CSV/Part11に関するワーニングレター

FDAによるCSV/Part11に関するワーニングレター

筆者は常々、コンピュータシステムのCSVやPart11について、過剰に対応するべきではないと主張してきた。
あるコンサルタントは「FDA査察等で査察官に見せるコンピュータシステムはすべてCSV/Part11対応をしていなければならない。」などと説明しているという。
例えば、QMSを説明するためのドキュメント管理システムや、苦情管理システム、CAPAシステムなどである。
筆者の経験から、ドキュメント管理システムや、苦情管理システム、CAPAシステムなどについて単にCSVを実施していないからと言って、指摘を受けたケースはない。
過去のFDAのワーニングレターを見ても同様である。
過去にCSVの不備がワーニングレター発行のトリガーになったケースもない。
多くの場合は、他の重要な要因(例:CAPA、苦情処理)によってワーニングレターが発行され、それらに引っ張られてCSVについても言及されているものである。
またはFDA Form 483における査察官の指摘に対して、回答(Response Letter)の内容が不適切(査察官の指摘を全く理解していないなど)であるためにワーニングレターが発行されているケースがほとんどである。

勘違いされては困るのは、筆者はCSV/Part11対応が不要であると言っている訳ではない。過剰な対応は不要であると主張しているのである。
過剰な対応は、いたずらにコンプライアンスコストを跳ね上げてしまうからである。
CSV/Part11対応はいわば品質管理/品質保証の傍流である。本来の製品の品質管理/品質保証に対して、リソースを多くかけるべきである。

CSVに関するワーニングレター

医療機器企業に対するCSVに関する指摘は、820.70(i)Automated processes(自動化工程)違反として出される。
指摘は、定文があり「Failure to adequately validate computer software used as part of production for its intended use according to an established protocol, as required by 21 CFR 820.70(i).」(21 CFR 820.70(i)で要求されているように、確立されたプロトコルに従って、製造の一部として使用されるコンピューターソフトウェアが意図された用途に対して適切にバリデートしていない。)と記載される。
ここで重要なのは「意図された用途」である。
多くの場合、査察において査察官にコンピュータシステムを使用して製造記録、苦情情報、CAPA管理などを説明する。
その際に、QMS(SOP)に記載されているルールや手順とコンピュータシステムの処理手順や機能が異なっている場合、上記の様な指摘が出されることがある。
指摘が出されるのは、ほとんどが自社で製作したソフトウェアである。(市販のソフトウェアで指摘が出されることはほとんどない。)
例えば、以下の事例があげられる。

  • 苦情管理システムにおいて苦情情報を承認した際に、データがロックされ修正が出来なくなっているが、SOPではフォローアップ情報に基づいて適宜最新情報に更新することとなっている。
  • 製造記録において検査の合格/不合格を担当者が自由に変更できる仕様になっている。またその際に何の警告も表示されない。

つまり明らかにソフトウェアの機能として不適切である場合である。
単にCSVを実施していなかったという理由のみで指摘され、ワーニングレターにまで発展しているケースはまず見当たらないのである。

Part11に関するワーニングレター

過去20年間において、Part11に関する指摘やワーニングレターは発行されていない
ワーニングレターで、電子記録や電子署名に関して言及されているものはあるが、ほとんどが文書管理や記録管理の不備であるといった指摘である。
つまり、たまたま電子で記録を作成/保存しているが、それら記録の管理が規制要件やQMS(SOP)に定められているルールや手順に沿っていないというものである。
また電子署名を使用しているが、QMS(SOP)に定められているルールや手順に沿って署名していないというものである。

ブラインドコンプライアンスについて

多くの医療機器企業は、査察における指摘を回避しようと躍起になっている。また規制要件があるからと言って、闇雲に遵守しようとする。いわゆるブラインドコンプライアンス状態である。
しかしである。本来の目的やゴールは査察合格ではない。製品の品質を保証し、患者の安全性、製品の有効性を担保することである。
FDAの査察では、本質的な指摘が出される。単にCSVを実施していないからとか、Part11対応をしていないからという理由だけでは指摘は出されない。
上述したように、コンピュータシステムの機能がSOP違反を犯していたり、明らかに不正が可能であったり、リスクを持っていると判断された場合に指摘となるのである。
本質的ではない指摘は、企業に余計なコンプライアンスコストの支出をさせ、ひいては製品価格に転嫁され、患者負担を押し上げてしまうからである。

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[blogcard url= https://ecompliance.co.jp/SHOP/O003.html title=”【VOD】現場目線で考える!すぐ活用出来る! コンピュータ化システムバリデーション(CSV)超入門2020″]

[blogcard url= https://ecompliance.co.jp/SHOP/L_MDCSV.html title=”【VOD】医療機器企業におけるCSV実践セミナー”]

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