【7/1発効PIC/Sデータ・インテグリティ関連ガイドラインについて】ASTROM通信 223号

新型コロナの爆発的な感染拡大が気になりますが、いかがお過ごしですか？

今回は、2021年7月1日に発効したPIC/Sガイドライン、「GMP/GDP環境でのデータ管理とインテグリティに関する適正管理基準(PI 041-1)」について見ていきたいと思います。

このガイドラインは、過去にドラフト版が出ており、このメールマガジンでも2018年に取り上げたことがありますが、その内容から少し変わっているので、あらためて全文を見ていきたいと思います。
量が多いため、５回に分けて確認していきます。最後までお付き合いいただければ幸いです。

出典
Guidance on Data Integrity (picscheme.org)

PIC/S　GUIDANCE
GOOD PRACTICES FOR DATA MANAGEMENT AND INTEGRITY IN REGULATED GMP/GDP ENVIRONMENTS　

1章       文書の履歴
2021年6月1日　採択
2021年7月1日　発効

2章　序論
2.1　PIC/Sに参加する当局は定期的に、GMP及びGDPの原則の遵守のレベルを判断するためにAPI及び医薬品
　　 の製造業者及び販売業者の査察に取り組んでいる。これらの査察は、通常、オンサイトで実施される
　　 が、文書のエビデンスの評価はリモートもしくはオフサイトで行われるかもしれないが、リモートの
     データレビュのケースの制約が検討されるべきである

2.2　これらの査察プロセスの有効性は、査察官に提供されるエビデンスの正確性と、最終的には根本的な
     データのインテグリティにより判断される。査察官が提出されたエビデンスと記録の正確性と完全性
     について判断でき、信頼できることが、査察プロセスにとって重要である。

2.3　データ管理は、これに限らないが、データの方針、文書化、品質、セキュリティを含む、データの
     処理中に実行される全ての活動に及ぶ。データの正しい管理基準は、製造業者により生成され報告
     される全てのデータの品質に影響する。これらの基準は、データが帰属性、判読性、同時性、原本、
     正確性、完全性、一貫性、耐久性、利用可能性のあることを保証しなければならない。この文書の
     メインフォーカスは、GMP/GDPの期待に関わるが、例えば、原薬や医薬品の管理戦略や定められた
     仕様に基づく登録関係書類一式に含まれるデータのように、より広いデータの正しい管理基準の背景
     も考慮されるべきである。

2.4　データの適正管理基準は、医薬品品質システムの全ての要素にあてはまり、その原則は、電子システム
     によって生成されたデータにも、紙ベースのシステムで生成されたデータにも等しくあてはまる。

2.5　データ・インテグリティとは、”データが完全で一貫性があり、正確であり、信頼でき、確実である
　　 度合いであり、これらのデータの特性は、データのライフサイクルを通じて維持される“と定義される。
     医薬品が求められる品質であることを保証する医薬品品質システムにとって、データ・インテグリティ
     は、基本的なことである。貧弱なデータ・インテグリティの基準や脆弱性は、記録やエビデンスの品質
     をむしばみ、最終的には医薬品の品質をむしばむだろう。

2.6　データ管理とインテグリティの適正な管理に関する責任は、査察を受ける製造業または販売業者にある。
     彼らは全ての責任を負い、データ管理システムの潜在的な脆弱性に関する評価を行い、データ・インテ
     グリティが維持されることを確実にするための正しいデータガバナンス手順を設計して実施する義務を
     負う。

3章　目的
3.1　この文書は、下記の目的で書かれた：
3.1.1　正しいデータ管理に関するGMP/GDPの要件を解釈して査察を実施するため、査察団にガイドラインを
       提供すること
3.1.2　現在の業界の手順とグローバル化されたサプライチェインのもとで、PIC/SのGMPとGDPのガイドライン
       に記述された通りに、正当で完全で信頼できるというデータに関して存在する要件が実装されること
       を可能にするための、リスクベースの管理戦略に関する統合され理解を助けるガイドラインを提供
       すること
3.1.3　GMP/GDP査察の決められた計画と実施において、適切なデータ管理の効果的な実施を促進すること、
       調和したGMP/GDP査察のツールを提供し、データ・インテグリティの期待に関する査察の品質を保証
       すること

