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共用施設における異なる医薬 ... - Welcome to ISPE

Page 1 / 10 EU-GMP PDE EMA ispe Containment COP ispe (ADE) 2012 12 13 EMA/CHMP/CVMP/SWP/169430/2012 Committee for medicinal products for human use (CHMP) Committee for medicinal products for veterinary use (CVMP) Safety Working Party ( ) 2012 12 CVMP 2012 11 CHMP 2012 12 13 2013 1 8 2013 6 30 Page 2 / 10.

Page 2 / 10 共用施設における異なる医薬品製造時のリスク特定において用いられる健康への影響に基づく 曝露限界の設定に関するガイドライン

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