PIC/S GMP Annex 11 コンピュータ化システム改定

PIC/S GMP Annex 11 コンピュータ化システム改定

2022年11月17日付でPIC/Sが「Concept Paper on the revision of EU-PIC/S GMP Annex 11 (Computerised Systems)」と題したNews Releaseを公表した。

PIC/S GMP Annex11の改定に関するコンセプトペーパーの公表に関するもだ。
なお、EU GMPのAnnex11も同時進行で改定作業が進められている。

改定の理由
2011年に公表された現行のAnnex11は多くの分野で十分なガイダンスを提供できていないという事実に鑑み、今回の改定が意図されている。

コンセプトペーパーでは、33の改定に関わる理由が概説されている。
例えば、以下のような事項が記載されている：

  • データインテグリティに関して、Annex11 には「data in motion」と「data at rest」(バックアップ、アーカイブ、廃棄) に関する要件を含むようにする。
  • 「デジタルトランスフォーメーション」および同様の新しい概念に対する規制上の期待を伴う文書の更新を検討する。
  • ICH Q9へのリファレンスを追加する。
    等

また、コンセプトペーパーではFDAが先日公表した「生産および品質システムのためのコンピュータソフトウェアアシュアランス（CSA）」のドラフトガイダンスのリリースについても触れ、
「当該ガイダンスとその影響は、GMP Annex 11 の潜在的な規制関連の側面に関して考慮される」
と述べている。

コンセプトペーパーに関するパブリックコメントの募集
当該コンセプトペーパーについて、2022年11月16日～2023年1月16日までパブリックコメントの募集がなされている。

コンセプトペーパーに記載された改訂のタイムライン（一部抜粋）
2022年12月：コンセプトペーパーに関するパブリックコメントの〆切
2024年12月：ドラフトガイダンスの発出、パブリックコメントの募集（3か月間）
2025年3月：ドラフトガイダンスに関するパブリックコメントの〆切
2026年6月：ECによるガイダンスの公表
2026年9月：PIC/Sによる受入

PIC/S news release↓
Concept Paper on the revision of EU-PIC/S GMP Annex 11 (Computerised Systems)
https://picscheme.org/en/news PIC/S GMP Annex11改定のコンセプトペーパー↓
https://picscheme.org/docview/4967

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