Mirror PDF: ゼロから学ぶGMP 仮想査察事例を徹底解説

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Title:Mirror PDF: ゼロから学ぶGMP 仮想査察事例を徹底解説
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●査察官の視点-仮想の指導事例からGMPを学ぶ- 製造管理、及び品質管理の基準であるGMP(Good Manufacturing Practice)に関する薬学部での講義はごくわずかで、薬剤師国家試験での出題も少ない。しかし、製薬企業に就職すると、製造所で製造管理や品質管理、品質保証といったGMP管理に携わる可能性があり、本社勤務では製造委託先の製造所のGMP管理状況をチェックする業務もあります。一方、行政側でも高品質の医薬品の製造を目指し、製造所のGMPの管理状況を確認するGMP査察官が、独立行政法人医薬品医療機器総合機構(PMDA)の品質管理等部門や各都道府県の薬務主管部局で活躍しています。 本書は、学生時代からGMPの基礎からその思想、サイエンスベースで医薬品の品質について学べる機会を提供するとともに、近年注目を集めているGMPの国際調和への動き、再生医療等製品の品質管理や偽造薬への対応など幅広く取り上げています。著者は長年PMDAの品質管理部での業務に携わっており、さらにGMPに関する厚生労働科学研究(レギュラトリーサイエンス分野)の研究代表者も務めてきています。 本書の構成は、厚労科学研究で作成した文書や記載事例、PMDAが講演会等で公表した情報や仮想の指摘事例などを利用して、GMPの必須要件や現場での活用方法が身につく内容となっています。薬学生や、企業でGMP関連業務を始める社員、あるいは行政のGMP査察官にも最適な一冊です。.
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