3.2　このガイドラインにより、備忘録などの査察団の資産と共に、査察官が査察時間の最適な利用と、査察中
     にデータ・インテグリティの要素の最適な評価を可能にするべきである。

3.3　このガイドラインは、適正なデータ管理基準に関するリスクベースの査察の計画を助けるべきである。

3.4　適正なデータ管理は、いつもGMP/GDPの一部と考えられてきた。それゆえ、このガイドラインは、定め
     られたことに追加で法的負荷を課すことを意図していない。むしろ、現在の業界のデータ管理手順に
      関し、存在するGMP/GDPの要件の解釈のガイドを提供することを意図している。

3.5　データ管理とインテグリティの原則は、紙ベース、コンピュータ化システム、紙とコンピュータの
     ハイブリッドシステムに等しく適用し、新しい概念や技術の開発や適用にいかなる制限も与えるべきで
     ない。ICH　Q10の原則により、このガイドラインは、継続的な改善を通じて、革新的な技術の適用を促進
     すべきである。

3.6　“医薬品品質システム”という表現は、品質目標を管理し達成するために使用される品質マネジメント
     システムを表現するために、この文書の中の大部分に使用される。“医薬品品質システム”は、GMPの
     規制により使用されるが、この文書の目的のために、GDPの規制で使用される”品質システム“という
     表現にも置き換え可能とみなされるべきである。

3.7　このガイドラインは法の下で義務的なものではないし、法的強制的のあるものでもない。医薬品及び原薬
     の製造業者・販売業者に対するデータ・インテグリティの要件に関する国の法律を制限したり取って
     代わったりすることを意図していない。データ・インテグリティの不備は、国の法律やPIC/S GMPまたは
     PIC/S GDPのガイドラインの関連する条項を参照されるべきである。

4章　範囲
4.1　ガイドラインは製造（GMP）・販売（GDP）の活動を行っている場所のオンサイト査察に適用するために
     文書化されてきた。このガイドラインの原則は、製品のライフサイクルの全てのステージにおいて適用
     可能である。ガイドラインは、査察中に考慮されるべき分野の非包括的なリストとしてみなされるべきで
     ある。

4.2　このガイドラインは、データガバナンスシステムの評価に限定されるだろうが、製造（GMP）・
     販売（GDP）の活動を行っているサイトのリモート（デスクトップ）査察にも適用する。オンサイトの
     評価には通常、データの検証と操作手順の遵守のエビデンスが求められる。

4.3　この文書は上述の範囲で書かれているが、ここに書かれている適正なデータ管理基準に関するたくさんの
     原則は、規制のある製薬及びヘルスケア産業のその他のエリアにも適用される。

4.4　このガイドラインは、法的な専門知識が必要とされる分野で、重大なデータ・インテグリティの脆弱性の
     発見を受けての “正当な理由がある”査察のための特別なアドバイスを提供することは意図していない。      

5章　データガバナンスシステム
5.1　データガバナンスとは？
5.1.1　データガバナンスとは、データ品質の保証を提供する手筈の骨子をいう。これらの手筈は、それが生成
       され、記録され、処理され、保持され、検索され、使用されたプロセス、フォーマットや技術に関わら
       ず、データのライフサイクルを通じて記録の帰属性、判読性、同時性、原本性、正確性、完全性、
       一貫性、耐久性、利用性を保証するだろう。データガバナンスシステムを実施するための法的な要件は
       存在しないかもしれないが、システムを制定することは、製造業者に、首尾一貫した方法でデータ・
       インテグリティのリスクマネジメント活動を定義し、優先度をつけ、情報をやりとりすることを可能に
       する。データガバナンスシステムの欠如は、管理手法の潜在的なギャップと共に、まとまりのない
       データ・インテグリティシステムを示すだろう。
5.1.2　データのライフサイクルは、いかにデータが、生成され、処理され、報告され、チェックされ、意思決定
       のために使用され、保持され、保管期間の終わりに最終的に廃棄されるかに注意を向ける。製品や
       プロセスに関するデータはライフサイクルの中で様々な境界を横断するかもしれない。これは、紙ベース
       とコンピュータ化システムの間、または、異なる組織の境界の間、即ち、内部（例：製造、QC、QA）と
       外部（例：サービスプロバイダまたは契約の委託者と受託者）でのデータ転送を含むかもしれない。

