改正GMP省令の問題点

改正GMP省令の問題点

今回は改正GMP省令に関する問題点を筆者の目線から論じたい。

改正が遅い

前回の改正からすでに16年も経ってしまった。
2013年にGMP施行通知が改正され、PIC/S基準が導入されていた。今回のGMP省令改正は、GMP施行通知に盛り込まれていた内容を含んだものとなっている。
そもそも本邦における規制要件は後追いである。課長通知や施行通知で運用が浸透した後に省令を改正する。つまり省令の要求事項は施行日以降は完全に遵守義務があるわけだ。
一方で欧米の規制要件は期待と指導を盛り込んでいる。つまり、施行日に遵守できていない場合、指導を行い、浸透した後に指摘をするといった形式である。
そもそも本邦において、何を遵守すべきか、どこまでが規制要件かが不明瞭であると感じている。
・GMP省令
・GMP施行通知
・逐条解説（薬生監麻発0428第2号）
・その他、課長通知
・事例集・Q&A集
・海外のガイドライン等
例えば、GMP省令本文に要求はないが、逐条解説に記載されている要求事項なども多い。
またPIC/S GMP Annex15やデータインテグリティなどのように海外のガイドラインを参照することを示唆しているものも少なくない。

施行日までの期間が短い

本改正はいわば大改正である。にもかかわらず施行日（2021年8月1日）までの期間が短い。（約4ヶ月間）
なお、同じく本年改正されたQMS省令の場合は、移行期間は3年間である。
すでに本メルマガで解説した通り、品質リスクマネジメントやデータインテグリティに関する要求事項は、ほぼすべての既存の手順書に盛り込まなければならない。
また、医薬品品質システムを構築し、品質マニュアルを作成しなければならない。
これらは非常に労力と時間がかかる作業である。
事例集の発行を待っている訳にはいかない。

明確さに欠ける。読みにくい。理解しにくい。

本邦においては、片手に省令を持ち、別の手で逐条解説をもって比較しながら読まなければならない。
逐条解説を読まなければ意味が分からない条文が少なからずあるためである。
例えば、省令本文には「品質マニュアル」の作成を明確化（明記）していない。しかしながら、逐条解説には「品質マニュアル」の記載がある。
品質マニュアルは品質システムの基本であり、品質システムで最上位の文書である。なぜ省令本文で作成を要求していないのであろうか。
また、逐条解説において、品質方針と品質マニュアルを混同しているような記載がある。ISO 9001やISO 13485などでは、品質方針は経営者が定義し、その中に品質方針を盛り込むのことになっている。
また、データインテグリティという用語も省令本文には記載がなく、逐条解説で記載されている。
また、本邦ではデータインテグリティに関するガイダンスが発行されていない。FDAやMHRAなど諸外国のデータインテグリティに関するガイドラインを参照するしかない。 さらに、マネジメントレビュの具体的な要求がない。マネジメントレビュは医薬品品質システムの中核である。（下図参照）


省令本文にマネジメントレビュという用語が使用されておらず、また逐条解説においてもマネジメントレビュの具体的な実施方法（要求事項）が解説されていない。
・誰が報告するのか（インプットを作成するのか）
・誰が参加しなければならないのか
・手順書の作成は不要か（要求されている17手順書には含まれていない）

基準ではない

省令タイトルが「医薬品及び医薬部外品の製造管理及び品質管理の基準に関する省令」のままである。
しかしながら、本省令に基準は示されていない。
グローバルの規制要件はもはや基準は示さず、製造業者がリスクベースで自ら基準を決めるよう指導している。改正GMP省令においてもリスクベースドアプローチをとるのであれば、省令のタイトルから基準を外すべきである。
今般の改正で、3基準書（衛生管理基準書、製造管理基準書、品質管理基準書）が手順になった。
また、バリデーション基準がバリデーション指針と名称が変更になった。
なぜ、省令タイトルのみが基準のままなのであろうか。

製造部門と品質部門に分けている。

製造部門、品質管理部門（QC）、品質保証部門（QA）とし、品質保証部門は独立しているべきである。
省令の要求では、品質保証部門は、製造管理者および品質部門長の配下になっている。
本来、品質保証部門は独立した権限が与えられており、何人からもバイアスを受けないことが望まれる。
品質部門の下に品質保証部門を置いたために、従来の品質管理（QC）部門は、試験検査に係る業務を担当する組織となっており、これも分かり辛い。

