品質リスクマネジメントとは

医療機器においては「リスクマネジメント」が適用される。
一方で、医薬品に関しては「品質リスクマネジメント」(QRM:Quality Risk Management)が適用される。
では、いったい「品質リスクマネジメント」とは何であろうか?
医薬品の製造工程において、構造設備等の故障や逸脱などによって製品の品質に欠陥が生じる。品質に欠陥の生じた医薬品を患者が服薬した際にどのような健康被害が生じるのかを推定しなければならない。
つまり「品質」を介したインダイレクト(間接的)なリスクマネジメントなのである。
医療機器のリスクマネジメントとはダイレクトであるのに対して、医薬品はインダイレクトである。
したがって、リスクの推定は極めて難しい。
例えば、異物の混入によってどのような健康被害(死亡、重篤、入院、加療等)が生じるかを推定しなければならないのである。
またリスクは試すことができない。
例えば、異物を混入してみて患者にどのような健康被害が生じるかを試すわけにはいかないのである。
「品質リスクマネジメント」はいわばナレッジマネジメントである。
あらゆる科学的なエビデンスを集約して、十分にリスクを検討することが望まれる。
2021年8月に施行された改正GMP省令においても、「品質リスクマネジメント」の概念を各手順書に組み込むことが求められている。

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