5.2　データガバナンスシステム
5.2.1　データガバナンスシステムは、PIC/S GDP/GMPに述べられた医薬品品質システムに不可欠なもので
       なければならない。データガバナンスシステムは、ライフサイクルを通じてデータの所有に注意を向け、
       意図的または意図しない変更の管理を含むデータ・インテグリティの原則に従うためにプロセスや
       システムの設計、運用、モニタリングや、情報の削除について検討すべきである。
5.2.2　データガバナンスシステムは、データ管理とインテグリティが効果的に管理されることを保証するため
       の特定の専門知識と共に適切に設計されたシステム、技術及びデータセキュリティ手段の使用の結合を
       頼りにしている。法人は、適切なリソースが利用可能であり、データガバナンスシステムの設計、開発、
       運用、モニタリングに適用され、システム・運用・データの重要性とリスクと釣り合っていることを
       保証するための対策を施すべきである。
5.2.3　データガバナンスシステムは、データのライフサイクルを通じて、品質リスクマネジメントの原則に
       ふさわしい管理を保証すべきである。これらの管理には以下のことがあるかもしれない。

　　　　●組織的

　　　　　〇手順　　例：記録の完了の指図と、完成した記録の保持
　　　　　〇作業員の教育と、データ生成及び承認の文書化された権限付与
　　　　　〇いかにデータが生成され、記録され、処理され、保持され、使用され、リスクや脆弱性が効果的に             　　管理されているかを考慮したデータガバナンスシステムの設計
　　　　　〇所定（例：日々、バッチ、または活動に関連のある）のデータ検証
　　　　　〇定期的な監督　　例：データガバナンスシステムの効果を検証するための自己点検手順
　　　　　〇データセキュリティ手順の専門知識を含むデータ管理とインテグリティの専門知識をもった職員
　　            の使用

　　　　●技術的

　　　　　〇コンピュータ化システムのバリデーション、適格性評価と管理
　　　　　〇自動化
　　　　　〇データ管理とインテグリティに関するより卓越した管理を行う技術の使用
5.2.4　効果的なデータガバナンスシステムは、経営陣による適切な組織の文化と行動の組み合わせ(6章)の
       必要性を含む有効なデータガバナンス手順に対する理解と関与や、経営陣のデータの重要性、データの
       リスク、データのライフサイクルの理解を示すだろう。障害を報告するための権限付与と改善の機会を
       保証する、組織内の全てのレベルの人員に対して期待されるコミュニケーションの証拠も存在すべきで
       ある。これは、データの偽造、改ざん、削除を誘発することを減らす。
5.2.5　データガバナンスに関する組織の配置は、医薬品品質システムの中で文書化され、定期的にレビュ
       されるべきである。

5.3　データガバナンスに対するリスクマネジメントアプローチ
5.3.1　経営陣は、ICH Q9の原則を使用し、データ・インテグリティの潜在的なリスクを最小化するための
       システムの実装と手順、未解決のリスクの特定することに責任を負う。契約の委託者は、供給者を
       保証するプログラムの一環として、受託者のデータマネジメント方針と管理戦略のレビュを実施すべき
       である。そのレビュの頻度は、リスクマネジメントの原則を使い（10章参照）、契約受託者により提供
       されるサービスの重要度に基づくべきである。
5.3.2　データガバナンスに割り当てられた努力とリソースは、製品品質のリスクに見合うべきであり、他の
       品質のリソースの要求ともバランスがとれていなければならない。GMP/GDPの原則に従って規制された
       全ての存在（これに限定されないが、製造業者、分析研究所、設備、輸入者及び卸売業者を含む）は、
       データの品質リスクに基づき満足できる管理状態を提供する、理的根拠の裏付けと共に完全に文書化
       されたシステムを設計し運用すべきである。
5.3.3　望ましい管理状態を達成するための長期的な方法を割り出す場合、リスクを軽減するために中間的な
       手段が実施され、効果がモニタされるべきである。中間的な手段またはリスクの優先順位付けが要求
       される場合、未解決のデータ・インテグリティのリスクが経営陣に伝えられ、レビュ状態におかれな
       ければならない。自動化・コンピュータ化システムから紙ベースのシステムに立ち戻っても、
       データガバナンスの必要性はなくならないだろう。そのような逆行のアプローチは、管理上の負担と
       データリスクを増やしやすく、3.5章に記載された継続的な改善の取り組みを阻む。
5.3.4　全てのデータや処理ステップが、製品品質や患者の安全性に同じ重要性を持つわけではない。
       リスクマネジメントは各データ/処理のステップの重要性を判断するために利用されるべきである。
       データガバナンスに対する以下のような効果的なリスクベースのアプローチが検討されるだろう：
　　　　・データの重要性（意思決定や製品品質への影響）
　　　　・データリスク（データの修正と削除の機会、製造業者の定期的レビュ・プロセスによる変更の
          　発見の可能性/視認性）
　　　　この情報から、リスクに比例した管理方法が実施されうる。このガイドラインのリスクマネジメント
        に言及した以降の章は、‘リスク’を、データリスクとデータの重要性の考えの組み合わせで呼ぶ。

