適格性評価(Qualification)とは

ありえないことであるが手術をする際にメスがなかったとしよう。
メスの代わりに高級刃物店で最高級のナイフを買ってきたとしよう。
最高級のナイフであるからその品質は高いといえる。では最高級の品質のナイフは手術に適しているだろうか。
答えはNoである。
もしナイフで手術をしたとしたらとんでもない事故になるだろう。
つまり、使用目的と工具等の仕様が一致していなければ事故が起きてしまうのである。

別の例で解説しよう。読者が家庭においてプラスネジを締める際にプラスドライバーがなかったとしよう。
プラスネジはマイナスドライバーでも締めることはできる。
しかしである。プラスネジをマイナスドライバーで締めるとネジ穴を潰してしてしまうかも知れない。
またドライバー自体も破損することが考えられる。 
このように要求された仕様に対して設備、装置、システム等を適合させることが重要なのである。
医薬品製造における構造設備についても同様のことが言える。


原薬
GMPのガイドライン


平成13年に発出された「原薬GMPのガイドライン」(薬発第1200号)12.3 適格性評価には、以下の記載がある。
12.30 プロセスバリデーションの作業を始める前に、重要な装置及び付帯設備の適格性評価を完了すること。

適格性評価は、通常、以下の作業を個々に、又は組み合わせて実施する:
-設計時適格性評価(DQ):設備、装置又はシステムが目的とする用途に適切であることを確認し文書化すること。
-設備据付時適格性評価(IQ):据付け又は改良した装置又はシステムが承認を受けた設計及び製造業者の要求と整合することを確認し文書化すること。
-運転時適格性評価(OQ):据付け又は改良した装置又はシステムが予期した運転範囲で意図したように作動することを確認し文書化すること。
-性能適格性評価(PQ):設備及びそれに付随する補助装置及びシステムが、承認された製造方法及び規格に基づき、効果的かつ再現性よく機能できることを確認し文書化すること。

この原薬GMPのガイドラインにより、構造設備のバリデーションとは「適格性評価(Qualification)を行うことである」とその定義と内容が明確になった。
すなわち構造設備(ハード)を対象とするバリデーションを「適格性評価」と呼ぶ。
適格性評価は、DQ(設計時適格性評価)、IQ(設備据付時適格性評価)、OQ(運転時適格性評価)、PQ(性能適格性評価)から構成される。
また適格性評価はプロセスバリデーションの前に実施しておかなければならない。

ハード(設備、装置、システム等)に対するバリデーションのことを適格性評価(Qualification)と呼ぶ。
ハードは主にハードウェアでできている。ソフトウェア(またはファームウェア、PLC等)で制御されているハードをコンピュータ化システム(または自動化システム)と呼ぶ。
コンピュータ化システムの場合、適格性評価の一環としてCSVを実施する。CSVのみ単独で実施することは困難である。
適格性が確認できたハードに対し、ソフト(手順書、教育訓練、校正、メンテナンス等)を加えてプロセスバリデーションを実施する。

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