Checklist for GCP compliance investigation (Medical institution)

Japan Society of Quality Assurance, GCP Division

Authors

  • Kiyomi Hirayama,

    Corresponding author
    1. Quality Assurance Resources, Banyu Pharmaceutical Co. Ltd., AIG Kabutocho Building, 5-1, Nihom-bashi-Kabutocho, Chuo-ku, Tokyo 103-0026, Japan
    • Quality Assurance Resources, Banyu Pharmaceutical Co. Ltd., AIG Kabutocho Building, 5-1, Nihombashi-Kabutocho, Chuo-ku, Tokyo 103-0026, Japan
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  • Naohisa Fukuda,

    1. Quality Assurance, Pharmaceutical Development Division, Takeda Pharmaceutical Company Ltd., 4-1-1, Doshomachi, Chuo-ku, Osaka 540-8645, Japan
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  • Hitoshi Satoh,

    1. Clinical Quality Control Group, Development & Regulatory, Abbott Japan Co. Ltd., 5-25-5 Sendagaya, Shibuya-ku, Tokyo 151-8563, Japan
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  • Katsumi Itoh,

    1. Regulatory Audit, Fujisawa Pharmaceutical Co. Ltd., 1-6, Kashima 2-chome, Yodogawa-ku, Osaka 532-8514, Japan
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  • Kiyoshi Chiba,

    1. Quality & Regulatory Affairs Division, Quality Assurance Department, Kyowa Hakko Kogyo Co. Ltd., 1-6-1, Ohtemachi, Chiyoda-ku, Tokyo 100-8185, Japan
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  • Yutaka Nakae,

    1. Medical Quality Management Co. Ltd. 2-9-5-305, Ichikawa-Minami, Ichikawa 272-0033, Japan
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  • Masayuki Takezawa,

    1. Clinical Research Operations, Medical System Research Corp., Gracy Tenjinbashi Bldg. No2. 9F, 7-12-6 Tenjinbashi, Kita-ku, Osaka 531-0041, Japan
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  • Kuniko Gotoh

    1. Quality Assurance, Sankyo Co. Ltd., 2-58, Hiromachi 1-chome, Shinagawa-ku, Tokyo 140-8710, Japan
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Abstract

This checklist is an English translation of the Good Clinical Practice (GCP) compliance checklist prepared by the Japanese agency for on-site inspections of medical institutions. Please note that the checklist was translated by the authors and has not received official review by any Japanese agency including the Organization for Pharmaceutical Safety and Research (OPSR).

This checklist is an addendum to a previously published article on the evaluation of overseas GCP inspections by the Japanese Regulatory Agency [1]. Copyright © 2005 John Wiley & Sons, Ltd.

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