改正GMP省令で作成が要求されている手順書は17種類である。（第8条）
１．構造設備および職員の衛生管理に関する手順
２．製造工程、製造設備、原料、資材および製品の管理に関する手順
３．試験検査設備および検体の管理その他適切な試験検査の実施に必要な手順４．安定性モニタリングに関する手順
５．製品品質の照査に関する手順
６．原料および資材の供給者の管理に関する手順
７．製造業者等の委託を受けて試験検査その他の製造・品質関連業務の一部を行う他の事業者の管理に関する手順
８．製造所からの出荷の管理に関する手順
９．バリデーションに関する手順
１０．第14条の変更の管理に関する手順
１１．第15条の逸脱の管理に関する手順
１２．第16条の品質情報および品質不良等の処理に関する手順
１３．回収等の処理に関する手順
１４．自己点検に関する手順
１５．教育訓練に関する手順
１６．文書および記録の作成、改訂および保管に関する手順
１７．その他適正かつ円滑な製造・品質関連業務に必要な手順
3基準書の廃止（手順書化）
従前の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）が廃止され、手順書となった。（上記の赤字部分）
・衛生管理基準書 → 構造設備および職員の衛生管理に関する手順
・製造管理基準書 → 製造工程、製造設備、原料、資材および製品の管理に関する手順
・品質管理基準書 → 試験検査設備および検体の管理その他適切な試験検査の実施に必要な手順
また、GMP施行通知（2013/8/30）でPIC/S GMPに整合すべく追加されていた下記の4手順書も追加された。（上記の青字部分）
・安定性モニタリングに関する手順
・製品品質の照査に関する手順
・原料および資材の供給者の管理に関する手順
・製造業者等の委託を受けて試験検査その他の製造・品質関連業務の一部を行う他の事業者の管理に関する手順
品質リスクマネジメントとデータインテグリティ手順書の作成が要求されていない理由
データインテグリティおよび品質リスクマネジメントは、全部門、全プロセス（全手順書）において対象となる。
従って、データインテグリティおよび品質リスクマネジメントを担当する専門組織を組織する訳ではない。また新たに品質リスクマネジメント手順書やデータインテグリティ手順書を作成する訳でもない。
既存の各手順書にデータインテグリティおよび品質リスクマネジメントの概念を挿入すること。
ここで問題なのは、品質リスクマネジメントのガイドラインは2005年に発出されているが、データインテグリティに関するガイドラインが本邦には存在しないということである。
改正GMP省令で要求が漏れている手順書
品質マニュアル
改正GMP省令では医薬品品質システム（PQS）の構築が必須となった。
PQSにおける最上位の文書は「品質マニュアル」である。逐条解説にもその旨の記載がある。
しかしながら、改正GMP省令では品質マニュアルを作成するように明確な要求の記載がない。
ただし、品質方針を作成するといった要求はある。しかしながら、品質方針と品質マニュアルは別のもので、ISO 9001などでは品質マニュアルの中に品質方針を記載するのが一般的である。
マネジメントレビュ手順書
同じくPQSを構築するうえで肝心なのはマネジメントレビュであろう。
品質マニュアルと同様に逐条解説で定期的なマネジメントレビュの実施を要求している。
しかしながら、改正GMP省令ではマネジメントレビュを実施するための手順書作成要求がない。
また改正GMP省令では、マネジメントレビュ実施の具体的な要求がない。
・誰が上級経営陣（省令では製造業者等）に報告するのか（インプットを作成するのか）
・誰がマネジメントレビュに参加しなければならないのか
・マネジメントレビュは会議なのか回議でも良いのか
今般のグローバル化の流れにおいてPIC/S GMPやICH Q10の一層の浸透が望まれる。
しかしながら、上記の通りPQSに関しての記載が乏しい。 今後発出される予定の事例集などに詳細が記載されることを望む。
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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/O071.html” title=”【VOD】（全5コース）改正GMPセミナーシリーズ【一括受講コース】” content=””]
[blogcard url=”https://ecompliance.co.jp/SHOP/EL-088.html” title=”【セミナービデオ】（全5コース）改正GMPセミナーシリーズ【一括受講コース】” content=””]
[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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