COVID-19におけるパンデミックは終息が見えない。私たちは当分の間withコロナとして過ごしていかなければならない。
世界では実質多くの経済活動が制限され、これまでのように容易に相手先へ赴いて対面による会議等を行うこともままならない。
しかしながら、患者の安全性の確保を考えた場合、医薬品等の査察を止める訳にはいかないだろう。
FDAは6/12に「COVID-19 and Beyond: Oversight of the FDA’s Foreign Drug Manufacturing Inspection Process」と呼ばれるCOVID-19下における外国企業の査察プロセスについてtestimonyを発行した。
コロナ禍における医薬品の査察に関するFDAのアプローチ等がまとまっている。
リモート査察におけるワーニングレター
昨今では、CDERから、リモートで実施する書面ベースの査察によるWarning Letterが発行されてきている。
例えばあるAPI製造企業は2020年4月16日にFDAから記録提供のリクエストを受けたが、いくつかの記録を提出できなかったようだ。
(あらかじめ定められた品質特性を備えたAPIを継続的に生産できるかどうかのプロセスバリデーションを実施しておらず、記録が提出できなかった等)
FDAは2020年12月3日、当該企業の製品に対して輸入制限(Import Ban)を課した。
また2021年4月13日にWarning Letterを発行している。 現在のところ、遠隔査察でGMP違反が見つかった場合、おおよそ1年後くらいにWarning Letterが発行されるようである。
関連 VOD配信セミナー
当社VOD配信セミナーは、視聴期間および回数制限はございません。
お好きな時間に、繰り返し何度でもご視聴いただけます。
・FDAリモート査察対応セミナー
セミナービデオはこちら。
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