OQの目的

OQ(Operational Qualification)はプロセスが許容される結果を生み、限界値(ワーストケース)を確立していることのデモンストレーションである。
日本語では、運転時適格性評価と呼ばれる。

PIC/S GMP Annex 15のOQ定義は下記の通りである。

運転時適格性評価(OQ)
施設、システム、装置が、据付や変更に際して、予定した運転範囲を意図した通りに稼働することを検証し、文書化すること。

製造プロセスの様々なアクションレベルが製品特性に応じてわかり、コントロール状態を維持できる。これによりプロセスの頑健性につながる。
OQは以下の事項に配慮して実施する。

  • プロセスコントロール限界
  • ソフトウェアパラメータ
  • 原料の仕様
  • プロセス操作手順
  • マテリアルハンドリング要件
  • プロセス変更管理
  • トレーニング(OQが出来得るスキルを持たせる教育)
  • 短期の安定性と工程能力(プロセスキャパビリティ)
  • 故障モードの影響、アクションレベルとワーストケースの条件(故障モード影響解析:FMEA、故障ツリー解析:FTA
  • スクリーニング実験法のような統計的バリデート技術とプロセスを理想化する実験計画法を用いて鍵となるプロセスパラメータをこのフェーズで使用可能に出来る。

PIC/S GMP Annex 15では、OQは通常IQの後に実施されるが、装置の複雑さによっては、同時にIOQとして実施しても構わないとしている。
また一般にIOQはサプライヤに実施を委託することが可能である。 ただし、最終責任は製薬企業が持たなければならない。

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