FDAの海外査察の状況を保健福祉省(HHS)が批判

アメリカの保健福祉省(HHS)の監察総監室(Office of Inspector General, OIG)がFDAの医薬品に関する外国のfor cause査察に関する監査を行い、FDAの不備を批判する報告書を発出しました。

FDAの上位組織であるHHSがFDAを監査して、FDAに対して指摘を出したというものです。

OIGによるFDAの監査

OIGは、FDAが実施した以下の医薬品に関する外国のfor cause査察についてレビュし、監査を行いました。

  • 2016年1月1日~2017年3月31日に実施した64件の査察
  • 2018年1月1日~2019年3月31日に実施した68件の査察

監査の結果、OIGは以下の不備を発見しました。

  1. FDAは、外国のfor cause査察に関するポリシーと手順に必ずしも従っていなかった
  2. FDAは、すべての主任査察官(lead investigator)が査察を実施する前に必要なトレーニングを完了したことを裏付ける文書を提供できなかった

OIGによる、FDAへの改善推奨

OIGはFDAに対して6つのRecommendationを発出し、FDAは改善に取り組む旨を述べています。

  1. FDA should identify and implement additional ways to improve the timeliness of its foreign for-cause inspection process.
    (FDAは、外国のFor-cause査察プロセスのタイムリネスを改善するための追加の方法を特定し、実施する必要がある。)
  2. FDA should consider streamlining the process for writing and reviewing EIRs to minimize potential delays due to unexpected events.
    (FDAは、予期しないイベントによる潜在的な遅延を最小限に抑えるために、EIRの作成とレビューのプロセスを合理化することを検討する必要がある。)
  3. FDA should conduct an analysis of the workloards of indivisuals responsible for determining final classification, issuing warning letters, holding regulatory meetings, and address any potential issues identified by this analysis.
    (FDAは、査察の最終のクラシフィケーションの決定、Warning Letterの発行、レギュラトリーミーティングの開催を担当する個人の作業負荷の分析を実施し、この分析によって特定された潜在的な問題に対処する必要がある。)
  4. FDA should implement poliies and procedures to ensure that lead investigators assigned to inspections have completed the Level 1 Investigator Certification Process.
    (FDAは、査察にアサインされた主任査察官がレベル1の査察官認定プロセスを確実に完了するためのポリシーと手順を実施する必要がある。)
  5. FDA should ensure that supervisiors review investigators’ qualifications and document that they meet applicable training requirements when the investigator training records do not exist.
    (FDAは、監督者が査察官の資格を確認し、査察官のトレーニング記録が存在しない場合に、それらが該当するトレーニング要件を満たしていることを文書化することを保証する必要がある。)
  6. FDA should review the training records of the lead invstigators that were outside the scope of the audit to verify that the documentation supports either that the investigators completed the required training courses, Level 1 Perdformance Audit, and Level 1 Investigator Certification, of that the investigators are recommended “experened investigators” by supervisors and have completed training courses equivalent to the current required training courses.
    (FDAは、今回の監査の対象外であった主任査察官のトレーニング記録をレビューして、査察官が必要なトレーニングコース、レベル1パフォーマンス監査、およびレベル1査察官認定を完了しているか、査察官が監督者から「経験豊富な査察官」として推薦され、現在必要なトレーニングコースと同等のトレーニングコースを修了していることを文書がサポートしていることを確認する必要がある。)

HHSによるFDA監査報告書

報告書を閲覧したい方はこちらからどうぞ

HHSの指摘の1つである「主任査察官のトレーニング記録が提出できなかった」という、FDAが査察で頻繁に出す指摘をFDA自体が受けてしまったというのがなんとも皮肉ですね。
アメリカでは当局自体も監査対象となって是正がなされる点が良い仕組みとなっているように思います。

https://www.youtube.com/watch?v=zIHXobIP_vo

関連商品

[blogcard url=https://xn--2lwu4a.jp/qms-alex/ title=”QMS(手順書)ひな形 医薬品関連” ]

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