5.4　データの重要性
5.4.1　判断に対してデータが与える影響は、データの重要性により異なり、判断に与えるデータの影響も
       変わるだろう。データの重要性に関する検討のポイントには、下記のことを含む。
　　　　・データが影響するのはどの判断か？
　　　　　例：出荷判定の判断をする時、重要な品質特性への一致を判断するデータは、通常、倉庫の
              清掃記録よりも大きな重要性を持つ。
　　　　・製品の品質や安全性に対するデータの影響は何か？
　　　　 例：経口錠剤に関する原薬の分析データは、一般的に錠剤の摩損度データより製品の品質や
             安全性への影響が大きい。

5.5　データのリスク
5.5.1　データ・インテグリティの要件は全てのGMP/GDPデータに関連する一方で、データの重要性の
       アセスメントは、組織がデータガバナンスの取り組みに優先度をつけることを手助けするだろう。
       この優先度付けのための論理的根拠は、品質リスクマネジメントの原則に従って文書化されるべき
       である。
5.5.2　データのリスクアセスメントは、無意識の変更、削除、喪失（偶然もセキュリティの不備による
       ものも）、再作成、意図的な改ざんに対するデータの脆弱性や、それらのアクションに対する発見の
       可能性を考慮すべきである。災害の場合には完全なデータの復帰を保証することも考慮すべきである。
       権限のない活動を防ぎ、視認性/検出性を増す管理方法は、リスクの軽減活動として使える。
5.5.3　データの不具合のリスクを増す要素の例は、無制限で主観的な結果をもたらす複雑で一貫性のない
       プロセスを含む。一貫性があり十分に定義され客観的であるシンプルなタスクは、リスクの軽減に
       つながる
5.5.4　リスクアセスメントは、ビジネスプロセス（例：製造、品質管理）に焦点を置き、データの流れと、
       データの生成や処理の方法を評価すべきで、ITシステムの機能や複雑さだけを考慮すべきでない。
       考慮すべき要素は下記のことを含む：
　　　　・プロセスの複雑さ（例：複数段階の工程、工程間やシステム間のデータ転送、複雑なデータ処理）
　　　　・データの生成・処理・保管・アーカイブの方法や、データの品質とインテグリティを保証する能力
　　　　・プロセスの一貫性（例：生物学的製剤の製造工程または分析試験は、低分子化学に比べ高い多様性
          　を示すかもしれない）
　　　　・自動/人の相互作用の度合い
　　　　・効果/結果の主観性（例：無制限のプロセス　対　十分に定義されたプロセス）
　　　　・電子的なシステムのデータと手動で記録されたイベントの比較結果（例：分析報告とローデータの
          　収集時間の明らかな相違）
　　　　・システムまたはソフトウエアに組み込まれたデータ・インテグリティの固有の管理
5.5.5　コンピュータ化システムに関し、ITシステムとの手動の連携は、リスクアセスメントのプロセスで
       検討されるべきである。特に、もしユーザがバリデートされたシステムから得たデータの報告に影響
       を与えることができ、システムバリデーションがこの文書の9章に述べられた基本的要件に取り組ま
       なければ、独立したコンピュータ化システムのバリデーションは、データ・インテグリティのリスク
       が低いという結論にならないかもしれない。人の介在を許さない、または、人の介在を最小に減らす、
       構成設定がされ、完全に自動化されバリデートされたプロセスは、データ・インテグリティのリスク
       を減らすものとして好ましい。技術的な理由で統合的な管理が不可能な場合、適切な手順の管理が
       され検証されているべきである。
5.5.6　管理とレビュの手順が効果的に望ましい結果をうんでいるかを判断するために、査察官により批判的
       思考の技術が用いられるべきである。データガバナンスの成熟度の指針は、アクションの優先順位付け
       をする組織的理解と、未解決のリスクの受容である。データ・インテグリティの不具合のリスクはない
       と信じる組織は、データライフサイクル内でもともと存在しているリスクの適切なアセスメントを
       しないだろう。だから、データのライフサイクルのアセスメントへのアプローチ、重要性、リスクは、
       詳細に調査されるべきである。これは、査察中に調査されうる潜在的な不具合の状態を示すかも
       しれない。

