Part11査察はなくなったのか？

FDAのホームページでは、ワーニングレターをすべて公開している。
21 CFR Part 11に関するワーニングレターは、2011年10月以降は見当たらない。
では、FDAはPart11査察をやめたのであろうか。
そうではない。実は、FDAのポリシーとして、発行当初からPart11ありきの査察は行わないこととしている。
つまり、あくまでも査察はプレディケートルール（GMPやQSRなど）に従って実施される。
また、ワーニングレターも、プレディケートルールを根拠に発行される。
最新のワーニングレターを分析していると、Part11とは明記がないものの、電子記録やExcelやバリデーションに関する指摘が多く見つかる。
査察の最終日に査察官が発行する483フォームは公開されないため、実際の指摘はかなり多く出されているものと推察できる。
昨今では、電子記録（コンピュータ）を使用せずに業務を行うことは考えられない。
しかしながら、電子記録には、紙記録にはない改ざんなどのリスクが伴う。
FDAは、査察を実施する際に、当該電子記録が信頼できるか（Integrity）を調査する。
これが、Part11査察に相当すると考えても良いだろう。
Part11は、1997年に発行されて以降、一度も改定されていない。
日進月歩のコンピュータの世界で、20年近くも前に作成されたルールが現在も通用する訳がない。
では、最新のFDAの期待と指導は、どうやって知ることができるのであろうか。
実は、Part11は改定されていないが、FDAの最新の期待や指導は、PIC/S GMP Annex 11 “Computerised Systems”に記載されている。
製薬企業や医療機器企業は、Annex11を参照し、最新のFDAの期待に応えなければならない。
Part11は、コンプライアンスコスト等の問題から、2004年以降はリスクベースで対応することとなった。
その際のリスクの評価は、当該電子記録が「患者の安全性」「電子記録の完全性」「製品の品質」にどの程度の影響を与えるかで判定する。
「患者の安全性」と「製品の品質」は、明確であると思うが、「電子記録の完全性」は少々わかりづらい。
「電子記録の完全性」とは監査証跡、タイムスタンプ、電子署名などのメタデータが完全に揃っていることを指す。
「電子記録の完全性」が損なわれると、査察官は当該電子記録を信頼することができず、査察を実施することができないのである。
紙面の制限から、解説を完全に行うことは難しい。

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