Test article analyses in compliance with good laboratory practice in Japan: circumstances and changes

In Japan, many test facilities have been inspected by the monitoring agency since 1984 and inspectors pointed out some issues for improvement. The interest in test article analyses in support of Good Laboratory Practice (GLP)-compliant studies has been rising for the last several years. This paper reports the advice and indications for improvement that were pointed out for test article analyses by the Japanese monitoring agency. In addition, the Japan Society of Quality Assurance (JSQA) conducted surveys using a questionnaire form in 2001 and 2004 in order to understand the present situation and the changes in Japanese test facilities that belong to the member companies of the GLP division of the JSQA. From the results of surveys, it was found that test article analyses have been performed under GLP, reflecting the requirements of the monitoring agency. Copyright © 2007 John Wiley & Sons, Ltd.