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桂林三金(002275.SZ):全資孫公司白帆生物通過歐盟QP審計
格隆匯 10-08 18:40

格隆匯10月8日丨桂林三金(002275.SZ)公佈,近日,公司全資孫公司白帆生物科技(上海)有限公司(簡稱“白帆生物”)收到來自歐盟質量受權人(Qualified Person, QP)簽發的審計報吿。

依據Eudralex Vol 4法規(歐盟GMP)以及ICH的指導原則,此次審計範圍涵蓋廠房設施、質量體系、QC、污染控制等生產的重要環節。QP審計報吿顯示:“白帆生物在設施和系統的發展上投入了大量的資源和努力,該設施的設計基於單次使用系統最為先進的理念,藥品質量體系的設計符合國際標準。”

作為一個高端單抗藥物的規模化生產基地,白帆生物無交叉抗體工廠於2020年9月正式投產。在質量管理方面,白帆生物儲備了大量有豐富質量管理經驗的人才,並建立了科學嚴格的質量管理體系,覆蓋從廠房設計到施工檢測、從供應審計到設備驗證、從產品研發到生產管控,並可運用先進的數字化信息管理系統進行全面的質量分析和控制。

白帆生物順利通過了歐盟QP審計,標誌着白帆生產基地符合歐盟GMP標準,有能力為在歐洲進行臨牀試驗的客户提供臨牀產品的生產製造服務。

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