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

• Published in: Quality assurance (San Diego, Calif.) Calif.), 2000-01, Vol.8 (1), p.11-17
• Main Authors: Yu, Il Je, Maeng, Seung Hee, Lee, Jun Yeon, Lee, Yong Mook, Chung, Ho Keun
• Format: Article
• Language: English
• Subjects: Documentation; Environmental Health; Government Agencies - organization & administration; Korea; Laboratories - organization & administration; Laboratories - standards; Licensure; Occupational Exposure - analysis; Organizational Case Studies; Quality Assurance, Health Care; Toxicity Tests
• ISSN: 1052-9411; 1521-0677
• DOI: 10.1080/105294100753209156

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.