Good Laboratory Practice for Safety Evaluation as OECD Guide and Malaysia Initiative

Author

Hasenah Md Ali

Proceeding

Traditional & Complementary Medicine Exhibition 2007 (TCME 2007), Putra World Trade Centre (PWTC), Kuala Lumpur, Malaysia

Date

17/7/2007

Keyword

Data not available

Abstract

The Organization for Economic Co-operation and Development (OECD) is an intergovernmental organization consisting of thirty industrialized countries. Its main task is to monitor economic trends in those countries. One important element of the OECD work is the system for Mutual Acceptance of Data (MAD).  Through the MAD, OECD countries and participating non member countries agree to mutually accept data generated in the testing of chemicals in accordance with the OECD Test Guidelines and Principles of GLP for purposes of assessment and other uses relating to the protection of man and the environment. This means that data generated under these conditions in one country does not need to be reproduced for purposes of assessing the chemical in other country.  Common principles of GLP 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.  By being a non-member to OECD and adhering to the MAD, all safety studies conducted in Malaysia will be accepted in all OECD countries. OECD Principles of GLP includes Test Facility Organization and Personnel, Quality Assurance Programme, Facilities, Apparatus, Materials and Reagents, Test System, Test and Reference Item, Standard Operating Procedures, Performance of the Study, Study Report and Archiving of records and materials.