本年8月1日から施行される改正GMP省令において、データインテグリティに関する要求が盛り込まれている。
改正GMP省令の第8条 手順書等の第2項には下記の要求がある。
2 製造業者等は、医薬品製品標準書及び手順書（以下この章において「手順書等」と総称する。）並びにこの章に規定する記録について、その信頼性を継続的に確保するため、第20条第2項各号に掲げる業務の方法に関する事項を、文書により定めなければならない。
この箇条では、手順書を作成する際に「文書及び記録の信頼性を確保」するよう要求している。
問題は用語の定義を含めて、改正GMP省令のどこにもデータインテグリティという用語が使用されておらず、不明瞭であるということである。
逐条解説（薬生監麻発0428第2号）には、下記の説明が記載されている。
（2）医薬品製品標準書及びGMP省令第8条第1項の手順書並びに同令第2章に規定する記録について、継続的に信頼性（いわゆるデータ・インテグリティ）を確保するため、同令第20条第2項各号の業務の方法に関する事項を文書により定めることを要するものであること。この場合の継続的とは、それらの文書及び記録の作成時から保管期間が満了するまでの期間にわたって継続するとの趣旨であること。
つまり逐条解説と読み比べることによって、第8条第2項にデータインテグリティの要求が記載されていることが分かる。
改正GMP省令の第20条 文書及び記録の管理の第2項には、下記の要求がある。
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。
このように本邦におけるデータインテグリティ要求は、
・手順書等並びに記録に欠落がないこと
・手順書等及び記録が正確な内容であること
・他の手順書等及び記録の内容との不整合がないこと
・手順書等及び記録の信頼性を確保すること
であることが分かる。
つまり、データのみではなく手順書といった文書に関しても“インテグリティ”が求められているのである。
データインテグリティを確保するために重要なこと
文書及び記録のインテグリティ確保のための仕組み作りが重要である。つまり、データインテグリティのための要素を各手順書に落とし込む必要があるのである。
データインテグリティは、全部門、全プロセスにおいて対象となる。そのため、データインテグリティを担当する専門組織を組織する訳ではない。
各手順書にデータインテグリティおよび品質リスクマネジメントの概念を挿入すること。
改正GMP省令の施行まで2ヶ月を切った。
読者各位の企業・組織において、全てのSOPを見直し、データインテグリティの要求事項を盛り込み、改訂・発行しなければならない。
また、SOP制定教育等において、各部門のプロセス毎にデータインテグリティに関する教育を実施しておくことも望まれる。
本邦にはデータインテグリティに関するガイドラインがない
FDAは1997年8月に発出した21 CFR Part 11 Electronic Records; Electronic Signatureにおいて、データインテグリティに関する要求を含めていた。ただし、当時は電子記録に限定されていた。
イギリスのMHRAは、2015年にGMPにおけるデータインテグリティに関するガイダンスを発行し、2018年にはGxP（GLP、GCPなど）まで適用範囲を広げたガイダンスを発行している。
WHOやPIC/Sにおいてもデータインテグリティに関するガイダンスが発行されている。
しかしながら、本邦においては、逐条解説において「いわゆるデータ・インテグリティを確保する」と記載されているのみで、具体的な指針等はない。
日米EUといった3極の1つを担う医薬品先進国としてはお粗末である。
用語の定義くらいは明確にして欲しいものである。
本邦においては、データインテグリティに関する具体的な要求事項については、海外のガイダンスを参照するしかない。
データインテグリティはけっして新しい概念ではない
しかしである。データインテグリティはけっして新しい概念ではないことにも注意しなければならない。
GLPやGMPでは、データインテグリティという用語は使用して来なかったが、これまでもデータの信頼性・一貫性・整合性を要求してきた。
つまり、実質として古くからデータインテグリティ要求は存在しており、いわば“常識”である。
そのため、FDAはデータインテグリティに関するガイダンスは発行せず、「Data Integrity and Compliance With Drug CGMP Questions and Answers Guidance for Industry」（FDA, December 2018）といったQ&A集を発行している。
関連商品
[blogcard url=”https://ecompliance.co.jp/SHOP/P139.html” title=”書籍 当局要求をふまえた データインテグリティ手順書作成の要点” content=”昨今，製薬業界ではデータインテグリティに関する関心が高まっている。
しかしながら，多くの製薬企業・医療機器企業で業務を行っている方々から，講演・書籍を執筆しているコンサルタントに至るまで，適切にデータインテグリティを理解している人は少ないと思われる。本書は，データインテグリティの真意を適確に解説し，多くの思い込みや勘違いを正すために執筆した。
筆者は，多くの場合，データインテグリティは，「不正」に焦点が当てられているように感じている。しかしながら，データインテグリティにおいて焦点を当てるべきは，不正のみではないのである。 ・・・中略・・・
データインテグリティの目的の1つとして，データが改ざんされていないことを保証することが挙げられる。上述の通り，患者の安全性にとって，故意によるデータの改ざんも入力ミスや転記ミスといった事故による改ざんも等しく問題となる。
多くのデータインテグリティに関するセミナーや書籍においては，悪意のある不正な改ざんに焦点が当たり過ぎている感がある。
しかしながら，不正による改ざんがそんなに多いわけではない。製薬企業として確立し対応しなければならないのは，不正よりも悪意のない改ざんである。 ・・・中略・・・
本書では，データインテグリティを正しく理解した上で，患者の安全性を担保できるよう，データインテグリティの要求事項を適切に反映したSOP の作成方法についてわかりやすく解説した。本書が製薬業界における安全性担保の一助になれば光栄である。”]
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