品質リスクマネジメントに関するガイドラインの改正（案）に対するパブリックコメントの募集

2022年2月28日より、品質リスクマネジメントに関するガイドラインの改正（案）に対するパブリックコメントの募集が開始された。締め切りは2022年4月1日である。
今般のガイドライン改正は2021年11月のICH Q9の改定を受けたものである。ICH Q9(R1)は2021年11月18日にステップ2となり、意見募集用に公表されていた。

筆者は、ICH Q9 「品質リスクマネジメントに関するガイドライン」は読み易い半面、内容が抽象的で具体性がなく、実際の適用のためにはさらなる具体的なガイドライン（例示など）が必要であると常々考えている。
実際に品質リスクマネジメントに関するガイドラインに準拠したSOP（つまり具体的な手順書）を作成しようとしても、非常に困難であることに気が付くはずである。

ICH Q9 「品質リスクマネジメントに関するガイドライン」はQualityに含まれているが、医薬品の開発段階も適用範囲に入っているので、注意が必要である。
開発段階では”品質リスクマネジメントは知識の蓄積の一部”としている。これにより、適切なリスクコントロールとは何かを技術移転の際に決定することが可能となる。

Q9(R1)においては「継続的改善」「医薬品品質システム」「管理できた状態」「不確実性」といった用語が新しく用いられた。
「継続的改善」「医薬品品質システム」「管理できた状態」はICH Q10と整合させたものであると思われる。
また「不確実性」は、ISO 9001におけるリスクの定義である。ICH Q9においては、ISO/IEC Guide 51に整合させて、リスクの定義を「危害の発生の確率とそれが顕在化した場合の重大性の組み合わせ」としている。ISO 9001におけるリスクの定義も引用している点が興味深いが、より抽象的になり、一般の人々には分かりづらいのではないかと思われる。
また今般の改正では、適用範囲には変更はないものの、医薬品の「安定供給の欠如」もリスクに加えられた。
つまり、品質に対するリスクには、製品の安定供給に影響があり、患者に危害が及ぶ可能性がある状況も含まれるのである。
さらに「サプライチェーン」におけるリスクも追加された。製造やサプライチェーンが多様化しても、製品の安定供給は実現可能であるが、サプライチェーンがますます複雑化することにより相互依存が発生し、サプライチェーンの頑健性に影響を及ぼす体系的な品質／製造リスクにつながる場合がありえるためである。

品質リスクマネジメントを実施する際には、適切な分野の専門家として、品質部門、事業開発、技術、規制、製造、営業・マーケティング、サプライチェーン、法務、統計、臨床等が含まれるべきであるとしている。

リスクの評価において、主観性が品質リスクマネジメントに持ち込まれる可能性があることを留意点としてあげている。

例えば、リスクの評価方法に対する意見が異なる場合などである。
リスクの定義に含まれる「発生確率」や「重大性」は、客観的なものではなく、主観的なものになってしまうことが多いためである。如何に科学的な（証拠に基づいた）評価を行うかが重要である。
リスクの評価の際に、会議室に専門家を集めて議論をしたとしよう。しかしながら、主観的な評価に終わってしまっては、時を変え、場所を変え、人を変えて再度リスク評価を実施した場合に、同じ結果になるとは限らないのである。
その結果、患者（被験者）にそのツケが回ってしまう危険性がある。
そのためには、知識の利用を確実に実施することが必要である旨、警鐘を鳴らしている。

4章の「一般的なリスクマネジメントプロセス」においては、従前の「リスク特定」が「ハザード特定」に訂正された。
筆者は、常々、セミナーなどで最初からリスクを特定することは不可能であり、ハザードを特定しなければならないと解説してきた。したがって、この訂正は喜ばしいことであると感じる。（セミナーで説明する必要がなくなった。）

5章の「リスクマネジメントの方法論」が充実した。
下記の2つの章が追加されている。
5.1 品質リスクマネジメントの形式
5.2 リスク に基づく意思決定（Risk-based Decision Making）

5.1 「品質リスクマネジメントの形式」において、「品質リスクマネジメント形式 は、二者択一的な概念すなわち、正規／非正規といったではない。」としている。
品質リスクマネジメントの形式とは、低から高までの範囲を持つ連続的な概念であると考えることができるためである。
また「品質リスクマネジメントプロセスに使う形式のレベルを下げるための妥当性の根拠として、リソース が制約されていることを用いるべきではない。」としている。それはその通りであろう。

6章の「企業及び規制当局の業務への品質リスクマネジメントの統合」も充実した。

添付資料Iでは、タイトルが従前の「リスクマネジメントの方法と手法」から「品質リスクマネジメントの方法と手法」に訂正された。
しかしながら、内容に関しては、一部追加があるものの、ほぼ変更はない。

添付資料IIでは、II.9 「サプライチェーン管理 の一環としての品質リスクマネジメント」が追加された。
・製造工程の変動と管理できた状態
・製造施設
・供給業者の管理監督と関係
などである。

品質リスクマネジメントQ9R1ダウンロード
「ICH-Q9-R1-品質リスクマネジメントに関するガイドラインの改正-（案）」-に関する御意見の募集についてダウンロード

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[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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