Part11の改定の見通しについて

2008年4月7、8日にデンマークのコペンハーゲンで開催されたISPE主催のGAMP5発表セミナーでSion Wyn氏がPart11の改定の見通しについて講演しました。
Sion Wyn氏は、Conformity社のDirectorであり、GAMP5のEditorです。
現在FDAにPart11の改定のメンバーとしてアサインされており、Scope& Applicationの作成メンバーの一人でもあります。
講演要旨は以下の通りです。
われわれは現在でも発行したオリジナルの計画とパブリックコメントによって改定されたルールに沿って進めつつあるが、とりわけタスクチームの心配事と言えば、コメントをフォローすること、改定したガイダンスに従って改定したPart11規則を発表すること、さらにより改定したガイダンスを発行すること、そして明らかに新しいプリアンブル（前文）を完成させることである。
したがってまだ計画段階であるが、それがタスクチームとして達成すべきことである。
それがいつになるかという質問は答えにくい。
タスクチームにしてみれば、改定した規則の内容に満足しているが、いまだに当局における内部レビュプロセス中である。
FDAによって精査されるまではパブリックコメント募集のための発表ができないことになっている。
それはたいへん進行が遅く見えるが、それは特に最高評議会事務局での法的審査をうけなければならないからである。
それがまさに長い時間を要する理由である。
お伝えできることは、いまだ規則を改定し発表することに注力しているが、正直いつとはいえないということである。
もちろん今年中であると願っている。
それまでの間に何をするか、という問題には妥当かつ正当な答えがあると考えられる。
「Part 11 Scope and Application」のファイナルガイダンスは、2003年に出されたものの、昨今の電子記録と署名においての当局の位置づけを色濃く反映しており、いまだに極めて今日的な意味を帯びている。
したがってそのガイダンスを読めば、現行の規制では、ヨーロッパ勢が大変強い立場にあると推測される。
そしてまたGAMPのような業界ガイダンスによる電子的記録と署名に関する実践規範（good practice）を見ると、今日FDAが基本と考える患者の安全に関する完全性（Integrity）の適切なリスク管理を顕著に反映している。
常に「製品とプロセスの理解」に立ち戻ることが必要である。
一旦「製品とプロセスの理解」を得られれば、プロセス中の当該記録の役割とデータの完全性のインパクトが理解でき、それらの記録に対するリスクを抽出し、適切な管理を選択することが出来る。
それゆえ私は、どんな管理を常時適用するかまたは特定の環境においてのみ適用するかをはっきりと述べた規制要件（regulations）よりも、経営者たちそして明らかにサプライヤーが業界のことを考え、特にリスク認識において、理解に基づく適切な管理を選択するような規制を待ち望んでいる。
もう一つ混乱をきたす可能性のあることについて言っておくと、皆さんの中には最近連邦広報（federal register）でFDA のPart11に関してのコメント募集を見たかもしれない。これは再検討プロセスの一部ではなく、私は定期レビュと考えたい。
規制要件の経済的影響に関して、確実に規制の精査を要する要件がいくつかある。
ある期間が過ぎた後に、規制要件の経済的影響を再考するということである。
それは単に定期レビュだと考えられる。
この事実はすなわちPart11が経済的影響を保証する時が来たということである。
それで連邦広報でコメントを募集した。
新しい規制要件や変更があるということではなく、興奮する必要はない。
個人的には、改正された規制要件の発表の前に実施されるというのは、多少紛らわしいと考える。
たとえ連邦広報でそれを見たとしても、興奮しないこと。
それは新規制要件へのコメント要請とかそのたぐいのものではないのである。

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