5.6　データガバナンスシステムのレビュ
5.6.1　データ・インテグリティの管理方法の効果は、自己点検（内部監査）またはその他の定期的レビュ・
      プロセスの一部として、定期的に評価されるべきである。これは、データライフサイクルを通して、
      管理が意図した通りに動作していることを保証するはずである。
5.6.2　所定のデータの適格性のチェック（例：日々、ロット、活動関連）に加え、自己点検活動は、次の
       ことを含む管理方法のより広範囲のレビュに拡張されるべきである：
       ・患者の保護という背景のもとで、適正なデータ管理基準に関する人員の理解の連続的なチェックと、
         品質や問題のオープンな報告に焦点が置かれた職場環境の維持の保証（例：適正なデータ管理基準
         と期待に基づく連続的な教育のレビュ）
       ・ローデータの入力に対し、報告されたデータ/結果の一貫性のレビュ
         これは、定期的なデータ検証チェック (リスクに基づき正当であることを証明する) に含まれない
         データや、所定のプロセスの継続的な効果を保証するために前に検証されたデータのサンプルを
         レビュできるかもしれない。
       ・GMP/GDPの活動に関連する情報が正確に報告されていることを保証するための、コンピュータ化
         システムのログ/監査証跡のリスクベースのサンプリング
　       これは、所定のコンピュータ化システムのデータが、手動または、報告された“例外報告“に
         よりレビュされる状況に関連する。
　　　　　※例外報告：予め“異常”と定められたデータまたは操作を特定し文書化する、バリデートされた
            検索ツールで、データのレビュ者による更なる注意や調査を求める
　　 ・データガバナンスの有効性の指標にもなるかもしれない品質システムの評価基準（即ち、傾向）
          のレビュ
5.6.3　データガバナンスシステムの効果的なレビュは、組織や技術的な管理と共に、会社の行動の相互作業
       の重要性に関する理解を示すだろう。データガバナンスシステムのレビュの結果は経営陣に伝えられ、
       未解決のデータ・インテグリティのリスクのアセスメントに用いられるべきである。

