改正QMS省令対応の要点

【連載】QMS省令改正について

【第1回】QMS省令改正

はじめに

2014年11月25日に、薬事法が一部改正され「医薬品、医療機器等の品質、有効性および安全性の確保等に関する法律」 (医薬品医療機器等法:薬機法)が施行された。
実は「薬事法等の一部を改正する法律」第66条には以下のように規定されている。

第66条 (検討)
政府は、この法律の施行後5年を目途として、この法律による改正後の規定の実施状況を勘案し、必要があると認めるときは、当該規定について検討を加え、その結果に基づいて必要な措置を講ずるものとする。

この検討条項に従い、現在、厚生労働省において以下3点をテーマに据えた「改正法の施行後5年を目途とした検討」が行なわれている。

テーマ① 革新的な医薬品・医療機器等への迅速なアクセス確保・安全対策の充実
テーマ② 医薬品・医療機器等の適切な製造・流通・販売を確保する仕組みの充実
テーマ③ 薬局・薬剤師のあり方・医薬品の安全な入手

QMS省令の改正は、テーマ①の一環であり、平成29年度 厚生労働科学研究「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)において改正QMS省令(案)および逐条解説(案)を検討している。
つまりGMPの改正と共にQMS省令の改正も本薬機法見直しの一環として検討がなされている。
また、上記研究においてQMS班では「電磁的な文書及び記録の管理に関するガイダンスの作成」に関する検討も実施。
品質管理監督システム(QMS)に用いられるソフトウエアにバリデーションが課されることから、医薬品GMPにおける「コンピュータ化システム適正管理ガイドライン」を参考にQMS版ガイドラインの作成手順および作成の必要性検討のためのアンケートも実施した。

改正QMS省令は当初2018年10月に施行される予定であった。しかしながら本日現在、案の公表すらされていない。

改正QMS省令の要点

改正QMS省令では、第2章部分をISO13485:2016に準拠させる。
改正のポイントは以下のとおりである。

①リスクに基づくアプローチの適用
②品質マネジメントシステムで用いるソフトウエアにバリデーションを適用
③統計学的方法に基づくサンプルサイズ

上記に加え、苦情処理・滅菌医療機器の要求事項の強化、文書化、記録作成等の要求事項の追加がなされる。
今年度中に公布・施行予定である。ただし、適用までに3年の猶予期間を設ける予定だ。

改正QMS省令において頻回登場する用語

以下の用語が改正QMS省令では頻回し登場している。

  • 文書化
  • リスク
  • 規制当局(厚生労働省等)
  • 統計学的方法
  • 要領書

特に「要領書」に注意が必要である。これまでは「手順書」の作成に重きを置いてきた。
しかしながら、通常は手順書を見ながら作業はしない。また手順を見たとしても具体的な作業方法までは記載されていない。つまり「手順書」のみでは実効性がないのである。
改正QMS省令では実効性を重んじている。
「要領書」とは具体的な作業方法が記載されてものである。
例えば、供給者に「取交し書」や「契約書」を締結するのみであったり、「手順書」を交付しても意味がなく具体的な「要領書」を交付しなければ品質の担保ができない。

改正後は、具体的な「要領書」の作成が求められる。

(次号に続く)

QMS省令は2021年3月26日に改正されました。詳しくはこちら

関連商品

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