製薬企業および医療機器企業において、CAPA(是正処置・予防処置)を導入することは至上命題である。
医療機器業界においては、ISO-13485およびQMS省令などでCAPAが要求されており、程度の差こそあれども、どの企業もインプリメントは終えているはずだ。
しかしである。製薬企業ではまだCAPAを導入していない企業が多くある。というよりもCAPA自体を知らない企業も存在する。
その理由は、GMP省令などの本邦の規制要件でCAPAが要求されていないためである。米国では、cGMPには直接記載がないものの、2006年に発行された「cGMPの品質システムからのアプローチ」と呼ばれるガイダンスにおいて、CAPAを要求している。
また欧州においても、PIC/S GMPでCAPAが明確に要求されている。
本邦において、唯一記載があるのは、2010年に課長通知として発出されたICH-Q10「医薬品品質システム」のみである。(下図参照)

筆者がコンサルテーションを実施する中で、是正処置は分かるが予防処置がよく分からないという声を耳にすることが多い。
ISO-9001:2008においては、予防処置とは「起こり得る不適合またはその他の望ましくない起こり得る状況の原因を除去するための処置」と定義されていた。
ここで、「起こり得る不適合」とはまだ起きていない問題のことであり、つまり「リスク」のことである。
つまり「予防処置」とは「リスク管理」のことなのである。
そこでISO-9001:2015においては、予防処置という箇条がなくなった。その代わりに各箇条に「リスク管理」としてばらまかれている。
つまり、予防処置は特定の組織や手順書で対応するものではなく、各組織が各手順書においてリスク管理として実施しなければならないということである。
製薬業界や医療機器業界のように、大きなリスクを持つ製品を製造する企業においては、今後、リスク管理の重要性はますます高まってくるものと思われる。
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