6章　良好なデータ・インテグリティの管理における組織の影響
6.1　全般
6.1.1　組織の行動に関する査察結果の引用を報告することは適切でないし可能ではないだろう。いかに行動が
       (i)データの修正、削除または改ざんの動機
       (ii)データ・インテグリティを保証するために設計された手順の管理の効果
       に影響を与えるかの理解は、さらに調査されるであろうリスクの有効な指標を査察官に与えることが
       できる。
6.1.2　査察官は組織の行動の文化の影響に敏感であるべきであり、適切な方法でガイドラインのこの章に
       書かれた原則を適用すべきである。効果的なクオリティ・カルチャとデータガバナンスは、場所毎
       の実施方法により異なるかもしれない。しかし、カルチャのアプローチがデータ・インテグリティ
       の懸念につながってきたことが明らかな場合、これらの懸念は修正のために査察官により組織に
       効果的かつ客観的に報告されるべきである。
6.1.3　文化により、組織の管理方法は下記のようになるかもしれない。
       ・オープンになる（組織の階層に部下が異議を唱え、システムまたは個人の不具合の完全な報告が
         ビジネス上の期待となる場合）
　 　・クローズドになる（報告の不具合や階層への挑戦が文化的に難しい場合）
6.1.4　オープンな文化での適切なデータガバナンスは、従業員の権限により医薬品品質システムを通じて
       問題を特定し報告するために促進されるかもしれない。クローズドな文化の中では、望ましくない
       情報の伝達の社会的なバリアにより、同等な管理レベルを達成するためにはより大きな管理の強化
       と第二のレビュが必要とされるかもしれない。この状況では、管理監督者への秘密の上申プロセス
       の有効性がより重要かもれしれない。またこれらの準備では、報告が経営陣により積極的に支持され
       奨励されることを明確に示すべきである。
6.1.5　データ・インテグリティに関する経営者の知識と理解の範囲は、組織のデータ・インテグリティの
       管理の成功に影響しうる。経営者は、データ・インテグリティの欠落を防ぎ、それらを検知するため
       に、自分たちの法的及び道徳的義務（即ち、義務と権力）を知らなければならない。経営者は、
       紙とコンピュータ化された（ハイブリッドと電子）ワークフローに関するデータ・インテグリティの
       リスクの視認性と理解を持つべきである。
6.1.6　データ・インテグリティの欠落は、不正と改ざんに限定されない。それらは、意図的でない可能性が
       あり、いつでもリスクをもたらしうる。データの信頼性を損なう可能性は、適切な管理を行う
       （5.3～5.5参照）ために、特定され理解されるべきリスクである。直接の管理は、通常、文書化された
       ポリシーと手順の形をとるが、従業員の行動への非直接的な影響（例えば、工程の能力を超えた生産
       に関する不当な圧力や誘発、データの改竄やよくない行動の正当化）も理解され、取り組まれるべき
       である。
6.1.7　データ・インテグリティの違反は、いつでも、どの従業員によっても起こりうる。従って、経営者は、
       問題の調査を可能にし、是正処置・予防処置を実施するために、問題の発見のために警戒を怠らず、
       もし発見した時は、データ・インテグリティの欠落の背景の理由を理解する必要がある。
6.1.8　データ・インテグリティの欠落には、患者の安全性への直接的な影響や、組織とその製品への信頼性
       の弱体化を含む、さまざまな利害関係者（患者、規制当局、顧客）への影響がある。これらの結果に
      関する従業員の認識と理解は、品質が優先事項であるという環境の育成に有効となりうる。
6.1.9　経営者は、データ・インテグリティの欠落を予防し、検知し、評価し、是正する管理を制定し、
       データ・インテグリティを保証するために、それらの管理を意図した通りに行うべきである。6.2章
       から6.7章は、経営者がデータ・インテグリティを成功させるために取り組むべき重要項目を述べて
       いる。
6.1.10　経営陣は、適切な組織のカルチャと行動(6章)と、データの重要性・データのリスク・データの
        ライフサイクルの理解の組み合わせの必要性を含む、データガバナンスの適切なレベルの理解と
        効果的な手順への関与をすべきである。不具合や改善の機会を報告する権限付与を保守する方法で、
        組織内の全てのレベルの職員に対して期待されるコミュニケーションおのエビデンスも存在すべき
        である。これは、データの意図的な改竄、変更、削除の誘発を減らすだろう。

