Self Inspectionの重要性

PIC/S GMPの第9章はSelf Inspectionである。本邦の規制要件等(GMP省令、GVP省令等)ではSelf Inspectionを「自己点検」と訳している。しかし、筆者はこの訳は適切ではないと感じている。
当局による査察であるAuthority Inspectionに対して Self Inspection は企業が自らを査察することである。つまり「自己点検」ではなく「自己査察」、すなわち「内部監査」のことである。
Self Inspectionは、内部監査の他、外部監査、定期レビュ、マネージメントレビュなどからなる。

当局査察は数年おきで、しかも数日間実施されるのみである。そこで指摘された事項のみを改善したとしても、患者の安全性や製品の品質は担保できない。
大事なことは、当局査察がなくとも、自らが自らを“査察”し、“指摘”し、“改善”することである。
Self Inspectionの重要性を再認識されたい。

監査員の力量
筆者は製薬企業にかかわらず、医療機器企業や医療機関、諸外国の原薬工場等の査察・監査に対するコンサルティングをするが、監査員の能力が非常に低いことに驚く。
例えば、監査員に製造経験がなく、製造に関するリスクの指摘が全くできないケースがあった。
監査報告書を見ていると教育記録についてのみ指摘していた。
これでは製造プロセスの品質向上やリスクの低減は望めない。
ひどいケースでは、転記ミスやエラーの指摘ばかり行っている監査があるが、これでは本末転倒である。
文書の書き方を修正したところで品質保証にはならない。これらの指摘は、患者の生命・健康の担保にはまったく関係のないことであり、そのような指摘を出すような企業では規制当局は安心できない。
したがって、監査員は当該プロセスのプロでなければならない。
つまり、製造を監査する監査員は製造の経験者でなければならない。
また品質試験を監査する監査員は品質試験の経験者でなければならない。
その上で最新の規制要件等の要求事項を適切に理解していなければならない。

洞察力を持って指摘し、根本的原因を発見し、それらをつぶして再発を防止する。
またたとえ問題が起きていなくとも、品質システムや組織などに潜むリスクを発見し指摘しなければならない。
監査員にはこのように非常に多くの能力が必要である。

監査員に適した人材
最近でこそ日本の企業も色々な会社から異動・転職してくる方が増えたが、生え抜きの人間には監査は困難である。
なぜならば自らの経験したやり方しか知らないからである。つまり、自社のプロセスを是としているためである。

規制当局の査察官、筆者のようなコンサルタントは多くの企業のプロセスを見てきている。そのため、他社とのベンチマークにより、問題点やリスクの発見が比較的容易である。他社(Best Practice)と比べ足りていない箇所があればそれがリスクであると判断できる。
また転職者には、前職でのプロセスと比較することが出来る。
適切な監査の実施のためには、こういった比較対象の有無や、さらに洞察力も必要となるため、生え抜きの人には難しいのである。
また、監査員はきちんと指摘して改善をさせるという能力も必要となる。

そのためには監査員は、他人に批判されることを恐れず、上下関係に問わず皆に平等でなければならない。
監査は常に独立性と公平性が求められるのである。

GMP省令における自己点検
GMP省令の第18条が自己点検である。
下記の要求がある。

製造業者等は、あらかじめ指定した者に、手順書等に基づき、次に掲げる業務を行わせなければならない。

一 製造・品質関連業務について定期的に自己点検を行うこと。
二 自己点検の結果を品質保証に係る業務を担当する組織および製造管理者に対して文書により報告すること。
三 自己点検の結果の記録を作成し、これを保管すること。
2 製造業者等は、前項第1号の自己点検の結果に基づき、製造・品質関連業務に関し改善が必要な場合においては、所要の措置をとるとともに、当該措置の記録を作成し、これを保管すること。

また、逐条解説には、下記の事項が解説されている。

  • 自己点検責任者を設置すること。
    • 自己点検責任者は、自己点検の対象となる業務の内容を熟知している職員であること。
    • 自己点検責任者は、当該自己点検の対象となる業務に従事していない、客観的な立場にあること。
  • 自己点検に係る業務の一部を外部委託業者に委託する場合、適切な管理を実施すること。
  • 自己点検報告書(または自己点検記録書)を作成すること。
  • 自己点検の結果を品質保証部門および製造管理者へ文書により報告すること。
  • 製造管理者は自己点検報告書の結果により適切な処理を実施すること。
    • 責任者の適切な配置
    • 人員の十分な確保
    • 管理体制の整備
    • その他必要な資源の配分
    • 教育訓練

自己点検の対象(GMP省令の場合)

  • 製造管理者の業務
  • 医薬品製品標準書および手順書の作成等
  • 交叉汚染の防止措置
  • 構造設備の保守、点検等
  • 製造管理業務
  • 試験検査業務
  • 品質保証業務
  • 安定性モニタリング
  • 製品品質の照査
  • 原料等の供給者の管理
  • 外部委託業者の管理
  • 製造所からの出荷の管理
  • バリデーション
  • 変更管理
  • 逸脱管理
  • 品質情報および品質不良等の処理
  • 回収等の処理
  • 教育訓練
  • 文書および記録の管理
  • 文書および記録の保管
  • データインテグリティ

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