Form FDA 483 とは

Form FDA 483 は、一般には公開されない。ただし情報公開法に基づき、有償で公開請求はできる。またWarning
Letter で483 の内容に言及することが多い。

ワーニング・レターvs.483
  • Form483は査察チーム単独から出される
  • ワーニング・レターは、高位のFDAの職員あるいは職員チームから出される
  • ワーニング・レターは、公式なレビュに基づき、重大な違反が存在するであろうことを示す
  • ワーニング・レターは、「規制の重大性」(“regulatory significance”)の違反に対し発行される
483及び回答
  • FDAの観点から、483フォームの目的は、問題領域を解決し、企業をコンプライアンスの状態にすること；483フォームは、コンプライアンスのアクションの公的な記録として利用される（ワーニング・レター他）
  • どの法律又は規制にも、企業が483に回答しなければならないとは書いてない
  • 483回答はFDA（方針）の現在の期待である。
  • 483回答は、企業が観察の記録リストを真摯にとり、コンプライアンス改善の意図をFDAへ説明する。
  • 483回答は、FDAの観察／非遵守の例証に対応するためのCAPAプランの重要な記録である。

Form FDA 483 を受取ったら

Form FDA 483 により指摘された内容に対し、15 営業日以内（必着）にレスポンスを送付しなければならない。
15 営業日以内に発送すれば良いのではなく、FDA に到着しなければならないことに注意が必要である。
Form FDA 483 による指摘への初回レスポンスは、極めて詳細である必要はない。
早急な回答により、企業がその期待を理解し、指摘を重大なことと受け止めているといった姿勢を表明することにもな
るため、できる限り早い目に送付することが必要である。
レスポンスは、査察を実施した査察官宛に送付するのではなく、FDA 本部に送付することに注意が必要である。つまり、
査察の現場を知らないFDA の上位組織が、レスポンスについて評価を行うことを理解しておかなければならない。
FDA がレスポンスを受取った場合、アクナレッジが返信される。
企業は、初回レスポンスで約束したとおり、その後の改善作業（例：SOP の改訂、スタッフの教育など）を実施した場
合、継続的にその進捗を報告しなければならない。
この継続的な報告は、FDA からクリアランスレターが送付されて来るまで実施しなければならない。
万が一、FDA がレスポンスや改善内容が不適切であると判断した場合、ワーニングレターに発展することもあり得る。

レスポンスの主要なステップ
  • 査察終了時、各観察を理解し、その背景の考察あるいは根本的理由を確認すること
  • FDA査察官／調査官が貴社に要望すること理解しなければならない
    • 記載事項が乏しい観察がある；観察が不明瞭な場合、FDA査察官が要望することは何か理解するのは貴社次第である。
  • 基本的な回答に含むもの
    • 観察の反復（例証）
    • 是正活動あるいはCAPA（アクション）
    • 期限（時期）
レスポンスの良い例
  • 達成可能で実現完了日の設定
  • フォーマット遵守：観察、回答／計画、完了日
  • 解答が完全で、簡潔で、整備されており、構成されている
  • 解答が、事実上正しい
  • 重大な観察には、徹底した回答
レスポンスに記載する事項

レスポンスには、以下の事項を記載すること。
1) オブザベーション
オブザベーションを再記載する。完了したものは太字にすると、読み易い。
2) CAPA または他のアクション（計画書）
問題を解決あるいは対処するために、オブザベーションについて企業が何を実行するか
3) 改善した証拠文書
改訂したSOP やその教育記録等を添付する。
日本語のままでは、FDA がレビュができないので、必ず英訳すること。英語以外で提出したことにより、ワー
ニングレターが発行された事例もある。

レスポンス（回答書）の書き方

回答書の作成にあたって設定される基本的な規則がある。
企業特有の状況に応じ、これらの規則の一部または全部が適用される。
例：行政体、顧客監査、保留のワーニング・レター等からなる非常に長いリスト

