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30

2022

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08


      近日,卓峰制药新厂区一期小容量注射剂项目基建工程及生产配套设备设施安装接近尾声,总经理李留智在周例会上做出部署,新厂区小容量注射剂车间10月份通过省药监局初验,年底之前通过国家食品药品监督管理局GMP认证,从现在起开始启动认证工作。

      李总指出,抽调到新厂区负责迎验的人员8月10号以前到位,拿出认证时间进度安排表,统筹兼顾,在时间上要提速,全力推进认证工作。

      按照李总的要求,认证工作硬件建设方面包括完善设备仪器档案资质、化验室设计验收、计量仪器的校验、工艺管线连接、车间地面自流坪制作、空调系统安装调试、空调系统洁净度验收检查、制水系统验证、库房各类设施配备、锅炉房验收制定了详尽的时间计划;软件资料文件方面包括文件系统建立健全、验证总计划、化验室和车间空调净化系统确认、洗灌封联动线等设备确认、工艺验证、清洁验证、检验方法确认等一系列软件资料的整理倒排时间表按程序推进;物料方面包括供应商现场审计和资质索取、物料采购、物料检验放行制定了详细的措施;人员培训方面包括企业年度培训计划、培训资料整理、个人培训档案制定了时间规划。

      李总指出,卓峰制药新厂区按照2010版GMP认证,在时间上、规模上都是领先的,下半年一切工作以新厂认证验收为重点,各块要努力工作,克服困难,团结协作,确保一次性顺利通过国家局认证。
 

这里是占位文字

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