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  • 質量管理體系

        公司按照中國和歐盟GMP標準建立了全面質量管理體系,確保產品的質量,安全和有效性。設立質量管理委員會,由質量負責人全面負責,質量保證部負責日常質量監測,其他部門責任明確。

        公司管理層通過監管、自查、定期質量會議等方式參與質量管理工作。歐盟QP定期訪問,為公司提供培訓和咨詢服務。公司每年參加MHRA GMP研討會,并參加MHRA / BGMA質量論壇。


        公司的產品質量管理貫穿產品的整個生命周期,確保預期的質量可以一貫和穩定地實現。公司的決策基于風險管理原則,確保將質量風險最小化。完善的文件和記錄管理制度,有效規范所有操作,并確保記錄真實性、準確性、及時性和可追溯性。完善的驗證/資格制度,保障對生產設施,設備,工藝和檢驗方法的有效控制狀態。公司還建立了完善的 供應商管理體系,完善的變更控制、偏差、OOS、投訴和CAPA體系,以及完善的日常監測和自檢體系。

        公司密切關注法規的更新,及時采取必要的措施保證符合法規要求。公司根據MHRA指南和世界衛生組織和FDA的指導文件建立數據完整性體系,確保ALCOA原則貫穿數據的整個生命周期。

        公司建立了完善的培訓體系,確保所有員工獲得必要的培訓以滿足工作需求。從員工進入公司開始,GMP培訓就貫徹到所有工作中,并將貫穿員工的整個職業生涯。

        建立全面完善的質量管理體系不僅僅是法規要求,也是華益的“責任、品質、共贏”宗旨的要求。公司以高度的社會責任投身于制藥行業,以全面完善的質量體系保障產品的質量,為患者提供高品質的藥品,實現患者健康和企業蓬勃發展的共贏目標。

    必发快3
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