医薬品品質システムについて

改正GMP省令では、医薬品製造所は医薬品品質システム(PQS:Pharmaceutical Quality System)を構築することが求められる。
しかしながら、本来品質システムは製造所単位で構築すべきものではない。
品質システムは製造販売業が製造業を含めて構築しなければならない。
日本の場合、製造販売業者と製造業者を区別しているところに問題があると思われる。

医療機器規制は、2014年のQMS省令改正により、製造販売業者が製造業者を監視監督することとなった。
これに伴い、医療機器の製造業者は業許可ではなく、登録制となった。
QMS省令(もともとは医療機器GMP)は、製造販売業者にも適用されることとなった。
このような制度は医薬品にはない。

製造販売業者と製造業者が同一法人である場合、製造業側に経営者が存在しないケースがある。これでは品質マニュアルの構築、品質方針の立案、品質目標の設定等、マネジメントレビュの開催などにも支障をきたす。
例えば、製造所ごとに品質システムを構築した場合、その長が工場長となり、取締役ではないこともあり得る。
果たして工場長が経営方針を立て、品質方針を設定できるだろうか。
またマネジメントレビュ(経営者による見直し)を実施する権限が与えられっているだろうか。

苦情の収集は製造販売業者がGQP省令に則って実施することになる。
回収においても同様である。
製造業者は苦情に関しては製販業者から伝えられた「品質情報」の一環として対応するのみである。
一方で、FDAは21 CFR Part 211「§211.198 Complaint files(苦情ファイル)」において苦情の取扱いに関して詳細な規則を定めている。
これは日本と米国における規制要件の中で立て付けがかなり異なり、手順を作成する上で注意しなければならない点である。
ICH Q10「医薬品品質システムに関するガイドライン」においてはGMPの適用範囲以外に医薬品開発や技術移転を含んでおり、さらにGQP・GDPにも及んでいる。

本来、品質システムは製造販売業者が販売業者を包含し、医薬品開発・技術移転(CMC)・製造・流通(GDP)・市場品質監視(GQP)の全体をカバーすることが望ましい。

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