雙成藥業(002693.SZ)子公司通過美國FDA現場檢查
格隆匯12月13日丨雙成藥業(002693.SZ)公佈,公司控股子公司寧波雙成藥業有限公司(“寧波雙成”)於2019年10月14日至2019年10月18日接受了美國食品藥品監督管理局(“FDA”)的藥品批准前現場檢查,此次CGMP(現行藥品生產質量管理規範)檢查涉及製劑產品。
公司控股子公司寧波雙成於近日收到FDA的通知,按照美國21CFR法規,FDA確認該檢查已結束,並提供給公司此次檢查的報告。該通知和檢查報告已明確公司通過了此次美國FDACGMP檢查,寧波雙成的質量管理體系符合美國FDACGMP的要求。
美國CGMP是國際醫藥行業公認的最高標準的藥品質量管理規範,是最嚴格的藥品生產質量管理體系。國際GMP的標準旨在通過追求嚴格的質量控制和改進措施,以保證產品的質量,進而保障患者的健康與安全。良好的質量體系是公司長期堅持國際化戰略的結果,為公司的產品質量和國際市場開拓奠定了紮實的基礎,對公司未來發展有着積極的推動作用。
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