“state-of-the-art”とは「最新技術の、最も進んだ」という意味である。
これまで医薬品企業・医療機器企業は、他の産業に比べて自動化システムやITシステムの導入に遅れてきた。
その理由は何といっても例えばバリデーションのような規制要件による障壁である。
しかしながら“state-of-the-art”は最新鋭の装置・システムだけの話ではない。
規制当局の期待は、常に最新の情報を取り入れて品質システムを向上させ、製品の設計・製造工程・リスク分析等を見直すことなのである。
つまり“state-of-the-art”には、下記のような知見が含まれる。
・最新の規制要件
・最新の国際規格（ISO、IECなど）
・最新の安全性情報（有害事象、事故報告など）
・最新の他社情報（回収報告など）
・最新の治療方法（他の治療法など）
・最新のテクノロジー（構造設備、分析機器など）
企業は、開発が完了し製造段階に入ると、根本から設計（工程設計）・製造・リスク分析等を見直すようなことはほとんどない。
しかしながら、もっと良い方法、他社の失敗事例、最新のリスクなど取り込まなければならない情報は多く存在する。 今後は企業が“state-of-the-art”をどのようにモニタリングし、自社のプロセスにフィードバックしているかが問われることになるだろう。
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