タイプライターイクスキューズについて

先日、ベルギーの製薬企業を監査する機会があった。多くのプロセスは適切に管理されており、特に問題は無いように思えた。

しかしながら、QCラボにおける試験成績書や試験報告書などを作成するために使用したExcelシートは、紙媒体に印刷後に削除しているとのことであった。
その根拠として、GAMP5の付属資料「S3_スプレッドシートを含むエンドユーザアプリケーション」 2.1章   スプレッドシートの一時的な使用において、Excelを削除して良い旨の記載がるためである。
これは間違っている。あくまでもExcelを電卓代わりに一時的に計算に使用した時の話なのである。

Part11が発行された際に米国において、製薬業界から以下のような主張があった。
『真の記録は紙の記録である。我々はコンピュータを単に記録を作成するために使っているに過ぎない。』 
上記の製薬企業の主張は、コンピュータをタイプライターとして使用しているのであって、Part11の対象ではないというものである。この説明をもじって「タイプライター・エクスキューズ」と呼ばれる。
FDAの見解は以下のとおりである。
『たとえば電子記録が作成されない場合のように、コンピュータが本当にタイプライターのように使用されている時のみ、Part 11は適用されない。』 

タイプライターとコンピュータシステムの大きな違いは、タイプライターは「One Time Printing」（つまり1度しか印刷できない）のに対して、コンピュータは何度でも同じ記録を印刷できることにある。その場合、1度目の印刷と2度目の印刷の間に電子記録の改ざんを行うことができ、印刷後バックデートでサインが可能となってしまうのである 。

Part11の座長であったPaul Motiseは、講演で以下のように述べた。
『プリントアウトを本質的に信頼することはできない。なぜならプリントアウトにはデータの再構築または生データから再現するために必要なメタデータ情報を含んでいないからである。』

FDAによると、電子記録（Excel）は、紙媒体に印刷したからと言って、削除しては削除してはならない。
その理由は、印刷した紙媒体ともとのExcelファイルの内容が一致していることを証明しなければならないためである。
Eｘｃelファイルを削除した場合、企業は不正を行っていないことを証明することはできなくなる。

規制当局は基本的には紙媒体に印刷した記録は信用しないため、電子記録を調査するのである。その目的は改ざんの発見である。

21 CFR Part 11の11.10 (c)にこういう記載がある。
「記録の保管期間を通じて記録の正確で容易な検索を可能とするような記録の保護」
つまり電子記録は保管が義務付けられている期間は廃棄することができない。またFDAの査察に対してすみやかに電子記録を検索し提示することができなければならないのである。
さらに11.10 (e)にはこういう記載がある。
「監査証跡は、少なくとも当該電子記録に要求される期間と同じ期間保管することが必要で、FDAのチェックとコピーができるようになっていなければならない。」
つまり電子記録に加えて、監査証跡もFDAが調査することがあるので、廃棄してはならないのである。

2015年3月に英国MHRAが発行した「MHRA GMP Data Integrity Definitions and Guidance for Industry March 2015」では、以下のように述べている。

監査証跡機能が備わったシステムとは、監査証跡機能が組み込まれたシステム、またはインターフェースがバリデートされている外付け監査証跡ソフトウェアが付加されたシステムである。GMPガイドのAnnex 11に記載された組込の監査証跡と同程度のことを紙ベース監査証跡によるハイブリッドシステムが達成できるのであれば、紙ベース監査証跡は許容される。この同等性を証明できない場合は、監査証跡付きのシステムに2017年末までにアップグレードする よう望まれている。

つまり、そもそもExcelをQCラボの試験結果や試験報告書、ひいて言えば出荷判定に使用することは望ましくない。
MHRAは2017年末までにLIMSなどのデータベースの導入を要求しているのである。


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