Directive 2004/9/EC of the European Parliament and of the CouncilShow full title

Completion of inspection or study audit U.K.

When a test facility inspection or study audit has been completed, the inspector should be prepared to discuss his findings with representatives of the test facility at a closing conference and should prepare a written report, i.e., the inspection report.

A test facility inspection of any large facility is likely to reveal a number of minor deviations from GLP principles but, normally, these will not be sufficiently serious to affect the validity of studies emanating from that test facility. In such cases, it is reasonable for an inspector to report that the facility is operating in compliance with GLP principles according to the criteria established by the (national) GLP Monitoring Authority. Nevertheless, details of the inadequacies or faults detected should be provided to the test facility and assurances sought from its senior management that action will be taken to remedy them.

The inspector may need to revisit the facility after a period of time to verify that necessary action has been taken.

If a serious deviation from the GLP principles is identified during a test facility inspection or study audit which, in the opinion of the inspector, may have affected the validity of that study, or of other studies performed at the facility, the inspector should report back to the (national) GLP Monitoring Authority. The action taken by that Authority and/or the Regulatory Authority, as appropriate, will depend on the nature and extent of the non-compliance and the legal and/or administrative provisions within the GLP compliance programme.

Where a study audit has been conducted at the request of a Regulatory Authority, a full report of the findings should be prepared and sent via the relevant (national) GLP Monitoring Authority.