GMP-Guideline-for-Drug-Products课件.pdf

添付資料 ４ GMP Guideline for Drug Products The Welfare and Labor Science Research in 2005 Report on “Study related to the concept of latest quality system and techniques for drugs” Yukio Hiyama, Ph. D., Chief Study Director Drug Department, National Institute of Health Sciences GMP Guideline for Drug Products - Study Group Members - Yasuto Koyama, Eli Lilly Japan K. K. , Director Yoshinori Ii, Ono Pharmaceutical Co., Ltd. Yuji Ishii, Shizuoka Prefectural Government Kazuhiro Kagawa, Tokyo Metropolitan Government Hiroshi Kawamura, Shizuoka Prefectural Government Yoshiaki Kii, Mercian Corporation Yoko Kurihara, Osaka Prefectural Government Yoshiaki Hara, Sartorius K. K. Yoshihiko Yanagihara, Ph. D., Pharmaceuticals and Medical Devices Agency 1 添付資料 ４ GMP Guideline for Drug Products Preface and Acknowledgment In the Welfare and Labor Science Research in 2003 “Study related to the concept of latest quality system and techniques for drugs” (chief study director: Yukio Hiyama, Ph. D.), our study group reported “A Proposal for Drug GMP Guidance.” For preparation of this guidance, “Draft Drug Product GMP Guideline” by Japanese Pharmaceutical Manufacturer’s Association” was used as a reference, and a lot of helpful comments were given by those concerned in the industry. In 2004 we issued “A Proposal for Drug GMP Guidance” to ask for public comments, and prepared this research report “GMP Guideline for Drug Products” based on a lot of ideas given by the GMP Committee of the F