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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