改正GMP省令 医薬品品質システムの要点

医薬品規制などで要求される「品質システム」(QS:Quality System)とISO 9001ISO 13485などの品質マネジメント規格で要求される「品質管理システム」(QMS:Quality Management System)は同義である。
医薬品品質システム(PQS: Pharmaceutical Quality System)はICH Q10で要求されている。
 従来ICH Q10の準拠は任意であった。しかしながら改正 GMP 省令では医薬品品質システムのインプリメンテーションは必須となった。 
品質システムとは、品質を“改善”する“仕組み”のことである。品質システム(QS)はPDCA(Plan、Do、Check、Action)が基本である。
品質システム(PDCA)が存在するということは、今日よりも明日、明日よりも明後日は品質が向上するといった保証があるということである。
ここで継続的な改善が重要となる。

PDCAのサイクルと再発防止
企業のトップ以下が全員参加で、PDCAのサイクルを回し続け、企業全体がスパイラルアッ プ するシステムを構築しなければならない。 
そのためには、内部監査と是正処置が企業の体質の強化にとってきわめて重要である。
企業体質を向上させるチャンスを自ら放棄するような原因究明の省略は厳に慎まなければならない。
同じ不適合が何度も繰り返して起きることがないような再発防止のシステム作りが大切である。
一概に単純な不適合だから単なる修正をするだけで良いとか、原因究明や再発防止をする必要がないと考えるのは企業のスパイラルアップのために得策ではない。
単純な不適合こそ、原因究明や再発防止を怠ると、モグラ叩きのようにまた同じ不適合が繰り返されてしまい、PDCAのサイクルが回らなくなってしまうのである。
医薬品品質システムにおいては、顧客苦情などの収集を行い再発防止に向けた是正措置・予防措置(CAPA)を行うこと。
是正措置で重要なことは、問題の根本的原因を調査し、それを解消することにより、再発を防止することである。ここで是正と修正は異なることに注意しなければならない。 
内部監査を実施し、潜在している問題点(つまりリスク)を自ら発見すること。内部監査は、PIC/S GMPでは「Self Inspection」(自主的な査察)と呼ばれている。
Self Inspectionは、日本の省令等では「自己点検」と訳されているが、この用語は適切ではない。Self Inspectionでは、企業自らの内部監査等によって、日々リスクを発見し、是正・予防することが重要である。つまり当局査察で指摘されるのを待って改善するのではなく、企業自らが積極的に改善活動を実施すること。
是正措置・予防措置(CAPA)や内部監査の結果は、上級経営陣にフィードバックすること。
上級経営陣が、マネジメントレビュなどによって改善指示を出し、次年度の品質目標をたてることになる。

医薬品品質システムの4つの要素 
「医薬品品質システム」は4つの要素から成る。

  1. 製造プロセスの稼働性能および製品品質のモニタリングシステム
  2. 是正措置および予防措置(CAPA)システム
  3. 変更マネジメントシステム
  4. マネジメントレビュ

上級経営陣の責任 
PIC/S GMPの“上級経営陣”(Senior Management)は、改正GMP省令では“製造業者等”と表記されているので紛らわしい。
上級経営陣とは、法人たる製造業者等の代表者を含む薬事に関する業務に責任を有する役員のことである。
上級経営陣が実効性(有効性)のある「医薬品品質システム」(PQS)の確立と実施の責任を持つ。
上級経営陣は企業を管理された状態(State of Control)に置くこと。
上級経営陣が医薬品品質システムに係る重要事項に関して責任を負う(ICH Q10)

  1. 品質方針の確立
  2. 品質目標の設定と周知および評価
  3. 適切な資源配分および従業員への教育訓練の提供
  4. マネジメントレビュの実施
  5. 情報伝達の仕組みの構築/維持

