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Good Laboratory Practice
Inspections
The core of the compliance-monitoring programme is a periodical inspection scheme, with an intended frequency of one inspection per 2 years. As circumstances require, the inspection schedule may be intensified.
A regular inspection has the following components:
- Interviews with management and Quality Assurance personnel
- Review of the documentation
- Inspection of facilities, equipment, test systems, procedures, practices etc.
- Audit of a number of studies
- Exit meeting, at which a List of Observations will be issued, if appropriate.
The duration of a regular inspection varies from 3 to 10 working days, in proportion to the size and workload of the test facility. Dependent on the findings at the inspection and, where appropriate, the remedial actions taken by the test facility, the company will be judged to operate “in compliance” or “not in compliance” with the GLP Principles. Incidentally the final judgement will be postponed till re-inspection and will then read “pending” for the time being. If a test facility is considered to operate in compliance with the OECD GLP Principles, an “Endorsement of Compliance” will be issued, as indicated in Directive 2004/9/EC. This endorsement only states that the facility was operating in compliance at the time of the inspection. It may be used for inclusion in study reports to indicate that the test facility has been inspected for GLP compliance with good results.
If a test facility is found to operate in compliance, it will be re-inspected on a biennial base. In the event of non-compliance the test facility will be re-inspected at its own instigation.
Annual overviews of the test facilities inspected, their GLP status and areas of expertise will be prepared each year and sent to the national regulatory authorities and foreign GLP monitoring authorities. The latest reports are available here:
- Domestic test facilities included in the GLP monitoring program
- Foreign test non-domestic facilities included in the GLP monitoring program
The result of an inspection is crucial: In case of “non-compliance” test results will in principle no longer be accepted by (inter)national regulatory authorities.