逐条解説に用語の定義が追加でなされている。

2つではあるが「計器の校正」「ロットを構成しない血液製剤」の定義が逐条解説に掲載されている。

その他、改正GMP省令に関する要点や問題点はYouTubeのビデオを参照されたい。

お役立ち動画

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[blogcard url=”https://ecompliance.co.jp/SHOP/O064.html” title=”【VOD】日本一わかりやすい【超入門】改正GMP省令セミナー” content=”厚生労働省は「医薬品および医薬部外品の製造管理及び品質管理の基準に関する省令」（GMP省令）の一部を改正する省令（厚生労働省令第90号）を発出しました。
2021年8月1日の施行を予定しています。

GMPの改正に伴い、この際基礎からGMPを学びたいという方々のために『超入門改正GMP省令セミナー』を企画いたしました。
改正GMP省令では、医薬品品質システム（ICH Q10）、品質リスクマネジメント（ICH Q9）、データインテグリティ、マネジメントレビュ、品質マニュアルなどの難解な用語や概念が出てきます。
これらを日本一わかりやすく解説いたします。
1回聞いただけでは理解できない方にも、アーカイブ配信を繰り返し視聴して頂けたら、きっとGMPを熟知できるようになるでしょう。

本セミナーは、これからGMPを勉強する方にもわかりやすく、基本からお話しを致します。また既にGMPを理解されている方にも再確認して頂ける内容となっています。
本セミナーでは、品質マニュアルのサンプルも配布いたします。”]

[blogcard url=”https://ecompliance.co.jp/SHOP/EL-081.html” title=”【セミナービデオ】日本一わかりやすい【超入門】改正GMP省令セミナー” content=”厚生労働省は「医薬品および医薬部外品の製造管理及び品質管理の基準に関する省令」（GMP省令）の一部を改正する省令（厚生労働省令第90号）を発出しました。
2021年8月1日の施行を予定しています。

GMPの改正に伴い、この際基礎からGMPを学びたいという方々のために『超入門改正GMP省令セミナー』を企画いたしました。
改正GMP省令では、医薬品品質システム（ICH Q10）、品質リスクマネジメント（ICH Q9）、データインテグリティ、マネジメントレビュ、品質マニュアルなどの難解な用語や概念が出てきます。
これらを日本一わかりやすく解説いたします。
1回聞いただけでは理解できない方にも、アーカイブ配信を繰り返し視聴して頂けたら、きっとGMPを熟知できるようになるでしょう。

本セミナーは、これからGMPを勉強する方にもわかりやすく、基本からお話しを致します。また既にGMPを理解されている方にも再確認して頂ける内容となっています。
本セミナーでは、品質マニュアルのサンプルも配布いたします。”]

[blogcard url=”https://ecompliance.co.jp/SHOP/O060.html” title=”【VOD】改正GMP省令要点セミナー” content=”厚生労働省は「医薬品及び医薬部外品の製造管理及び品質管理の基準に関する省令」（GMP省令）の一部を改正する省令（厚生労働省令第90号 ）を発出しました。
2021年8月1日の施行を予定しています。

GMP施行通知の施行（2013年8月30日）から8年近く経過し、いよいよGMP省令が改正されます。
改正GMP省令は、ICHやPIC/S等の国際標準のGMP基準に整合されました。
特にICH-Q9（品質リスクマネジメント）やICH-Q10（医薬品品質システム）の遵守が求められます。
それにより、品質保証体制の充実が求められることとなりました。

しかしながら、改正GMP省令はPIC/S GMPとの差異も存在します。
いったい何が変わり、どういう要求事項になっているのでしょうか。

改正GMP省令は、PIC/S GMPガイドライン重要項目（6項目）に加え、おおよそ以下の要件が追加されました。

承認事項の遵守（第3条の2）
医薬品品質システム（第3条の3）
品質リスクマネジメント（第3条の4）
交叉汚染の防止（第8条の2）
安定性モニタリング（第11条の2）
製品品質の照査（第11条の3）
原料等の供給者の管理（第11条の4）
外部委託業者の管理（第11条の5）
また、用語の定義が充実しました。
例えば、「医薬品品質システム」､「品質リスクマネジメント」、「安定性モニタリング」、「最終製品」、「参考品」､「保存品」、「是正措置」、「予防措置」、「品質」などが第2条（定義）に追記されます。

いったいどのような手順書（SOP）を作成すれば良いのでしょうか。

【医薬品品質システム】
ICH Q10（医薬品品質システム）の取り込みはグローバルな流れでもあります。
したがって、改正GMP省令においては、ICH Q10の浸透が強く要求されます。
では、医薬品品質システムとはいったい何でしょうか。
医薬品品質システムにおいては、経営層（トップマネジメント）の関与が求められます。
トップマネジメントは、医薬品品質システムの確立と実施の責任を持ちます。
また、定期的にマネジメントレビュによって品質をレビュし、医薬品品質システムの見直しを実施しなければなりません。
それにより、医薬品のライフサイクル全期間での継続的改善を促進することとなります。