上級経営陣は、品質マニュアルを作成すること。
上級経営陣は、品質方針を作成すること。品質方針は経営方針と整合していなければならない。
上級経営陣は、各部門に年度毎に製造責任者(品質保証部門)に品質目標を立てさせること。品質方針と品質目標は整合していなければならない。
品質目標では、達成可能な目標であることと、具体的な数値とともにその達成基準が明確になっていなければならない。
例えば、顧客苦情を3ポイント減少させる、逸脱を5ポイント下げる、顧客満足度を10ポイント増加させるなどである。
上級経営陣は、製造管理者に独立した権限と責任を与えること。
上級経営陣は、適切なリソース(人、モノ、金)を準備すること。口頭で指示する(頑張りなさい。しっかりしなさい。ちゃんとやりなさい。)だけでリソースを準備しなければ、品質改善が実行できないからである。
例えば、要員を雇用する、教育訓練を実施する、コンサルタントを雇うなどである。
上級経営陣は、少なくとも年に1回のマネジメントレビュを実施すること。
マネジメントレビュは「経営者による見直し」と訳すのが適切である。 では何を見直すのかと言うと「品質システム」および「リソース」である。
上級経営陣は、品質改善に関する適切な指示を出さなければならない。

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[blogcard url=”https://ecompliance.co.jp/SHOP/O066.html” title=”【VOD】【180分で要点を学ぶ】改正GMPセミナーシリーズ 医薬品品質システム編 ” content=”2021年8月1日から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。
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。
医薬品品質システムにおいては、
・マネジメントレビュ
・製造プロセスの稼働性能および製品品質のモニタリングシステム
・是正措置および予防措置システム(CAPA)
・変更マネジメントシステム
といった4本の柱から構成されています。

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した。
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。
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。

本セミナーでは、難解なICH Q10を分かりやすく解説し、医薬品品質システム構築の要点をまとめます。
また、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-083.html” title=”【セミナービデオ】【180分で要点を学ぶ】改正GMPセミナーシリーズ 医薬品品質システム編 ” content=”2021年8月1日から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。
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。
医薬品品質システムにおいては、
・マネジメントレビュ
・製造プロセスの稼働性能および製品品質のモニタリングシステム
・是正措置および予防措置システム(CAPA)
・変更マネジメントシステム
といった4本の柱から構成されています。

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した。
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。
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。

本セミナーでは、難解なICH Q10を分かりやすく解説し、医薬品品質システム構築の要点をまとめます。
また、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)【180分で要点を学ぶ】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)【180分で要点を学ぶ】改正GMPセミナーシリーズ【一括受講コース】 ” content=”厚生”]

[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。”]

[blogcard url=”https://ecompliance.co.jp/SHOP/O053.html” title=”【VOD】GMP省令改正における「原料等の供給者管理」の対応” content=”PIC/S GMPとの6つのギャップの一つとして、今まで、施行通知で求められていたが、GMP省令が改正され、盛り込まれることになった。今後、原料等の供給者管理は、査察時の重要なポイントとして必ず確認される。しかし、原薬から原料、資材と幅広く、その品質への影響は差があり、取決めや監査について悩まれる点でもある。リスクマネジメントの概念を取り入れ、その取決めや監査のポイントを解説し、より効果的な供給者管理を実施のための手順を探る。”]

[blogcard url=”https://ecompliance.co.jp/SHOP/EL-070.html” title=”【セミナービデオ】GMP省令改正における「原料等の供給者管理」の対応” content=”PIC/S GMPとの6つのギャップの一つとして、今まで、施行通知で求められていたが、GMP省令が改正され、盛り込まれることになった。今後、原料等の供給者管理は、査察時の重要なポイントとして必ず確認される。しかし、原薬から原料、資材と幅広く、その品質への影響は差があり、取決めや監査について悩まれる点でもある。リスクマネジメントの概念を取り入れ、その取決めや監査のポイントを解説し、より効果的な供給者管理を実施のための手順を探る。”]

[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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