they may be required in order to support study data. Items that have a limited shelf-life are not expected to be retained beyond their likely usefulness.