ご承知の通りGMPは「Good Manufacturing Practice」である。そのまま直訳すれば「実践製造規範」である。
しかしながら、厚生労働省令においては「医薬品および医薬部外品の製造管理および品質管理の基準に関する省令」となっている。
このタイトルは、改正GMP省令では改めて欲しいと筆者は考えている。
なぜならば、同じ医薬品であっても、「ビタミン剤」「栄養剤」と「抗がん剤」「向精神薬」「抗ウィルス薬」では”基準”は異なるはずだからだ。
GMPは1963年に米国FDAによってはじめて示された規則であるが、当時は確かに「基準」を示していた。
しかしながら、2002年にFDAが示した「Risk based Approach」においては、もはや当局は”基準”を示さず、製品やプロセスのリスクに応じて製薬企業が自ら”基準”を定めなければならないのである。
そのためには、企業はICH-Q9「品質リスクマネジメント」に従ってリスクアセスメントを実施し、その結果を文書化しておかなければならない。
その上で企業は当局に対して”基準”が適正であることを説明しなければならないのである。
「Risk based Approach」に移行した最大の理由は、患者負担の軽減である。
すべての医薬品やプロセスに対して同一の”基準”を課すことは不合理であり、いたずらにコンプライアンスコストを跳ね上げてしまうのである。
企業にとっても当局から”基準”を示された方が業務はし易い。
しかしながら「実践製造規範」であるため、プロフェッショナルな業務遂行が求められる。決して”基準”を示されなければ業務が出来ないといった素人考えでは患者の安全性を担保することはままならない。
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