適格性評価とは

適格性評価とは

手術をする際にメスがなかったとしよう。(あり得ないが…)
近所の高級刃物店で最高級のナイフを買ってきた。最高級なので当然品質は良いだろう。
しかしながら、高級なナイフは手術に適しているだろうか!?
答えは否である。

また、プラスネジを絞めたいけれど、プラスドライバーがないとしよう。プラスネジはマイナスドライバーでも締めることが出来るだろう。
しかしながら、これを繰り返せばネジ穴が潰れる可能性がある。さらに、ドライバー自体が破損する可能性もある。
これでは事故が起きてしまう。

使用目的(Intended Use)に機器等の仕様が合っていない場合、事故が起きるリスクがある。
規制要件では必ず「要求」に「仕様」を合わせることを要求しており、それらが合致したことを確認することを「適格性評価」(Qualification)と呼ぶ。
つまり、ハード(ハードウェアではない)に対するバリデーションのことを「適格性評価」と呼ぶ。
ハードは主にハードウェアでできている。当該ハードがソフトウェア(またはファームウェア、PLC等)で制御されている場合、コンピュータ化システム(または自動化システム)と呼ぶ。
その場合、当該ソフトウェアに対しても「適格性評価」(CSV)が必要である。

適格性評価(Qualification)はプロセスバリデーションで使用される用語であり、DQ(Design Qualification:設計時適格性評価)、IQ(Installation Qualification:据付時適格性評価)、OQ (Operational Qualification:運転時適格性評価、PQ (Performance Qualification:性能適格性評価などで構成される。
現代では、DQやPQは実施されないことが多い。
またPQはOQやプロセスバリデーション(PV)に含めても良い。
さらにIQとOQは同時実施することが認められており、IOQとして当該ハード(ソフトウェアを含む)の供給業者に委ねることが一般的となっている。

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