Division Introduction

The purpose of this part of this Annex is to provide guidance for the conduct of test facility inspections and study audits which would be mutually acceptable to OECD member countries. It is principally concerned with test facility inspections, an activity which occupies much of the time of GLP inspectors. A test facility inspection will usually include a study audit or review as a part of the inspection, but study audits will also have to be conducted from time to time at the request, for example, of a Regulatory Authority. General guidance for the conduct of study audits will be found at the end of this Annex.

Test facility inspections are conducted to determine the degree of conformity of test facilities and studies with GLP principles and to determine the integrity of data to assure that resulting data are of adequate quality for assessment and decision-making by national Regulatory Authorities. They result in reports which describe the degree of adherence of a test facility to the GLP principles. Test facility inspections should be conducted on a regular, routine basis to establish and maintain records of the GLP compliance status of test facilities.

Further clarification of many of the points in this part of this Annex may be obtained by referring to the OECD consensus documents on GLP (on, e.g., the role and responsibilities of the study director).