  1. 品質部門の上位者が回答を記載すること。
  2. 回答の写しを受領者に管理部門の上位者を含むこと。これは、企業の管理部門が問題の核心およびコミットメントを認知していることを示す。
  3. カバーレターまたは冒頭陳述を含むこと。監査者がプロフェッショナルであり、洞察または他の適切な見解を提供したことに謝辞を述べること。
  4. あなたが回答を書く相手は、監査者の管理部門－顧客同様、政府の監査団体であることを常に念頭に置いておくこと。その報告を読む人物がオブザベーションの背景、あるいはあなたの返答を理解しているとみなさないこと。
  5. 回答書にオブザベーション及びレファレンス・ナンバーを再度記載すること。特に、オブザベーションは回答に直結する。
  6. 可能なら、関連したコンプライアンと・システムを示すこと。このことは、あなたが管理者であり、オペレーションは受領可能なGMPパラメータ範囲内で機能していることを示す。
  7. アクション・アイテムのインプリメントに時間がかかりそうなら、GMPに遵守するため暫定措置を記載すること。現在からコンプライアント是正までの期間は、コンプライアンス外の状況にあると見なされるため、当該問題の是正アクションに6か月かかると単なる記載をしないこと。
  8. 是正措置がすでに講じられた場合、下記を示すこと。
    1. 措置が講じられた日
    2. 実施されたトレーニング（トレーニングのサインアップシートの写しを含む）
    3. パーチャス・オーダー、インストレーション作業等の写し
    4. 更新されたSOPの写し―何が変更されたか示すこと。
  9. オブザーブされた問題の再発を防ぐための補強措置を定義すること。読み手がこの事実を理解したと見なさないこと。
  10. システムの遵守のために何が拡張、強化、あるいは整備されたかを説明すること。
  11. トレーニングについて忘れないこと。テストの習熟を含むトレーニングを取り入れ、変更の実施に十分な時間をとること。
  12. 企業が是正措置の進行と効果をどのようにモニターしているかを記載すること。
  13. 問題が言及されているにかかわらず、問題はないと説明することは有用である。この回答を対策として毎回使用することは勧めないが、「本製品は常に所定の品質パラメータに適合している…」と概ね述べることは、重大なオブザベーションに対して有利である。
  14. 改正、改正、改正。直接監査に関わっていない他者に、回答についてレビュおよび回答をもらうこと。論点の明確化または強化を支援となる発言によって、回答の本質を見い出すかもしれない。

最初に回答を策定するとき、回答の形式を深く理解し、遵守にあたって実際に必要なものは何かをより良く理解するために、4段階の査察アプローチが有用である。この形式のアプローチには、

  1. オブザベーションの再述
  2. 根本的原因の定義
  3. 是正措置の提示
  4. 期限の表明

本アプローチにそのまま従えば、定義された根本的原因に対応することになるので、いかなる是正措置もシステマチックとなる。これはまた、実際の実行に必要なものに関してより多くの情報が企業にもたらされるので、期限を表明する助けともある。

レスポンスの例

  • 観察
  • 観察を再記載する。完了したものは太字にすると、読み易い。
  • CA, CAPAまたは他のアクション（計画書）
  • 問題を解決あるいは対処するために、観察について会社が何を実行するか；

非コンプライアンスを正す。

  • 完了日
  • 是正が適用された時期
例１

観察16　流動速度と圧力が設計範囲に対して調査されていないという点で、UF/DFのOQが不十分であった。

回答：UF/DF skidのOQプロトコルを作成し、それに従ってレビュし、QAの承認を得た。承認のプロトコルはバリデーションチームによって実行され、バリデーション報告書に加えられた。完全なOQバリエーション方向所がQAによってレビュされ、承認された。

完了日：OQプロトコルが鑑賞し、2009年12月21日に承認された。
OQバリデーションは2010年1月15日に完了した。

例２

観察12a(1)　Xygram IVの最終ろ過ステップは、プロセスの一環として　ウィルスろ過バリデーションまたはバイオバーデン管理記録を含むQAの事前承認を受けていなかった。

