Good Laboratory PracticePrinciples, Compliance and Mutual Recognition

Government and industry are concerned about the quality of non-clinical health and environmental safety studies upon which hazard assessments of chemicals and chemical products are based. As a consequence, OECD member countries have established criteria for the performance of these studies. Chemicals control legislation in is generally founded in a... read moreproactive philosophy of preventing risk by testing and assessing chemicals to determine their potential hazards. The requirement for evaluations of chemicals to be based on safety test data of sufficient quality, rigor and reproducibility is a basic principle in this legislation.

To avoid different schemes of implementation that could impede international trade in chemicals, OECD member countries have worked together toward international harmonisation of test methods and good laboratory practice for over 40 years. The OECD Principles of Good Laboratory Practice (GLP) were developed at the end of the 1970s to ensure the quality and validity of test data used for determining the safety of chemicals and chemicals products in its member countries. They embody a managerial concept covering the organizational processes and the conditions under which non-clinical environmental, health and safety studies are planned, performed, monitored, recorded and reported. The OECD Principles of GLP are an integral part of an OECD Council Decision on the Mutual Acceptance of Data in the Assessment of Chemicals which is legally binding to OECD and adhering non–member economies. The OECD Principles of GLP must be followed by test facilities carrying out studies to be submitted to national data receiving authorities if those studies are to be accepted in other OECD or adhering countries for regulatory purposes. If individual countries can confidently rely on test data developed in other countries, duplicative testing can be avoided, thereby saving time and resources.

The issue of data quality in the assessment of chemicals has an important international dimension. If regulatory authorities in member countries can rely on safety test data developed abroad, duplicative testing can be avoided and costs saved for both government and industry. In addition to the common Principles for GLP for test facilities, OECD has developed common procedures for governments to monitor compliance with them, facilitate the exchange of information and prevent the emergence of non–tariff barriers to trade, while contributing to the protection of human health and the environment.

The 1989 OECD Council Decision-Recommendation on Compliance with GLP together with the 1982 Council Decision on the Mutual Acceptance of Data (MAD) in the Assessment of Chemicals and the 1995 Council Decision on the Adherence of Non-Members to the OECD Council Acts related to MAD sets the legal framework for international liaison for this area. This talk series will cover the Principles of GLP, which are an integral part of the 1982 Council Decision and the only international standard for non–clinical health and environment safety studies, as well as the compliance monitoring procedures used in OECD and adhering countries and the international framework which ensures mutual recognition among governments of national compliance monitoring programmes, and, thus, safety data submitted from abroad for regulatory purposes.