FDA査察対応のコツ

先日、元FDA査察官で現在はコンサルタントのRobert C. Fish氏の講演を聞く機会があった。
彼の講演内容は、筆者がこれまでこのメルマガなどで記載していたことと非常に酷似しており、関心が深かった。

Fish氏によると、FDA査察官は、Life Science関連の学位を持っている人が多いという。
業界出身者も一部に入るらしい。
FDA査察官は査察官としての教育・訓練を受けている。

FDAのCompliance Programには、以下のような査察官への指示が記載されている。
・何を探すか
・どのように記録を評価するか
・どんなサンプルを集めるか
・ 不適合発見時、どんな行政措置を採るべきか?

Foreign Drug Inspection Compliance Programは、FDAのHPから入手可能で、以下を目的として作成されている。
・商業生産の準備状況について
・申請資料の信頼性について
・データインテグリティに関する調査について
・CP7356.022 Drug Manufacturing Inspection
近年FDAはデータインテグリティについて多くの問題を発見している。

FDA Form-484は、査察官がサンプルを持ち帰るときに発行する。製剤のサンプルを採取した時等に発行される。
偽造品が市中に出回っている場合に、科学分析・照合のために製薬会社から採取することもあるため、サンプルを取られたからと言って必ずしも警戒する必要はない。

FDA査察では、以下のような準備をするべきである。
1)    Compliance Programをおさらいし、実施されるであろう査察を想定する。
2)    申請書の中身を理解する。
3)    従業員の訓練を実施する。
4)    模擬査察を実施する。
5)    査察計画書を作成する。

従業員が心がけないといけないことは、以下のとおりである。

  • 何といっても査察準備として、整理整頓である。第一印象が大切だ。FDA査察は企業の敷地に入った時から始まる。秩序だっていると管理体制が行き届いていると査察官は感じる。Fish氏は草刈りの状態も見て、企業の管理の度合いを見たそうである。
  • すべての機器が清浄で校正されていることを保証すること。
  • 査察時においては、正直かつダイレクトに回答すること。「私にはわかりません」という回答は可能だ。その代わり知識があり、責任を持っている人を呼ぶこと。
  • プロ意識を持つこと
  • 礼儀正しく
  • 協力的であること。査察官も人間。人間の性質として、怒らせるとアグレッシブになってしまう。

従業員のしてはならないことは、以下のとおりである。

  • 余計な情報を与える。Yes / No QuestionにはYes / Noで答えること。自発的に情報を提供しないこと。
  • 想像で答える
  • 正確な回答を1回で提供すること。簡潔に、正しく答えること。回答が二転三転すると、査察官に疑念を抱かれてしまう。
  • 誤解を招くような情報を与える
  • 間違った情報を与える
  • 対立したり議論すること

査察計画書の作成は、以下のことに役立つ。

  • 期待を知る
  • 権利を知る
  • 混乱を避ける
  • FDA査察官の発見事項に対して的確に回答する

計画書の内容は以下のとおりである。

  • 査察官の出迎え、挨拶
  • 査察会場
  • 誰が査察を取り仕切るか?
  • 誰が記録をとるか?(1人以上が必要となり得る)
  • 誰が査察官に同行するか?
    (1人以上が必要となり得る⇒外国査察は2人以上のチーム(査察官&専門家)であることが多いため)
  • 回答者
  • 誰がバックヤードを取り仕切るか?
  • 誰がバックヤードにいるか?
  • 誰がリクエストされた文書を提出するか
  • 誰がWrap-up meeting、Close out meetingに出席するか?
  • 誰がFDAのObservationに対応するか?
  • 査察時の制限事項について(写真撮影を認めるか等)

バックヤードの目的
1)    FDAのリクエストを受ける
2)    FDAに提供する全ての文書を入手・レビュする(例:付箋が貼られていないかチェック!)
3)    提供資料が本当にFDAがリクエストしたものであることを確実にする
4)    提供資料のコピーを取る
5)    査察ファイル(Inspection File)を作成し、提供した資料をバインディングしていく

宣誓供述書(Affidavit)について

FDAに書面への署名を求められた場合、署名はしないこと。当該署名はaffidavitと呼ばれ、FDAが不適合等を発見した際に、その内容を認める場合に署名を求められる。署名した場合、行政措置時に証拠となってしまうため、署名しないほうが賢明である。

査察時
1)    FDAがサンプルを持ち帰る場合、持ち帰られたサンプルと同じものを持っておくこと
2)    ラベルを持ち帰られた場合、持ち帰られたラベルと同じものを残しておくこと
3)    査察官が持ち帰った全ての資料の写しを維持しておくこと
4)    毎日のwrap-up meetingの開催を依頼すること
close-out時のサプライズを避けるため。
査察中に指摘に対する是正を完了またはスタートさせるため(その場合でも483を受け取ることはあるが、annotationのステータスを『是正済み』にしてもらえる)
FDAに、不適合に対する是正がすでにあることを認識してもらうことが必要

Establishment Inspection Report(EIR)は、NAI(指摘なし)だった場合、査察終了から6週間~2か月で届く。2か月たっても届かなかった場合には確認すべきである。

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

Related post

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