｛覚書を振り返って：査察官は、ウィルス除去バリデーションの署名フォームが好ましくないようだった。また本ステップの日常のバイオバーデンのフォームも好ましくないようだった。査察官は、QAの署名理由または署名箇所を、貴社が指摘できなかったとメモした。｝

回答：ウィルス除去バリデーションのQA承認の特定フォームは、QAによる明確な署名を含む形式に変更された。同様にSOPも、本署名の意味を含むものに修正された。
加えて、すべてのバリデーションに対し、すべてのQA承認は、QAの明確な署名を含む者に修正された。バイオバーデンのテストフォームは、QA承認の明確な署名を含むものに修正された。加えて、すべてのテストフォームは同様に修正された。

｛本回答がCAおよびPAを含むことを注記する｝

完了日：すべてのフォームおよびSOPは2009年12月20日までに修正／是正される。

以下、未整備

最善の措置

FDAフォーム483への回答

概要
  • 483回答の重要性
  • 新FDAプログラム：483レビュ及びワーニング・レター
  • いかに15日ガイドラインが貴社の回答に影響するか
  • 483に良い回答をするための重要な要素
  • CAPAの定義及び483回答への適用方法
  • cGMPの重大な違反のワーニング・レター例
レビュ後のFDAの通知

査察の回答*

  • FDA483観察の回答は、受領後15営業日以内に、詳細なレビュをいれること。
  • どのワーニング・レターも、483回答を認識し、楷書の是正措置についてのコメントがある。
  • 目的は、リソース使用の最適化、ワーニング・レターの即時発行、及び早急で自発的なコンプライアンスを促すことである。

*Fed Register Vol. 74, No. 153, Aug. 11,2009, p. 40211, FDA-2009-N-0335

483回答のタイミングはコミッショナーの一環

FDAに対するハンブルグ・イニシアチブ

  • 査察後のデッドライン。FDA査察の結果が重大な問題（コンプライアンスを大きく違反）の場合、企業は15日以内に、ワーニング・レターまたは強制措置実施前に回答すること。
  • ワーニング・レターの発行を急ぐこと。重大な公式文書のみが主席査察官(Chief Counsel)によりレビュされる。
  • 職員は、ローカル、国、国際を問わず、早急なアクションを取るために動き、公に注意を発し、長期間にわたる回答の準備をする。
  • 再査察または調査等、ワーニング・レターあるいはリコール後のフォローアップの実行の優先順位を決める。
  • FDAは、実行活動(enforcement action)前に多重のワーニング・レターを発行しない。悪質な違反には、即時行動を検討する。
  • 企業がワーニング・レター(通常再査察による)に記載されている違反を完全に是正したとFDAが判定した後、ワーニング・レターの「終了」(“close-out”)レターが発行されることがある。　
CAPAの定義
  • 是正措置(CA)では、特定の観察を是正したアクションを記載しなければならない。
  • 予防措置(PA)では、観察に見られる一連の懸念(any systemic concerns)に対処しなければならない。
  • 製品の品質におけるいかなるインパクトも、対処されなければならない。
  • 観察は単にCAあるいは長くてもCAPAと称されることがある。
  • 観察に同意できない場合がある。
  • 観察に同意できない場合は、データあるいは方針説明書(position paper)を提出する。無視してはならない。
483回答書：導入
  • 483回答はコンプライアンス状況から記載が望ましい。
  • 適用法及びFDA規制に遵守しているという企業のコミットメントを示すこと　
  • 企業が、cGMPコンプライアンス問題の是正について真剣であり、法律に従っていることを示すこと
重大な483観察
  • 重大な483観察に対し、ワーニング・レターが出される場合があり、以下のものがある。
  • 製品の影響の評価
  • 根本的原因を含むCAPA計画書の範囲の記載
  • 査察サマリー
  • 簡易なサポート文書
要点
  • 483回答の重要性
  • 新FDAプログラム：483レビュ及びワーニング・レター
  • いかに15日ガイドラインが貴社の回答に影響するか
  • 483に良い回答をするための重要な要素
  • CAPAの定義及び483回答への適用方法
  • 良い対応例
  • cGMPの重大な違反のワーニング・レター例

Related post

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