FDAの海外査察の状況

FDAの海外査察の状況

RAPSの記事によると、FDAは現在のところ海外査察を再開する予定はないようだ。

  • ミッションクリティカルなもの以外については、FDAは外国査察を再開する計画はない。
  • 査察ができない間は、引き続き記録の要求やMRAの活用などを行なっていく。
  • ただし、記録の要求などの手段はオンサイトの査察に代わるものではないことをFDAは強調している。

つまり、ミッションクリティカルと判断した場合は、海外査察を実施する可能性があるということである。

本邦におけるFDA査察

2021年8月25日の日本経済新聞に大津市にあるT社の医薬品製造所に対するWarning Letterが発出された記事が掲載された。

FDAは2021年2月15日~2月19日、22日、24日~25日にかけてT社の総合研究所の査察を実施した。
2019年~2020年の間に、T社の製造する無菌製剤で複数バッチにわたり重大な微粒子に関する欠陥があることが判明した。2021年2月に実施された査察は、当該問題に対するものと思われる。
コロナ禍において、海外査察が実施されたということは、本査察はミッションクリティカル査察であると考えられる。

W/Lは「21 CFR 211.192 製造記録のレビュ」違反で発出されている。
無菌製剤の微粒子に関する欠陥について適切に調査していなかったというものである。

211.192は「バッチまたは成分の原因不明の不一致および企画への不適合は、当該バッチが出荷されているかいなかに関わらず原因を十分調査すること」と規定している。
FDAは、T社が483への回答で提出した無菌製剤の微粒子欠陥に関する調査は不十分であるとしている。
そのために問題の根本的原因を特定し、タイムリーで効果的なCAPAを実施できていないと指摘した。

また、FDAは上記の問題についてData Integrityの観点からも指摘している。
査察において「浮遊微粒子測定記録の改ざん」およびその他のデータインテグリティ違反が見られたとのことである。

FDAは以下を指摘している。

  • 当該データインテグリティ違反により、製品の無菌性保証に疑義が生じること
  • 管理されていないテスト用ワークシートやラボ文書のレコンシリエーションのシステムの欠陥等によってT社の文書の信頼性が弱いこと
  • T社のQMSはT社が製造する医薬品の安全性、有効性、品質をサポートするためのデータの正確性および完全性を適切に保証していないこと

FDAはW/Lの中でT社に対し、FDAガイダンス文書「Data Integrity and Compliance with Drug CGMP」およびQ&Aを参照し、CGMPに準拠したデータインテグリティプラクティスを確立することを求めている。

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