FDA査察対応のコツ(続編)

今回は、元FDA査察官で現在はコンサルタントのRobert C. Fish氏の講演用紙の続編である。
筆者はFDA査察対応を多く手掛けてきた。しかしながら、最近のFDA査察官は急激な増員と共にその質がかなり劣化していると感じる。
まともな指摘を出せない査察官も多く存在する。過去には、査察ルームには国際電話がかかるFAXの据え付けを要請された。その理由は、査察官がFDA本部に指摘するべきかどうかを判断を仰ぐためであった。現在では、電子メールで問い合せているようで あるが、筆者が観察している限り、あまり本質的な質問をしているようには思えない。
Robert C. Fish氏の経験やアドバイスは、新人FDA査察官にも有益なものであると思われる。

Data Integrityについて

1  FDAにおけるDIの歴史

1990年代から懸念-ジェネリック医薬品の不正問題(多くのジェネリック医薬品企業が刑事訴追を受けた)

2  FDA Statement

“A lack of data integrity often is Just Fraud” 
 十分なマネジメント、レビュがなされていない場合、申請書の信頼性が落ちる。

3    “Application Integrity Policy”

不正が疑われる場合、FDAはこのPolicyを適用する
・NDA審査を止める
・場合によっては、以降の審査を受け付けない

4  Data Integrityが求められる文書
 1)    Data 
 2)    Result
 3)    Written procedures
 4)    Records
 5)    Testing
 6)    Investigations

5    生データとは(21 CFR 58.3(k))

  • Raw data recorded
  • At  time obtained
  • By operator who obtained it
  • Directly entered
  • On current authorized form and records
  • Who did what and when (analysts sign/date those analysis or portions of analyses they performed

6     Foreign Drug Inspectional Compliance Program

  • 目的の内の一つが、DIの確認
  • PAIの場合、生データを査察⇒結果のコピーを確認⇒深堀して生データ確認⇒DI確認
  • Dataに対して重大な懸念がある場合、Office of Criminal Investigation (OCI)が来る。
    犯罪捜査の訓練を受けている人たち
    米国内においては武器携行が許可されている(日本には多分持ってこないと思う)

7  Warning Letters

  •  2013年、2014年において15~20のW/LがData Integrityに関するもの
  •  インド、中国の原薬工場に多い

8 Data Integrity不正企業の例

  • Abel Labs (2005)
    紙ベースの記録と電子記録が食い違っていた
    解析結果紙と電子で異なる
    FDAに見つからないよう、記録を破棄したり結果を破棄したりしていた
  • Leiner Health Products (2007)
  • Ranbaxy Labs (2008)

9 Warning Letter の内容の例

  • 記録の破棄
  • 監査証跡の不備
  • 試験室の記録に包括的なDataが含まれていない(生データ管理不備)
  • ユーザ名、パスワード、監査証跡

10 企業のすべきこと

  • Part11をチェック
  • Part11のガイダンスをチェック
  • 上記2つの遵守
  • 2人以上による入力、確認。特に重要なデータに関して。
  • データに不正・改ざんがないことの保証
  • Data Integrityに対する定期的なレビュ

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