21 CFR Part 11査察の動向と留意点

Part11は、もともと1990年代の初頭に電子署名(ペーパレスシステム)への認識始まり、産業界からの要請によって、FDAが指針を示すことから始まった。
しかしながらFDAが1994年8月に示したPart11のドラフトルールは、業界の期待したものとは大きく異なっており、FDAと業界との間で軋轢が生まれた。
Part11の条文解釈の難解さと要件遵守の困難さ(特にコンプライアンスコスト)から、業界はFDAに対し、幾度もPart11の緩和要請や取り下げ要求を行った。

Part11は、1997年3月20日に発表されて以来、一度も改定されていない。
しかしながら、日進月歩のコンピュータの世界にあって、17年も前に作成されたルールが現在も通用するものではない。
Part11を運用するうち、当初は電子署名に注目していたが、電子記録の方がより重要であることが認識された。その他、電子記録電子署名に関する新たな知見が見出され、FDAはPart11を改定しないまま、運用により期待や指導を変更した。
本来、期待や指導を変える場合には、Part11条文自体を改定するべきである。
しかしながら、業界との軋轢があり、Part11はこれまでに一度も改定することができなかった。
Part11は改定されていないため、最新のFDAの期待や指導は記載されていないが、実はEU GMP Annex 11(2011年6月30日から施行)に反映されている。
EU GMP Annex 11は、2013年1月1日からPIC/S GMP Annex 11にほぼそのまま採用された。

Part11や2003年9月に出されたScope and Applicationは、今でも有効である。

Part11不遵守を懸念し、紙媒体に印刷したものを“正”とする企業が多いが、本末転倒である。電子記録を作成した時点から、Part11は適用される。
Part11が施行された2000年前後は、Part11違反を恐れて、多くの製薬企業は電子ではなく、紙媒体で査察を受けようとした。
FDAの査察官は、検索性の良さなどから電子で調査を行いたいのであるが、企業がコンピュータシステムの存在を隠し、紙媒体で提示されるのはうんざりである。
査察官の方では、何とかコンピュータシステムが存在することを暴露させようとすることもある。

歴史と共にPart11に関する指摘は多きく変わってきた。
1997年にPart11が施行されてからは、主にコンピュータバリデーション/Excel/ネットワークセキュリティ/データインテグリティについて重点的に指摘が出された。
2003年9月にScope and Application Guidanceが出されて以降は、プレディケートルール(GMPやQSR)を基本に調査が行われるようになり、製薬企業ではOOS(Out Of Specification)、医療機器企業ではCAPAが重点的に調査されることになった。
2007年以降は、医療機器企業はCSVが中心となり、製薬企業ではデータインテグリティが中心となっている。

2007年3月14日にアテネで、「第31回 国際GMP会議」が開催された。
FDA事前承認査察オフィスチーフMr. Edwin Rivera Martinezによる「データインテグリティと不正 - 新たに迫りくる危機か?」
という表題のプレゼンテーションがあった。
ORA地方事務所によって10件の査察が割り当てられた。
10件のうち3件の査察において、非常に信頼性の疑わしいデータを明らかにした。
発覚した問題として:

  • 試験データバイアスのかかった改ざん
  • OOSとなったテスト結果を規格内であったとするために、クロマトグラフィックデータをカット&ペーストするといった、クロマトグラムの意図的なコンピュータの操作
  • 分析において、サンプルの重量および標準を改ざん
  • クロマトグラムの実行パラメータの変更
  • 正当化できる理由のないラボ分析担当者によるクロマトグラムの改ざんおよびOOSを規格の範囲内とするための計算の変更
  • 分析担当者が仕様の範囲内であるという分析評価結果を、バッチ製造記録に記載した

などが紹介された。

このことを受けて、FDAは以下の事項を実施することを表明した。

  1. データの完全性、データ改ざんおよび不正を明らかにするために査察官に特別な訓練を施す
  2. データの完全性および不正をより注視する
  3. 当局は、データ改ざんおよび不正行為に関する情報を、フォローアップすることをコミットする

一方で、業界は

  1. 適切なデータの受け渡しと報告のため、従業員を教育すること
  2. 申請および記録の作成時に報告されるデータの信頼性を確認すること
  3. 全社員がデータインテグリティに責任をもつことに重点を置くこと

2001年以降、Part11を根拠としたワーニングレターは発行されていない。
しかしながら、FDAプレディケートルールを根拠とした電子記録に関する指摘は多く出されている。
2010年7月8日に、FDAは、Part11査察を再開し、業界がどの程度Part11にコンプライアンスしているのかを調査している。ただし、現在では、ヒト用の医薬品についてのみ調査がされている。

FDA査察に対応するためには、最新のワーニングレターの傾向を分析しておく必要がある。

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