バリデーションをすればベリフィケーションは不要か

バリデーションをすればベリフィケーションは不要か

これまで何度も述べてきた通り、バリデーションとは、将来的に設計品質どおりの製品が製造できることを証明することであり、ベリフィケーションとは、設計品質どおりの製品が製造できたことを確認することである。
つまり「バリデーション」は未来形、「ベリフィケーション」は過去形である。

医療機器の場合、主に特殊工程においてプロセスバリデーションの実施が求められる。
特殊工程とは、破壊検査を伴う工程のことである。破壊してしまえば、製品として出荷できなくなるため、必然的にサンプリング(抜き取り)検査となってしまう。つまり、製造後に全数のベリフィケーションが出来なくなるため、あらかじめバリデーションを実施しなければならないのである。
特殊工程の例としては、半田付け、滅菌、かしめ、溶接、圧着、接着などがある。
筆者は、しばしばプロセスをバリデーションすれば、ベリフィケーションは不要かという質問を受けることがある。答えは否である。
バリデーションは、当該プロセスで製造する製品が製品規格内に収まるように高度に保証することを言う。
しかしながら、バリデーションされたプロセスで製造したとしても、構造設備の故障や、日常的なヒューマンエラー(勘違い、思い込み等)などが発生することもある。
また構造設備が経年劣化する恐れもあるのである。
従って、バリデートされたプロセスにおいても、出荷検査等において、抜き取りでベリフィケーションを実施することが望ましい。
例えば、滅菌工程における無菌検査や包装におけるシーリングのバースト検査などである。

https://www.youtube.com/watch?v=7FPgYRLcRcs

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