また、製造所においては、従来の品質部門に品質保証に係る業務を担う組織（QA）の設置が規定されます。
製造管理者の管理監督の下、品質保証に係わる業務を実際に遂行する組織としての手順書の作成と実施が求められます。
また、外部試験検査機関等の供給者管理も厳格化されます。
供給者監査の実施や供給者における変更管理も把握する必要があります。
さらに品質保証部門（QA）は、是正措置や予防措置（CAPA）を通じて、品質の改善を実施しなければなりません。

【品質リスクマネジメント】
これまでICH-Q9 「品質リスクマネジメントに関するガイドライン」は課長通知として発出されていました。
しかし、改正GMP省令においては、適切に品質リスクマネジメントが活用されるよう、ICHQ9の原則に則して手順書の作成と実施が求められます。
さらに品質リスクマネジメントの適用範囲として、「製品の製造管理及び品質管理」 だけでなく、「製造所における医薬品品質システム（PQS）」も対象となります。

本セミナーは、改正GMP省令と現行のGMP省令の対比表、品質マニュアルのサンプルなど充実した資料を配布し、分かりやすく90分間で改正GMP省令のポイントを解説いたします。”]

[blogcard url=”https://ecompliance.co.jp/SHOP/EL-077.html” title=”【セミナービデオ】改正GMP省令要点セミナー” content=”厚生労働省は「医薬品及び医薬部外品の製造管理及び品質管理の基準に関する省令」（GMP省令）の一部を改正する省令（厚生労働省令第90号 ）を発出しました。
2021年8月1日の施行を予定しています。

GMP施行通知の施行（2013年8月30日）から8年近く経過し、いよいよGMP省令が改正されます。
改正GMP省令は、ICHやPIC/S等の国際標準のGMP基準に整合されました。
特にICH-Q9（品質リスクマネジメント）やICH-Q10（医薬品品質システム）の遵守が求められます。
それにより、品質保証体制の充実が求められることとなりました。

しかしながら、改正GMP省令はPIC/S GMPとの差異も存在します。
いったい何が変わり、どういう要求事項になっているのでしょうか。

改正GMP省令は、PIC/S GMPガイドライン重要項目（6項目）に加え、おおよそ以下の要件が追加されました。

承認事項の遵守（第3条の2）
医薬品品質システム（第3条の3）
品質リスクマネジメント（第3条の4）
交叉汚染の防止（第8条の2）
安定性モニタリング（第11条の2）
製品品質の照査（第11条の3）
原料等の供給者の管理（第11条の4）
外部委託業者の管理（第11条の5）
また、用語の定義が充実しました。
例えば、「医薬品品質システム」､「品質リスクマネジメント」、「安定性モニタリング」、「最終製品」、「参考品」､「保存品」、「是正措置」、「予防措置」、「品質」などが第2条（定義）に追記されます。

いったいどのような手順書（SOP）を作成すれば良いのでしょうか。

【医薬品品質システム】
ICH Q10（医薬品品質システム）の取り込みはグローバルな流れでもあります。
したがって、改正GMP省令においては、ICH Q10の浸透が強く要求されます。
では、医薬品品質システムとはいったい何でしょうか。
医薬品品質システムにおいては、経営層（トップマネジメント）の関与が求められます。
トップマネジメントは、医薬品品質システムの確立と実施の責任を持ちます。
また、定期的にマネジメントレビュによって品質をレビュし、医薬品品質システムの見直しを実施しなければなりません。
それにより、医薬品のライフサイクル全期間での継続的改善を促進することとなります。

また、製造所においては、従来の品質部門に品質保証に係る業務を担う組織（QA）の設置が規定されます。
製造管理者の管理監督の下、品質保証に係わる業務を実際に遂行する組織としての手順書の作成と実施が求められます。
また、外部試験検査機関等の供給者管理も厳格化されます。
供給者監査の実施や供給者における変更管理も把握する必要があります。
さらに品質保証部門（QA）は、是正措置や予防措置（CAPA）を通じて、品質の改善を実施しなければなりません。

【品質リスクマネジメント】
これまでICH-Q9 「品質リスクマネジメントに関するガイドライン」は課長通知として発出されていました。
しかし、改正GMP省令においては、適切に品質リスクマネジメントが活用されるよう、ICHQ9の原則に則して手順書の作成と実施が求められます。
さらに品質リスクマネジメントの適用範囲として、「製品の製造管理及び品質管理」 だけでなく、「製造所における医薬品品質システム（PQS）」も対象となります。

本セミナーは、改正GMP省令と現行のGMP省令の対比表、品質マニュアルのサンプルなど充実した資料を配布し、分かりやすく90分間で改正GMP省令のポイントを解説いたします。”]

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