Monitoring Good Laboratory Practices (GLP) in Belgian test facilities
The GLP principles are guidelines enacted by the OECD. As such, they are legally binding in all OECD countries and are taken over in the European regulations. When Belgian test facilities report they comply with the OECD Good Laboratory Practices (GLP) for running a non-clinical study, we assess whether they fully implement the principles for its proper conduct.
Our job only applies to non-clinical trials and to some experiments which have not been submitted yet to the appropriate regulatory authorities. Moreover, we only intervene if the tests are run in a laboratory or in an environment specifically designed to provide data about their properties and/or safety.
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We perform 2-yearly “on-site” inspections to assess the test facilities’ procedures and practices, as well as their degree of compliance with the GLP principles. During the inspections, we review the management structures and operational procedures of the tests, we interview key technical staff members and we evaluate the quality and the integrity of the data generated by the inspected facilities.
Additionally, we realise ‘Study Audits’ by comparing raw data and associated records with the interim and final reports published. We determine whether:
- the raw data have been accurately reported
- the tests were carried out in accordance with the study plan and Standard Operating Procedures (SOP).
Our goal is to get information which is not provided in the reports and to evaluate whether the practices used to get the data are likely to impair their validity.
The conclusions of our inspections serve as a base to grant or refuse a GLP certification to the inspected facilities, to declare some or all of their studies as being non-compliant and, in some cases, to trigger a legal action at a court. We keep all OECD countries informed about the outcome of each inspection.
You can find further information about GLP principles on the website of the Belgian GLP monitoring authority.