データインテグリティに対応した手順書とは

2021年8月1日から施行される改正GMP省令の第8条において、データインテグリティの確保が求められることとなった。
各手順書において「手順書等および記録の信頼性を継続的に確保」するよう作成することを明記している。
つまり、手順書等(製品標準書および手順書)および記録の信頼性確保のための仕組み作りが求められている訳だ。
また、同令第20条 第2項 文書および記録の管理では、

  1. 作成およ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。
  2. 作成された手順書等および記録が正確な内容であるよう、継続的に管理すること。
  3. 他の手順書等およ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。

といったように、「欠落がない」「正確」「不整合がない」ことを継続的に管理することを要求している。

データインテグリティの確保および品質リスクマネジメントへの対応は、既存の全部門、全プロセスが対象となる。
つまり、データインテグリティおよび品質リスクマネジメントを担当する専門組織を組織するわけではない。
既存の各手順書にデータインテグリティの確保のための要素を落とし込む必要がある。

また、当該文書及び記録の種類、内容等に応じて、その信頼性の確保に関して熟知している職員を「データインテグリティの確保責任者」として設置することも求めている。

手順書の改訂方法

では、いったいデータインテグリティを確保し、品質リスクマネジメントへ対応するための手順書改訂とは具体的にどういう内容になるのだろうか。

まず、データインテグリティを脅かすリスクには下記のものが考えられる。

  • MS-Excelを使用したプロセス(セキュリティリスク・監査証跡リスクなど)
  • データ入力(入力ミスなど)
  • 転記(転記ミスなど)
  • 計算(計算ミス、プログラムの不具合など)
  • 分析(分析プログラムの不具合など)
  • 保管(上書き・削除など)
  • 教育(思い込み、勘違い、日常的な違反など)
  • コンピュータシステムの時計の異常(正確なタイムスタンプ・監査証跡の欠如)

そこで、上記のようなリスクの発生が考えられるプロセス(手順書)において、下記のようなリスク低減策(データインテグリティの確保および品質リスクの発生頻度の低減手段)を盛り込んでいかなければならない。

  • ダブルチェック(入力ミスの発見)
  • コンピュータシステムによる自動入力(転記ミスの低減)
  • コンピュータシステムによる自動チェック(入力ミスの低減)
  • バリデーション(プログラム等の不具合の発見)
  • 電子フォルダーのセキュリティ(上書き・変更・削除等の回避)
  • 監査証跡のレビュ(不適切な者による入力・改ざんの発見)
  • 再教育・定期教育(思い込み・勘違い・日常的な違反の回避)

継続的な管理とは

多くの企業では、データインテグリティ違反が日常的にどの程度発生しているかを理解していないと思われる。
例えば、警察官を増員すると駐車違反の検挙件数が増え、またスピード違反の検挙件数が増えるだろう。
それらは、けっして駐車違反の数が実際に増えたわけでもなく、スピード違反の数が実際に増えた訳でもない。
また、MRを増員したり、教育を行えば、有害事象報告数が増加する。これも同様に有害事象の発生件数自体が増えたわけではない。
上記は、発見数が増えたに過ぎない。

下図を参照して頂きたい。データインテグリティの確保のためには、まずは要員の気付き(Awareness)が必要だ。そのためにはデータインテグリティに関する啓発活動(ポスターの掲示、リーフレットの配布、会議等での説明等)やデータインテグリティに関する教育訓練を実施しなければならないだろう。
また、どれだけデータインテグリティを確保するために各手順書を整備しても、また記録を精査してもデータインテグリティ違反はけっして0にはならない。
常にチェックを繰り返し、継続的にCAPAをまわし、改善(Action)を図る必要がある。 その後も、データインテグリティ違反の低減を続けるための継続的な作業(Maintenance)が必要である。


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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