Frequently Asked Questions

See Manual Belgian GLP compliance monitoring programme , chapter 4

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 € 148 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, € 2364 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, €661 (in situ inspection); for non-domestic facilities, €1231 (inspection of documentation).

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.

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.

Some computerized systems controlling older equipment do not have an audit trail function.

The use of such systems is allowed as long as all the following conditions are met:

• there is no technological alternative  available
• a well-documented risk analysis defines the risks induced by the absence of an audit trail on the quality and integrity of the data generated, analyzed and stored by the system;
• a risk mitigation strategy is introduced to reduce these risks in an acceptable way;
• the entire process is described in a SOP and well controlled and evaluated by the facility in the QAP

The archiving of an originally on paper generated document in electronic format is considered to be invalid. However, it is possible to keep a digital copy of a document that has been manually signed and scanned, as long as the original paper version of the document is archived. Archiving of the original paper document  can be done either at an outsourced contract archiving site, at the test facility (in the case of data generated on a test site), or even to the sponsor (if the sponsor has a GLP compliant archive).

In order for this electronic copy to be presented during inspections instead of the original, the scanning process must be established and validated up front, described in a SOP and verified to ensure that the scan is the exact copy of the original document. Tests should be included to ensure the protection of the scanned document so that it cannot be modified.

In addition, the electronic system implemented for the preservation of scanned documents must be validated.

The inspectors can nevertheless request the repatriation of the original data at any time, in particular to control the digitization process and the authenticity of the data.