The Health Care Inspectorate visits test facilities to verify that safety studies are being conducted in accordance with the GLP requirements. The on-site inspections are comprehensive and may last three days to two weeks depending on the size of the test facility.
A typical full inspection has the following components:
- interviews with management and quality assurance personnel;
- review of documentation;
- inspection of facilities, equipment, test systems, procedures, practices, etc.;
- audit of a number of studies;
- exit meeting at which a list of shortcomings is issued, if appropriate.
Inspections are conducted in accordance with the Guide for Compliance Monitoring Procedures of the OECD, which is annexed to Directive 2004/9/EC. The full text of this Directive and the accompanying product-related legislation can be found here.
Based on the inspection findings a decision on the compliance status of the test facility will be taken. The test facility can be judged to operate either ‘In Compliance’ or ‘Not in Compliance’. In some cases, a re-inspection will be deemed necessary before a final decision regarding the compliance status can be taken. Until the re-inspection is completed the status of the test facility will be labeled as ‘Pending’.
If the test facility is found to operate in compliance with the Principles of GLP, an ‘Endorsement of Compliance’ will be issued. In that case the test facility will be inspected again after about two years.
Not in Compliance
In case of ‘non-compliance’ test data will not be accepted by national and international receiving/regulatory authorities.
Under Article 7:1 of the Algemene wet bestuursrecht (General Administrative Law Act 1992 and amendments), a research institute can appeal the Inspectorate’s decision. It must do so in writing, addressing all correspondence to: The Ministry of Health, Welfare, and Sport (VWS), Directorate of Legal Affairs, P.O. Box 20350, 2500 EJ The Hague.
The appeal must be received by the ministry within six weeks and one day of the date shown on the Inspectorate’s notification. It must be signed by a duly authorized representative of the institute and must include the name and contact address of that representative, the date, and enough information to allow the contested decision to be identified, such as the case number, reference number(s) of previous correspondence or, preferably, a copy of the notification itself. The letter must also set out the grounds for appeal in full.