6.2　組織の価値観、品質、職員の日頃の行いと道徳に関するポリシー
6.2.1　職員の行動、品質への責任、組織の価値観と道徳に対する適切な期待は、組織を通じてはっきりと伝え
       られるべきであり、ポリシーは、適切なクオリティ・カルチャの導入と維持を支えるために存在して
       いなければならない。ポリシーは、経営者の品質に対する信条を反映し、全ての個人が患者の安全と
       製品の品質を保証するために責任を負うという信頼の環境を作る目的で書かれるべきである。
6.2.2　経営者は、職員に、データの品質を保証し、製品の品質の保証と患者の安全性を守るための行動を実施
       する役割の重要性を気づかせなければならない。
6.2.3　行動規約のポリシーは、公正といった道徳的行動の期待を明確に定義すべきである。これは、全ての
       職員に伝達され、十分に理解されなければならない。伝達は、要求事項を知ることだけに限定される
       べきではなく、なぜそれらが制定され、要求事項を満たすことを失敗した場合の結果を知るべきである。
6.2.4　データの改ざんの検討、許可されていない変更、データの破壊、その他のデータの品質を傷つける行為
       のように望まれない行動は、迅速に対処されるべきである。望まれない行動や態度の例は、会社の
       行動規約に文書化されるべきである。望まれない行動に対してとられる措置は文書化されるべきである。
       しかし、とられる行動（懲戒処分など）を保証するための配慮がされるべきで、みつかったデータ・
       インテグリティの問題のその後の調査を妨げてはならない。例えば、厳しい懲罰は、調査に対し、他の
       職員が値の情報を明らかにすることを妨げるかもしれない。
6.2.5  適正なデータ管理とインテグリティの適正な手順を遵守する行動の表示は積極的に促進され、適切に
       評価されるべきである。
6.2.6　通報者/職員が影響を受けることなく、行動規約に違反の可能性のある出来事を、職員が経営陣宛に
       届けることを促進する会社のポリシーと手順により支持された秘密の上申プログラムがあるべきである。
       経営陣による行動規約への違反の可能性が認識され、そのケースのための適切な報告メカニズムが
       利用可能であるべきである。
6.2.7  可能であれば、経営者は最初の段階から、会社のポリシーの目的や要件を支持するよう、管理を行う
       システムを実装すべきである。

6.3　クオリティ・カルチャ
6.3.1　経営者は、たとえば、職員がデータの信頼性の潜在的な問題を含む、不具合やミスを自由に伝えることを
       促し、是正処置・予防処置をとることができる、透明でオープンな職場環境（すなわち品質環境）を創る
       つもりでなければならない。組織の報告構造は、全てのレベルの職員間での情報の流れを許可しなければ
       ならない。
6.3.2　クオリティ・カルチャは、経営者、チームリーダ、品質部門の職員、及び全ての職員によって一貫して
       示される価値観、信念、思考、行動の蓄積で、データの品質とインテグリティを保証するための文化を
       創造することに寄与する。
6.3.3　経営者はクオリティ・カルチャを以下のことにより育成できる：
　　　・期待の気づきと理解を確実にすること（例：価値観や道徳の規則や行動規約）
　　　・経営者は、例を使って導きながら、彼らに期待する行動を示すべきである
　　　・特に任せられた活動について、行動と判断が説明可能であること
　　　・ビジネスの実施の中に連続的かつ積極的に含まれていること
　　　・職員に与えるプレッシャーの限度を考慮し、現実的な期待が設定すること
　　　・経営上の要求や期待を満たすために適切な技術的リソース及び職員のリソースを割り当てること
　　　・データ・インテグリティを保証する正しい文化的な態度を促進する公平な実施と、当然の結果や褒章
　　　・学んだ知識が組織に適用されるために、規制動向を意識すること

6.4　医薬品品質システムの近代化
6.4.1　現在の医薬品品質システムに、近代的な品質リスクマネジメントの原則と、適正なデータ管理基準を
       適用することは、複雑なデータの生成を伴う課題に対応するためにシステムを近代化させるのに役立つ。
6.4.2　会社の医薬品品質システムは、データ・インテグリティの欠如につながるかもしれないシステムや
       プロセスの弱点を防ぎ、検知し、是正することができるべきである。会社は、データのライフサイクル
       を知り、生成されたデータが有効で完全で信頼できるようにするための適切な管理と手順を組み込ま
       なければならない。特にそのような管理と手順の変更は、以下の分野にありうるだろう。
      ・品質リスクマネジメント
      ・調査プログラム
      ・データのレビュ手順(9章)
      ・コンピュータ化システムのバリデーション
      ・ITのインフラストラクチャ、サービス、セキュリティ（物理的及び仮想の）
      ・供給者/委託者の管理
      ・データガバナンスとデータガバナンスのSOPへの会社のアプローチを含む教育プログラム
      ・分散的/クラウドベースのデータ保管、処理、転送活動を含む、完成された記録の保管、処理、転送、
　　　　検索
　　・データ・インテグリティの期待を満たすために設計された要件を取り入れたGMP/GDPの重要な装置や
　　　　ITインフラストラクチャの購入の適切な管理
　　・データの品質とインテグリティを含めた自己点検プログラム
　　・業績評価指標（品質測定）と、経営陣への報告

