シニアマネジメントはGMPの責任を負うか

2016年12月13日、デンマーク当局(DKMA)による査察(内部告発による)で、Europharmaという会社の重大なGMPコンプライアンス違反が露見した。
再包装された医薬品の有効期限を改ざんしていたのである。
当局は同社に対し、製品の製造および輸入の禁止を命じた。
また、当局は「CEOの交替」を要求した。
会社の不正はトップの責任だという当局の考えの表れが強く出ているケースである。

このデンマークの事例が示すように、過去にEUの当局は、品質の低下に責任を持つために、有資格者(Qualified Persons:QPs)に焦点を当ててきた、しかし、多くの企業では、QPはシニアよりもむしろ中間管理職が務めている。
2008年のICH Q10 「医薬品品質システム」(PQS)ガイドラインにより、上級管理職が最終的に効果的な医薬品品質システムを確保する責任を負うという新しい考え方が支持された。
これは後にEU-GMPガイドラインの更新に反映されている。
EU GMP Annex 16 「QPの承認およびバッチリリース」には、医薬品のライフサイクル、安全性、品質および有効性に対する最終的な責任は、マーケティング認可保有者(MAH)にあると記載されている。

(注)QPはEU圏の規制であるため、PIC/S GMP Annex 16は存在せず欠番である。

しかし、QPは、マーケティング認証(MA)の要件およびGMPの要件に従って、認証が行われる加盟国における有効な法律に従って、個々のバッチが製造され、チェックされていることを保証する責任がある。

デンマークの当局(DKMA)は、この上級管理責任を面白いやり方で強化する行動をとった、つまりCEOを引責辞任させたのである。

今まではQPに責任を着せがちだったが、PQS(Pharmaceutical Quality System)の最終責任はシニアマネジメントにあるということである。

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