Seung Hee Maeng

HISTORY OF THE KOREAN GLPs AND THE ACTIVITIES AND PERSPECTIVES OF THE KOREAN SOCIETY OF GLP

The Korean Society of Good Laboratory Practice (KSGLP) was established Dec. 10, 1998. The objectives of the KSGLP are to enhance the quality of domestic studies and the level of GLP compliance, in safety testing, and to promote information exchange among its members. The activities of KSGLP include: offering workshops and symposiums, linking with related governmental organizations, collecting GLP related information and providing the information to the related organizations, building international networks to collect information and to establish relationship, developing training materials and publishing periodicals, and other business necessary to achieve the objectives of the KSGLP. The KSGLP achieved its goals within a short period of time by offering workshops and symposia, and by providing important GLP related information in newspapers or via the KSGLPs internet homepage (www.ksglp.or.kr). The main role of the KSGLP will be to disseminate GLP technology nationwide. The KSGLP would like to help many labs that are preparing their facilities for GLP compliance. Further, the KSGLP is hoping to share GLP experiences with other members.

DESIGNATION OF A GLP FACILITY BY THE KOREAN MINISTRY OF ENVIRONMENT GLP AUTHORITY: THE CASE OF THE CENTER FOR OCCUPATIONAL TOXICOLOGY

In this report, the process of designating a GLP facility by the Korean Ministry of Environment (MOE) is described in detail using the case of the Center of Occupational Toxicology (COT). The COT, which had been prepared as a GLP facility, filed an application to the National Institute of Environmental Research (NIER) of the MOE. The GLP system of the COT was evaluated by a harmonized evaluation team that consisted of several authorities including the NIER, the National Institute of Agricultural Science and Technology (NIAST), and the National Institute of Toxicological Research (NITR). The evaluation was arranged for mutual acceptance of data among GLP authorities. The designation process, additional documents necessary for applying GLP facility, the process of test facility evaluation including reviewing the application and site inspection, and inspection results and submission of correction plans are explained by using the instance of the inspection process of the COT. COT was evaluated as a suitable GLP facility for acute oral and inhalation toxicity tests and the Ames test.