DIの継続的改善とは

データインテグリティの継続的改善と

GMP省令 第20条第2項は、本邦においてもデータインテグリティを確保するため、2021年の改正により新設された箇条である。

第20条 文書及び記録の管理
2 製造業者等は、手順書等及びこの章に規定する記録について、あらかじめ指定した者に、第8条第2項に規定する文書に基づき、次に掲げる業務を行わせなければならない。
一 作成及び保管すべき手順書等並びに記録に欠落がないよう、継続的に管理すること。
二 作成された手順書等及び記録が正確な内容であるよう、継続的に管理すること。
三 他の手順書等及び記録の内容との不整合がないよう、継続的に管理すること。
四 手順書等若しくは記録に欠落があった場合又はその内容に不正確若しくは不整合な点が判明した場合においては、その原因を究明し、所要の是正措置及び予防措置をとること。
五 その他手順書等及び記録の信頼性を確保するために必要な業務。
六 前各号の業務に係る記録を作成し、これを保管すること。

上記の通り、第1号から第3号において、データインテグリティ対応は、継続的に管理することが求められている。

アウェアネスにより多くの問題に気付く

警察官を増員すれば、駐車違反が増える。また警察官を増員すれば、スピード違反が増える。これは、駐車違反をする人が増えた訳でもなく、スピード違反をする人が増えた訳でもない。検出する機会が増えたのである。
また、MRを教育すれば、有害事象の報告数が増える。これも同様に有害事象そのものが増えたのではなく、気付きが増えたためである。
同様にデータインテグリティに関しても、データインテグリティ違反が無いと思っていて無いのか、本当に無いのかは詳細に精査してみなければ分からないのである。
まずは、データインテグリティを脅かす各種のリスク(転記ミス、入力ミス、計算ミス、操作ミス等)を抽出し、過去におけるデータの信頼性を再確認してみる必要がある。
各プロセスのリスクに気付けば、データインテグリティ違反の検出数は格段に増えることであろう。 これは短期的なデータインテグリティ対応である。

データインテグリティ違反が検出されれば、CAPA(是正処置・予防処置)を実施し、改善を図らなければならない。改善により再発防止や未然防止を確実なものにするのである。
これは中期的なデータインテグリティ対応である。
ただし、残念ながら改善を繰り返しても、エラーが0になることはない。少なからずデータインテグリティ違反は発生してしまうのである。ここで大切なことは、継続してデータインテグリティ対応を実施することである。
例えてみれば、乾いたタオルを絞るがごとく、継続的にデータインテグリティ違反をモニタリングし、改善を図らなければならないのである。
これが、GMP省令が要求する継続的な管理である。 データインテグリティ対応は終わりがなく、継続的な改善が望まれる。

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