CSV実施はそんなに重要か

CSV実施はそんなに重要か

筆者のもとには、製薬企業、医療機器企業、ベンダー企業などから日々CSV(コンピュータ化システムバリデーション)実施についてのコンサルティング実施要請が来る。
多くの場合、規制当局の査察に備えたいからとか、顧客監査などで指摘を受けたくないからとか、単に規制要件は絶対に遵守しなければならないためという理由を述べられることが多い。
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。そもそもヘルスケア関連の規制要件の目的は、患者の安全性の担保、製品の品質の保証、製品の有効性の保証である。
査察のためにCSV文書を一式揃える(査察目的の文書化)などは本末転倒である。
一体どこを向いて仕事をしているのであろうか。

CSV実施の目的は査察対応ではない。目的と手段が逆転していることがしばしばである。
CSVは、規制の適用を受けるプロセスにコンピュータシステムを使用した際に課される。
しかしながら、コンピュータシステムは、プレディケートルール(GLP、GCP、GMP、GVP、GQP、GPSP等)の要求を満たすために、間接的に影響するものである。
直接患者の安全性、製品の品質、製品の有効性に影響する訳ではないため、CSV実施が最重要とは言えない。
CSVを実施するためには、企業はコンプライアンスコストを遣う。
しかしながら、企業が使ったコストは企業が自腹を切るのではなく、薬価や製品価格に転嫁される。
すなわち患者負担となるのである。
従って、いくらでもコンプライアンスコストを遣って良い訳ではない。
少し大げさなことを言うと、高額所得者しか救えない医療となってしまうのである。

規制要件だからとか、査察があるからとかといった理由で、やみくもにCSVを実施し、コンプライアンスコストを遣うべきではない。

まずは当該コンピュータシステムがどの程度、患者の安全性、製品の品質、製品の有効性に影響するのかを判断するべきである。
いわゆるリスクベースドアプローチである。

とりわけ、日本の企業はあらかじめ画一的な基準を設けたがる傾向にある。しかしながら、そもそもリスクベースドアプローチでは、基準というものはない。
各コンピュータシステムのバリデーションは、どの程度患者の安全性、製品の品質、製品の有効性に影響するのかによって都度基準を策定するべきなのである。

CSV実施に関する問合せがあった場合に、筆者は必ず、どのような製品であるのか、またどのビジネスエリア(非臨床試験、臨床試験、CMC、製造、製販後安全管理等)を尋ねることにしている。
その理由は、製品によってリスクが異なり、プロセスによってもリスクが異なるためである。
例えば、無菌製剤、抗がん剤、向精神薬、血液製剤、ワクチンなどの場合はリスクが高いだろう。
一方で胃腸薬、栄養剤などはリスクが低いだろう。
企業の要員は、規制当局の査察官に比べて、当該製品のプロである。
また各プロセスにおいてどのようなリスクが潜むか、どの程度リスクがあるかについても熟知しているはずである。
ぜひ、プロフェッショナルな活動を目指して頂きたい。
誰でもが出来るCSV手順書の作成や、様式の作成などはナンセンスである。

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