『保健医療科学』 2022 第71巻 第2号 p.147-155（2022年5月）
特集：最近の薬事行政の話題と改正GMP省令について ＜総説＞
改正GMP省令のポイント
三嶋克彦
独立行政法人医薬品医療機器総合機構関西支部
Points of the revised GMP Ministerial Ordinance with reference to its expected roles in prevention of recently arising pharmaceutical quality issues
MISHIMA Katsuhiko
Kansai Branch, Pharmaceuticals and Medical Devices Agency
抄録
近年，GMP管理の重大な不備や組織的な不正による製品回収が後を絶たたない.品質問題の再発を防止し，医薬品業界全体に対する国民の信頼を取り戻すことは，製造販売業者，製造業者，行政当 局が最優先で果たすべき責務であり，継続的な対応が必要不可欠である.
一方，改正医薬品医療機器等法が2021年8月1日付けで施行され，法令遵守体制の整備等が製薬企業の義務として規定された.
また，同日付けで施行された改正GMP省令においては，製造所における医薬品品質システムの導入等により，更なる国際整合が図られるとともに，昨今の品質問題の再発防止の要素が随所に盛り込まれた.
本稿では，品質問題の再発の防止を見据え，改正GMP省令で新たに追加された項目及びその背景について，関連通知にも触れながら紹介する.
キーワード: GMP，医薬品品質システム，品質問題
Abstract
Recently, product recalls have been repeatedly reported owing to quality issues caused by critical failures of GMP control and organizational fraud. Preventing recurrence of quality issues to regain public trust in the pharmaceutical industry is a top-priority duty of marketing authorization holders, manufacturers, and regulatory authorities.
Meanwhile, the revised Act on Securing Quality, Efficacy, and Safety of Pharmaceuticals, Medical Devices, Regenerative, and Cellular Therapy Products (PMD Act) was enforced on August 1, 2021, by which the establishment of a legal compliance system was stipulated as a duty for pharmaceutical industries.
On the same day, the revised GMP Ministerial Ordinance (GMP-MO) was also enforced to introduce the Pharmaceutical Quality System in manufacturing sites, aiming for the international harmonization of GMP standards as well as prevention of the recurrence of quality issues.
In this paper, I outline the expected roles of the revised GMP-MO in the prevention of quality issues, focusing on its revisions and the background of the revisions, with reference to relevant notifications.
keywords: GMP, PQS, quality issues
