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 Environmen...

Full description

Saved in:
Bibliographic Details
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
Citations: Items that this one cites
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary: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.
ISSN:1052-9411
1521-0677
DOI:10.1080/105294100753209156