医薬品と医療機器の相違点について

筆者がコンサルティングを実施している中で、医薬品の規制と医療機器に関する規制の違いに直面することがある。
例えば、プロセスバリデーションやリスクマネジメントなどである。
同じ用語を使用しているが、医薬品企業と医療機器企業ではその実施方法が異なる。
今回は、医薬品企業と医療機器企業の差異を明らかにし、それぞれの規制要件の適切な理解をしたい。

1.品質保証について

筆者がコンサルティングを実施している中で、医薬品の規制と医療機器に関する規制の違いに直面することがある。
例えば、プロセスバリデーションやリスクマネジメントなどである。
同じ用語を使用しているが、医薬品企業と医療機器企業ではその実施方法が異なる。
今回は、医薬品企業と医療機器企業の差異を明らかにし、それぞれの規制要件の適切な理解をしたい。

2.リスクマネジメント vs 品質リスクマネジメント

医療機器の不具合は患者(使用者)にダイレクトに影響する。
しかしながら医薬品は、構造設備(製造に使用する設備、機器、システム等)の不具合が医薬品の品質に影響し欠陥が潜む。
欠陥のある医薬品を患者が服薬した際に健康被害が発生する 。
したがって、医療機器は「リスクマネジメント」を実施するのに対して、医薬品では「品質リスクマネジメント」(QRM:Quality Risk Management)を実施する。
つまりリスクがダイレクト(直接的)かインダイレクト(間接的)かが異なる。

3.医療機器は設計問題が最重要

医薬品の品質不良のほとんどが製造所の問題である。
例えば不純物混入やラベル間違い、個装の破損などである。
一方で、医療機器は例え製造が適切であっても、そもそも設計が間違っていると安全ではない。
また、たとえ設計が適切であったとしても、そもそもユーザ要求が間違っていることもある。

4.検査方法の違い

医薬品は破壊検査が基本であるため、サンプリングによりQCを実施する。
医療機器においては、多くが非破壊検査が可能である。
つまりサンプリングではなく、全品検査が可能である。
医薬品の場合、OOS(規格外:Out Of Specification)が発生した場合、バッチごと廃棄をせざるを得ない。
しかしながら、医療機器は不適合品のみを廃棄するか、 リワーク(手直し)した後に合格すれば出荷が可能である。

5.プロセスバリデーション

医薬品は破壊検査しかできないため、すべての工程に対してプロセスバリデーションが必要である。
一方、医療機器は後の工程で十分な検査ができない特殊工程(例:はんだ付け、滅菌、かしめ等)のみプロセスバリデーションが必要である。


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