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案（概要）（以下、改正案）に関する意見募集（パブリックコメントの募集）を2020年11月27日から開始し、2020年12月26日に締め切った。
改正GMP省令は、2021年4月公布、8月1日の施行を予定している。
当初は、2018年10月に施行される予定だったが、薬機法の改正が遅れ、またコロナ禍などが重なり、遅延したものと思われる。
前回のGMP改正が平成17年であるので、16年ぶりの大改正である。
改正GMP省令に関してはこれまで「GMP、QMS及びGCTPのガイドラインの国際整合化に関する研究」（研究代表者：櫻井信豪氏）が実施されてきた。
また改正GMP省令（案）としては、2018年7月12日に開催された、第45回 2018年度GMP事例研究会資料『GMP省令改正案とPMDA査察の事例及び今後の方向性について』と題した発表が唯一の文献であり、この中で省令案文（以下、研究班案）とコンセプト、施行通知案文等が公表されていた。
改正案は、全改正ではなく、一部改正の手法を用いている。したがって、条番号に変更はない。そのため、従前から要求を追加する場合には、第11条 第2項、第11条 第3項といった具合に項番が増えている。
残念なことは、改正案は研究班案から大きく後退していることであると筆者は感じている。
改正案では、研究班案にはあった、上級経営陣の責任、情報伝達などについては記載がない。
特に「データインテグリティ」（文書及び記録の完全性）に関する要求は見当たらない。
第3条の2（承認事項の遵守）においては、過去に発覚した不正などについて再発防止を図ったものであろう。
改正案で最も大きな追加要求事項は、第3条の3（医薬品品質システム）であろう。
「医薬品品質システム」はICH Q10 「品質システムに関するガイドライン」で要求されているものである。
“品質システム”とは何かについては、紙面の都合上割愛するが、詳しく知りたい場合は筆者の講演等を参考にされたい。
「医薬品品質システム」は、PDCAが基本であり、“上級経営陣”すなわち社長や取締役などは、品質方針を定め、組織に品質マネジメントシステム（QMS）を構築させなければならない。
“上級経営陣”は、経営責任だけではなく品質保証に関しても責任を持ち、リーダーシップをもって組織を運営していかなければならない。
つまりガバナンス（統治）が求められている。
今後、改正GMP省令に関するセミナーや書籍の販売が活発になると予想されるが、それらは玉石混交であり、真贋を見極めることが大切である。なぜならば、本邦においてこれまで製薬企業には“品質システム”といった概念が根づいておらず、経験者もそう多くないためである。
“品質システム”（品質マネジメントシステム：QMS）は、ISO 9001などの品質マネジメント規格などによって国際的にスタンダードが確立されている。
FDAも2006年9月に「品質システムからのアプローチ」と題したcGMPを補完するガイダンスを発表している。
第3条の4（品質リスクマネジメント）は、ICH Q9に従い、リスクベースドアプローチをとることを要求している。
リスクベースドアプローチについては、筆者の講演等を参考にされたい。
また第4条において、品質部門は「品質管理部門」（QC）と「品質保証部門」（QA）に明確に分離された。
品質保証部門は、独立した責任と権限を持ち出荷判定を中心とした品質保証業務を実施しなければならない。従前にも増して、品質保証部門の責任は重くなっている。
第8条（手順書等）では、作成すべき具体的な手順書名が明記された。
これまで3基準書である「製造管理基準」「品質管理基準」「衛生管理基準」は廃止され、それぞれ手順書として定めることになった。
おそらく、リスクベースドアプローチをとることなどから、“基準”をあらかじめ定めることがそぐわなくなったものではないかと筆者は考える。
第11条（品質管理）においては、「安定性モニタリング」「製品品質の照査」「原料等の供給者の管理」などが追加されたが、これまでもPIC/S GMPで要求されてきたもので、施行通知にはすでに反映されていたものである。
第3章 医薬部外品に関しては、従前の医薬品の準用から詳細な要求に変更され、充実した。
これは医薬品と医薬部外品ではリスクが異なるためであると考えられる。
余談であるが、改正案では、第3節 無菌医薬品の製造管理及び品質管理の第25条(教育訓練)がない。その理由をご存じであればぜひご教授願いたい。
当社では、今後、本メルマガやホームページなどを通じて、正しい理解を広めるため、改正GMP省令や改正QMS省令に関する情報を発信していきたい。
GMP省令は2021年4月28日付で改正されました。詳しくはこちら。
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お好きな時間に、繰り返し何度でもご視聴いただけます。
・（全5コース）】改正GMPセミナーシリーズ【一括受講コース】
※単独コースのお申し込みはこちら。
『医薬品品質システム編』
『品質リスクマネジメント編』
『CAPA編』
『データインテグリティ編』
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・日本一わかりやすい【超入門】改正GMP省令セミナー
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・改正GMP省令対応にむけた管理監督者のGMP教育/「企業文化」改善で事故削減の事例
・改正GMP省令を踏まえた中小規模企業のサイトQA業務と組織体制づくり
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