6.5　業績評価指標（品質測定を含む）の定期的なマネジメントレビュ
6.5.1　迅速な方法で重大な問題が特定され、上申され、対処されるような、データ・インテグリティ関連の
　　　 事項を含む定期的な業績評価指標のマネジメントレビュがあるべきである。重要業績評価指標（KPI）
       が選択される場合は、うっかりデータ・インテグリティの優先順位が低いカルチャにならないよう、
       注意が払われるべきである。
6.5.2　経営陣がいかなる問題にも気づき、それに対処するためのリソースを割り当てることが出来るよう、
       品質部門の長は直接リスクを伝えることができるための経営陣との直接のアクセス手段を持っている
       べきである。
6.5.3　経営者は、定期的にシステムと管理の効果を検証する独立した専門家を迎えてもよい。

6.6　リソースの割り当て
6.6.1　データの生成や記録の保管に責任を負う者の業務負荷とプレッシャーが、エラーやデータ・インテ
       グリティを意図的に傷つける機会を増やす可能性がないように、経営者は、適切なデータ・インテ
       グリティ管理を支え、維持するために、適切なリソースを割り当てなければならない。
6.6.2　品質、管理監督、ITサポート、調査の実施、教育プログラムの管理のために、組織の運営に見合う
       十分な職員がいるべきである。
6.6.3　問題になっているデータの重要性に基づき、必要性に合った装置、ソフトウエア及びハードウエア
       を購入するための準備がされているべきである。会社は、ALCOA+の原則の遵守を強化し、データの
       品質とインテグリティの弱点を和らげる技術的なソリューションを実装しなければならない。
6.6.4　職員は、正しい文書化手順（GdocPs）の重要性を考慮し、適切に分離された自身固有の職務のために、
       適格性があり教育されていなければならない。例えば、電子データのレビュのような重要な手順に
       関する教育の効果のエビデンスがあるべきである。適正なデータ管理手順の概念は、ITやエンジニア
       リングの分野を含むGMP/GDPの役割を果たす全ての機能的な部門に適用する。
6.6.5　データの品質とインテグリティは、全ての人になじみが深いはずだが、様々なレベル
       （SME(主題専門家)、管理者、チームリーダ）から集めたデータ品質の専門家が、調査を指揮／サポート
       し、システムのギャップを特定し、改善の推進するために一緒に働くよう招集してもよい。
6.6.6　データ管理者のような正しいデータ管理に関する組織の新しい役割の導入が検討されてもよい。

6.7　内部的にみつかったデータ・インテグリティの問題への取り組み
6.7.1　データ・インテグリティの欠落が見つかった場合、それらは、医薬品品質システムに従って逸脱として
       取り扱われるべきである。問題の範囲と根本原因を特定すること、それから、その全ての範囲で問題を
       是正し、予防手段が実施されることが重要である。これには、システム内の弱点を特定するための
       ギャップのアセスメントを含む、追加の専門家の助言や視点のための第三者の使用も含むかもしれない。
6.7.2　患者の安全と製品への影響を検討する際、導き出されたいかなる結論も、合理的で科学的なエビデンス
       によって裏付けられなければならない。
6.7.3　是正は、製品の回収、顧客への通知、規制当局への報告が含まれるかもしれない。是正と是正処置計画
       とその実施は記録されモニタされなければならない。
6.7.4　更なるガイドラインは、このガイドラインの12章にある。

まとめ

いかがでしたでしょうか。

長いのでげっそりされているかと思いますが、まずは、データの適正管理基準は、2.4章にある通り、電子で生成されたデータにも、紙ベースで生成されたデータにも等しく適用されるということをしっかり認識しておく必要があります。

データ・インテグリティという話になると、紙の記録には適用されないと思われる方もいらっしゃいますが、紙ベースのデータにも適用されるということが明記されているので、注意が必要です。

また、データ・インテグリティは、現場レベルで注意しましょうねという類のものではないということが以下の章に書かれています。
6.2　組織の価値観、品質、職員の日頃の行いと道徳に関するポリシー
6.3　クオリティ・カルチャ
価値観や道徳、カルチャという文言には、正直、そこまでしないといけないのか？と引っかかる部分もあるのですが、昨今発生しているさまざまな問題を考えると、組織の本質から見直していく必要があるのかもしれないという気もします。

　

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