リモート査察について

リモート査察について

2021年09月27日付のPTJにPMDAによる遠隔調査に関する記事が掲載された。
本記事のポイントは以下の通りだ。

  • PMDAはGMP調査に関しては引き続き実地調査を重視 ⇒不正の検知やデータインテグリティについて掘り下げた調査は困難であるため
  • 遠隔調査はあくまで試行的な取り組み
  • 渡航制限措置が緩和された国・地域から順に実地査察再開予定(国内製造所は2020年6月よりすでに再開済み)

また、PMDAでは遠隔調査は3つのパターンが想定されており、それぞれ、

  1. webカメラによりリアルタイムで製造現場を確認
  2. 事前に撮影した製造現場の動画を確認
  3. 特定の事項に的を絞った電話会議を行うといった手法を用いたうえで、文書および記録を確認する。

とのことである。

FDAによるリモート査察に関するガイダンス

2021年4月13日、FDAのCDER(Center for Drug Evaluation and Research)はCBER(Center for Biologics Evaluation)およびCVM(Research Center for Veterinary Medicine)の協力を得て、「Remote Interactive Evaluations of Drug Manufacturing Establishments」(COVID-19 公衆衛生緊急事態中の医薬品製造及び バイオリサーチモニタリング施設のリモートインタラクティブ評価業界向けガイダンス)を発行した。
本ガイダンスは、COVID-19パンデミック中のみ有効である。

医薬品企業にとって今後のFDA査察対応を考える上で一読する必要のあるガイダンスである。
リモートによるインタラクティブ評価の場合、その結論としてFDA Form483ではなく、FDAの所見(observations)を記載したリストが提供される。
当該Observationsに対して15営業日以内の回答が求められる。

本ガイダンスには、以下が示されている。

  • どのような場合にFDAはリモートによるインタラクティブ評価を実施を検討するのか
  • リモートによるインタラクティブ評価に用いる技術 – FDA Microsoft Teams – FDA Zoom for Government – FDA Adobe Connect
  • リモートによるインタラクティブ評価の実施
  • リモートによるインタラクティブ評価の実施におけるFDAの期待
  • リモートによるインタラクティブ評価後の対応 FDAのObservationsに対する回答期限等

なお、FDAはリモートインタラクティブ評価は「査察」ではないことを強調している(代替アプローチのうちの1つ)。

そのため、Form482(査察通知)及びForm483(査察オブザベーション)の発出はない。
ただし、ワーニングレターが発行されることがあるので注意が必要である。

リモートインタラクティブ評価として実施され得る事項

  • 文書、記録、およびその他の情報(電子システム)を要求および確認する。
  • ライブストリームや事前に録画されたビデオを使用して、施設、運用、データ、その他の情報を調べる。 
  • 施設の連絡先を通じて、質問や懸念に対処するための面接と会議をスケジュールする。
  • 施設の是正措置を評価する(たとえば、以前の査察または評価、または現在のリモートインタラクティブ評価への回答)。 一部の是正措置の妥当性を検証するため、または是正措置をリモートで評価するとリモートインタラクティブ評価の期間が不当に長くなる場合は、リモートインタラクティブ評価の代わりに査察が必要になる場合がある。

可能な場合はいつでも、観察と未解決の問題について施設に口頭で最新情報を提供する。
FDAは、リスクベースアプローチにより、リモートインタラクティブ評価を実施するかを決定する。
PAIの場合、

  1. 施設とのリモート対話が、申請審査中に特定されたリスクの評価に役立つ。 
  2. FDAが査察を必要とすると判断したデータインテグリティまたはその他の問題はないと判断した場合

リモートインタラクティブ評価を実施する。

サーベイランス査察の場合、リモートインタラクティブ評価のための施設の優先順位付けは査察のための順位付けと同様に行う。
FDAは、リモートのインタラクティブ評価を通じて収集された情報を使用して、将来の査察の範囲、深さ、およびタイミングを決定する。

フォローアップ/コンプライアンス査察の場合、対処されている特定の問題(たとえば、医薬品の品質管理、施設、または製造上の問題)に関連する操作、記録、およびその他の情報の調査を行う。
FDAは、旅行制限のために査察を実行できない場合や計画された査察を補足する場合など、リモートインタラクティブ評価が適切かどうかを判断する。 
リモートインタラクティブ評価の使用は、施設の性質と、割り当ての理由となる査察履歴やデータインテグリティに関する懸念を含むがこれらに限定されない。

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