バリデーションの考え方の誕生

バリデーションの考え方の誕生 バリデーションの考え方は、1970年代に米国で発生した大容量注射剤に起因する薬害死亡事故が契機となっている。
問題の注射剤は製造工程で滅菌処理され、出荷試験時には無菌試験に適合していた。
メーカーは試験適合を確認して出荷したが、この製品を投与された患者が死亡する事故が相次いで発生した。
事故の原因は、菌で汚染されていた水を冷却水として使用したため、加熱滅菌処理したバイアルの内部は減圧状態となり、汚染された水がバイアルとゴム栓の隙間を通って内容液を汚染させた。
出荷試験は、無菌試験の抜き取り試験であり、全数を対象として実施していなく、汚染されたバイアルの存在を検出できなかったのである。
この事故から米国FDAは、最終製品の品質に注目するだけではなく、製造工程でも品質が確保されていることを保証する必要性に気づき、バリデーションの概念を法規に取り入れることとした。

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