Test facilities are included in the GLP compliance monitoring programme at their own request or at the request of a receiving/regulatory authority. A test facility should inform the Inspectorate that it applies the Principles of GLP in safety studies. In case of failure to do so the Inspectorate will inform national and international GLP authorities that the GLP status of the test facility can not be confirmed and therefore its study results should be refused.
Foreign test facilities may apply for inspection if:
- they can proof that their study reports will be submitted to a receiving/regulatory authority in the Netherlands;
- there is no internationally recognized GLP compliance monitoring programme in their own country;
- they agree to bear the full costs of the inspection.
List of test facilities
A list of test facilities which are subject to inspection is produced each year. It states the current GLP status of the test facilities and their area(s) of expertise. The list is circulated to all receiving/regulatory authorities in The Netherlands and to GLP compliance monitoring authorities in other countries.
Monitoring of GLP compliance is a national task of the government but one with international relevance. All OECD member states are required to accept each other’s safety test data, provided it has been produced in accordance with the Principles of Good Laboratory Practice and an internationally accepted system of GLP compliance monitoring is in place in the originating country.
The national and international receiving/regulatory authorities as well as those responsible for monitoring compliance with GLP are entitled to request ‘study audits’. A study audit is a particularly thorough assessment of one or more studies, in which the entire research procedure is reconstructed on the basis of the study plan, raw data, interim findings, the final report and other relevant documentation.