Daiichi developed its own good laboratory practice (GLP) guidelines before either the Food and Drug Administration (FDA) or the Japanese Ministry of Health and Welfare (MHW) enacted their GLPs. This paper covers Daiichi's GLP, and how the company uses quality assurance to meet its own, MHW, and FDA GLPs.
Drug Approval and Licensing Procedures in Japan. Chapter 8 GLP. Tokyo: Yakugyo Jiho Co., LTD; 1991.
2.
Editorial Supervision by Pharmaceutical and Cosmetics Div., the Pharmaceutical Affairs Bureau, the Ministry of Health and Welfare. GLP Kaisetu. Tokyo: Yakuji Nippo, LTD.; 1989.
3.
Daiichi Pharmaceutical Company.D-GLP Control Internal Rules. 1991.
