原薬GMPのガイドラインとCSV

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原薬GMPのガイドラインとCSVについて研究するページです。

＊万が一文中に解釈の間違い等がありましても、当社では責任をとりかねます。
　本文書の改訂は予告なく行われることがあります。

ICH Q7を受けて平成13年に発出された「原薬GMPのガイドライン」（平成13年11月2日、薬発第1200号）の5.4には、「コンピュータ化システム」の記載があり、次のとおりである。
5.40 GMPに関連するコンピュータ化システムについては、バリデーションを実施すること。なお、バリデーションの程度および適用範囲は、コンピュータ化されたアプリケーションの多様性、複雑性および重要性によるものである。
5.41 コンピュータのハードウェアおよびソフトウェアについては、適切な据付時適格性評価および運転時適格性評価により、課せられた業務の実行に適合していることを実証すること。
5.42 既に適格性が確認されている市販のソフトウェアについては、同じレベルの検査は必要でない。なお、既存のシステムについて、据付時にバリデーションが実施されていない場合には、適切な文書化された記録が入手できるならば、回顧的バリデーションにより検証する場合がある。
5.43 コンピュータ化システムについては、データに対する承認されていないアクセス又は変更を防止するために十分な管理を行うこと。また、データの脱落（例えば、システムの切断およびデータの不捕捉）を防止するための管理を行うこと。なお、データの変更については、全てのデータ変更、変更前のデータ、変更者、変更時期を記録すること。
5.44 コンピュータ化システムの運転および保守については、文書化した手順が用意されていること。
5.45 重要なデータを手動で入力した場合は、さらに入力の正確性の確認を行うこと。これは別の作業者又はシステム自体により行われる場合がある。
5.46 中間体・原薬の品質もしくは記録又は試験結果の信頼性に影響を与えるおそれのあるコンピュータ化システムに係る事故については、記録し、調査すること。
5.47 コンピュータ化システムに対する変更は、変更手順に従って行い、また、正式に承認し、文書化し、検査すること。システムのハードウェア、ソフトウェアおよびその他全ての重要な構成について行った修正および拡張を含む変更に係る記録を保管すること。これらの記録は最終システムが検証された状態に保守されていることを実証するものであること。
5.48 システムの破損又は故障が記録の永久的な消失を招く場合には、バックアップシステムを準備すること。また、データの保護を保証する対策を、全てのコンピュータ化システムについて設定すること。
5.49 データはコンピュータシステムに加え、別方法により記録される場合がある。

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