IQの目的

IQ(Installation Qualification)は初期の適格性評価で、構造設備等が必要とされ期待されたサービス内容を持つことの確認をおこなうことである。日本語では、据付時適格性評価と呼ばれる。

PIC/S GMP Annex 15のIQ定義は下記の通りである。

据付時適格性評価(IQ)
施設、システム、装置の据付時や変更時に、承認された設計や製造業者の提案に適合することを検証し、文書化すること。

IQは、プロセスで使用する機器つまり構造設備が正しく据え付けられたか否かを確認する活動である。
事前にIQ計画書を作成しておき、チェックリスト等に従って下記を確認する。

  • 機器の設計概要(IQの配慮事項の列挙)
  • 据付条件
  • 校正、予防保全、洗浄スケジュール
  • 安全性概要
  • サプライヤの文書、印刷物、図面およびマニュアル
  • ソフトウェアの文書(CSVを含む)
  • スペアパーツのリスト
  • 環境条件

このようにIQでは、構造設備そのものが正しく据え付けられたかを確認すると同時に、サプライヤが作成した文書類をチェックしなければならない。
つまり、構造設備を運用していく中で実施しなければならない保守作業・校正等が文書により適切に記載されており問題がないことを確認しなければならない。
また、万が一構造設備を再設置しなければならないような際に、再度適切に据え付けられるかどうかを文書で確認しておかなければならない。
なお、上記の作業のうち、いつかはサプライヤの社内で行われることがある。
構造設備のユーザである製薬企業は、当該構造設備が使用に適したものかどうかという評価、チャレンジ、テスト等に責任を負う。

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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