Division Follow-up to test facility inspections and study audits

When a test facility inspection or study audit has been completed, the inspector should prepare a written report of the findings.

Member States should take action where deviations from GLP principles are found during or after a test facility inspection or study audit. The appropriate actions should be described in documents from the (national) GLP Monitoring Authority.

If a test facility inspection or study audit reveals only minor deviations from GLP principles, the facility should be required to correct such minor deviations. The inspector may need, at an appropriate time, to return to the facility to verify that corrections have been introduced.

Where no, or where only minor deviations have been found, the (national) GLP Monitoring Authority may:

• issue a statement that the test facility has been inspected and found to be operating in compliance with GLP principles. The date of the inspections and, if appropriate, the categories of test inspected in the test facility at that time should be included. Such statements may be used to provide information to (national) GLP Monitoring Authorities in other OECD member countries,

  and/or

• provide the Regulatory Authority which requested a study audit with a detailed report of the findings.

Where serious deviations are found, the action taken by (national) GLP Monitoring Authorities will depend on the particular circumstances of each case and the legal or administrative provisions under which GLP compliance monitoring has been established within their countries. Actions which may be taken include, but are not limited to, the following:

• issuance of a statement, giving details of the inadequacies or faults found which might affect the validity of studies conducted in the test facility,

• issuance of a recommendation to a Regulatory Authority that a study be rejected,

• suspension of test facility inspections or study audits of a test facility and, for example and where administratively possible, removal of the test facility from the (national) GLP compliance programme or from any existing list or register of test facilities subject to GLP test facility inspections,

• requiring that a statement detailing the deviations be attached to specific study reports,

• action through the courts, where warranted by circumstances and where legal/administrative procedures so permit.