『データインテグリティについて』

データインテグリティの要件は、医療機器企業にも適用されるのであろうか。
製薬業界では、2015年に英国のMHRAが『GMP Data Integrity Definitions and Guidance for Industry』を発出して、データインテグリティに火が着いた。
しかしながら、医療機器業界ではあまりデータインテグリティについては議論されていない。

もちろん、医療機器業界においてもデータインテグリティの要件は適用されると考えるのが正統ではあろう。
しかしながら、医薬品企業ほど重要ではないのである。

医薬品製造においては基本的に破壊検査が主体である。
そのため、サンプリングによる検査を実施することとなる。
サンプリングした製品の中でOOS(Out of Specification:規格外製品)が発見された場合、バッチ(ロット)ごと廃棄しなければならない可能性も発生し得る。
しかしながら高価な製品である場合、廃棄(経済的な損失)をためらい、試験データを改ざんしたり、クロマトグラムのプログラムを規格内になるように変更するといった不正を行う企業も少なからず存在する。
また不正によるデータの改ざんのみではなく、転記ミス、計算ミス、プログラムのバグなどによってもデータが意図せず変更されてしまうこともあるだろう。
医薬品といったその特性ゆえ、それらについて後工程である分析や出荷判定などで検出することは困難である。
理由の如何を問わずデータの意図しない変更が発生した場合、患者やユーザの安全性に多大な悪影響を及ぼしてしまう可能性がある。
そこで規制当局は製薬企業のGMPにおいてデータインテグリティの要件を課している。

一方において、医療機器は多くが非破壊検査が可能である。
つまり全品検査が可能なのである。
その場合、不適合品はリワーク(製造し直し)によって修正され、合格品となった場合、出荷することになる。
つまり、不正などによって検査データを改ざんする必要性がないのである。
そもそも不適合品を出荷した場合、返品されるか苦情となってしまい、返ってコストや手間がかかるだけだろう。
また、医薬品とは異なり、工程途中の転記ミス、計算ミス、プログラムのバグなどによるデータの意図しない変更も、最終検査などで比較的容易に検出することが出来るのである。
さらに医薬品とは異なり、患者やユーザが使用前に異常に気付くこともある。
このように医薬品と医療機器の検査方法と出荷判定プロセスの違い等により、データインテグリティ要件(患者・ユーザの安全性を優先する)が厳しく適用されるか否かが異なるのである。

【お知らせ】 

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