The OECD Principles of Good Laboratory Practice (GLP) set out managerial concepts covering the organisation of test facilities and the conditions under which pre-clinical safety studies are executed. Their purpose is to ensure the generation of high quality and reliable test data (in vitro and in vivo) related to the safety of chemicals and preparations in the framework of the Mutual Acceptance of Data (MAD).

 

The OECD Principles of GLP are an integral part of the 1981 Council Decision on the Mutual Acceptance of Data in the Assessment of Chemicals (revised 1997). MAD also harmonises procedures of GLP compliance monitoring, ensuring that pre-clinical safety studies are carried out according to the Principles of GLP and that countries can have confidence in the quality and rigour of safety tests.

 

The 1989  Compliance with Principles of Good Laboratory Practices requires the establishment of national compliance monitoring programmes based on laboratory inspections and study audits. It recommends the use of the Guides for Compliance Monitoring Procedures for Good Laboratory Practice and the Guidance for the Conduct of Laboratory Inspections and Study Audits .

 

Since 1997 a procedure through which non-OECD countries can adhere to the MAD system has been embodied in a Council Decision (Council Decision on the Adherence of Non-Member Countries to the Council Acts Related to the Mutual Acceptance of Data in the Assessment of Chemicals C(97)114/FINAL ). There are currently several non member economies in various stages of adherence.

 

A series of documents related to specific issues of GLP and compliance monitoring has been published.