品質リスクマネジメントの要点

品質リスクマネジメントの要点

ICH Q9 「品質リスクマネジメントに関するガイドライン」が発出されたのは、2006年9月1日である。
つまりリスクの高い医薬品業界において、20世紀中はリスクマネジメントに関する標準やガイドラインがなかったのである。

食品業界においてはHACCP(ハセップ)と呼ばれるリスクマネジメント手法が1970年代からあった。
また医療機器業界においては 国際規格であるISO 14971が1990年代から存在した。

しばしば”クスリ”を逆に読めば”リスク”と言われる。
しかしながら、20世紀における医薬品の製造は、なんらかのガイドラインもなく人の経験と勘に頼っていたのである。
品質リスクマネジメントは、要員の経験と勘に頼るのではなく、科学的なリスクマネジメントを実施することが重要である。

品質リスクマネジメントにおいては、医薬品の「品質」における欠陥が患者に及ぼす「健康被害」を管理する。
医療機器におけるリスクマネジメントは、当該機器の故障が患者やユーザに直接影響を与えるのに対して、医薬品の製造におけるリスクは、何らかの失敗事象が医薬品の品質に結果をもたらし、欠陥を持った医薬品が患者に投薬された際に何らかの健康被害を及ぼすと言った、いわば間接的なリスクマネジメントである。
これが「リスクマネジメント」ではなく「品質リスクマネジメント」と呼ばれる所以である。

つまり、医療機器等におけるリスクマネジメントはダイレクト(直接的)であるのに対して、医薬品におけるリスクマネジメントは品質を介して患者に健康被害を与えると言った、インダイレクト(間接的)なリスクマネージメントである。
 
製造所における構造設備等の欠陥(故障、操作ミス等)が医薬品の品質に及ぼす影響を抽出するのである。
なお、ICH-Q9は、医薬品のライフサイクル全般(開発、製造、配送、査察及び承認申請/審査)をカバーしている。
つまり製薬企業のみならず規制当局も遵守義務があるのである。
また医薬品製造のみならず医薬品の開発もその適用範囲に含まれる。

品質リスクマネジメントは、医薬品品質システムと表裏一体をなし、ライフサイクルモデル(PDCA)を基本としなければならない。
つまり、品質リスクマネジメントは、決して医薬品品質システムの1プロセスではない。
また、品質リスクマネジメントを実施する専門部署を設置する訳ではない。
さらに、品質リスクマネジメントを実施するSOPを1冊作成する訳でもない。
規制対象のすべての既存部門のすべての既存SOPに品質リスクマネジメントの概念を入れ込まなければならないのである。

品質リスクマネジメントでは、医薬品製造における「医薬品の品質に欠陥を生じさせるリスク」を適切にマネジメント(管理)し、患者への健康被害を防止することが目的である。
例えば、
・構造設備の故障
・ヒューマンエラー
・ソフトウェアのバグ
・データインテグリティの欠陥
等である。

一方において、いたずらにコンプライアンスコストをはね上げ、結果的に患者負担を増大させないことに留意しなければならない。
リスクベースドアプローチをとること。

改正 GMP 省令においては、品質リスクマネジメント責任者を設置することとなった。(改正GMP省令 第3条の4 第2項)

構造設備における品質リスクマネジメントでは、故障、操作ミス(ヒューマンエラー)などの失敗事象に対して、主にFMEAを使用する。
設備導入時に実施すること。適格性評価(クオリフィケーション)におけるOQでFMEAを使用し、リスクコントロールを検証(リスクが十分に低減したことを確認)すること。
自動化装置(コンピュータ化システム)では、CSVを実施し品質リスクを低減すること。

関連商品

[blogcard url=”https://ecompliance.co.jp/SHOP/GMP-12.html” title=”【GMP省令対応】品質リスクマネジメント規程・手順書・様式” ]

[blogcard url=”https://ecompliance.co.jp/SHOP/EL-111.html” title=”【セミナービデオ】【医薬品】品質リスクマネジメントの具体的な実施方法セミナー 【品質リスクマネジメント手順書配布・実習付き】” ]

[blogcard url=”https://ecompliance.co.jp/SHOP/191120P.html” title=”【VOD】製薬企業における品質リスクマネジメントセミナー” ]

[blogcard url=”https://ecompliance.co.jp/SHOP/O091.html” title=”【VOD】【医薬品】品質リスクマネジメントの具体的な実施方法セミナー 【品質リスクマネジメント手順書配布・実習付き】” ]

[blogcard url=https://xn--2lwu4a.jp/qms-alex/ title=”QMS(手順書)ひな形 医薬品関連” ]

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