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。
一方において、厚労省の審査課は、5/12に「新型コロナウイルス感染症の発生に伴う当面の適合性書面調査及びGCP 実地調査の実施要領に関する取扱いについて」と呼ばれる事務連絡を発出した。
この事務連絡の中には「治験依頼者等に対する適合性書面調査及び GCP 実地調査については、治験依頼者等より事前に提出された根拠資料を確認しクラウド等のシステムや Web 会議システム等を活用して遠隔的に根拠資料を確認する方法（リモート調査）により実施する場合があること。」との記載がある。
事務連絡には具体的な方法等は記載されていないが、おおよそ下記のとおりである。
・6月～8月は適合性調査は全てテレワークで実施している。
・状況を見て9月以降も延長する。
・適合性調査の2週間前までにクラウドストレージ（例：BOX等）に根拠資料（調査対象資料）を電子で（pdf化して）置く。
・調査官は事前に資料を自宅で精査しておいて、調査当日はWeb会議システム（WebEXまたはTeams等）を使用して調査官の自宅から質疑を行う。
これまでの書面調査に比べて、事前に関連する根拠資料をすべて開示する必要があることと、徹底的に資料を照査されるため、これまでみたいに抜き取りなどによる調査漏れの確率が低く、指摘を受ける可能性が高まることとなる。
つまりガラス張りの状態となる訳である。
したがって、New Normalにおけるテレワーク査察（遠隔査察）が主流となれば、日々記録を精査しておくなど、一層のコンプライアンスが求められることになる。
ここで、紙媒体の記録をスキャンしpdf化する際に問題がある。
ページを飛ばしてしまったり、用紙が傾いていたり、一部が折れてしまっているなどの不具合である。
完璧なスキャンデータを作成することにはいささかの困難が伴うのである。
当局としては多少の不備は許容するそうであるが、その場合は紙原本が保存されていることが条件となる。
したがって、今後は紙媒体を捨てない運用か、もともと電子で資料を作成する運用かに二極化されてくることになるだろう。
テレワークは、いずれその時代が来ることは以前から明白であった。しかしながらコロナ禍によって、一気に促進されたことになる。
このことは製薬・医療機器業界に限定したことではなく、食品業界をはじめ多くの業界でも実際に起きているパラダイムシフトである。
New Normalによって製薬・医療機器の業務プロセスがどのように変化するのか、また規制当局（FDA、PMDA等）の動向がどうなっているかなどは、引き続きこのメルマガで紹介していきたい。
また、資料がまとまった段階でセミナー等（もちろんNew Normalにおけるライブ配信セミナーである）を開催したいと考えている。
ご意見ご質問等は当社の「イーコンプライアンス公式LINE」から願いたい。（ID検索の場合：@ecompliance）
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