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凯林制药连续第三次“零缺陷”通过美国FDA现场检查
2017-09-06 15:31:54 中国经济网
经济日报-中国经济网北京9月6日讯 (记者 李治国)记者近日从位于重庆的复星医药成员企业药友制药传来好消息:其旗下原料药生产企业——凯林制药以零缺陷的佳绩,连续第三次顺利通了过美国FDA现场检查。这是继2017年6月凯林制药顺利跨入“中国医药国际化百强企业”后,交出的又一份答卷。
近年来,美国FDA加大了对中国药品生产企业的检查力度,通过认证的难度越来越大。而本次认证,是FDA对凯林制药生产体系的系统性检查,检查范围更广、涉及层面更多。
检查期间,检查官全面、深入地审查了凯林制药质量管理系统、质量控制系统、设施设备系统、物料管理系统、生产管理系统、包装与贴签系统等cGMP涉及的六大系统,并对生产现场工艺、设备、环境、质量体系等进行了细致检查。检查官对凯林制药现场环境给予较好的肯定,对质量体系的有效运行给予很高评价,并现场宣布:凯林制药零缺陷顺利通过本次FDA现场检查。
药友制药副董事长、凯林制药执行董事王帆表示,此次顺利通过认证,是凯林制药一直严格贯彻执行cGMP标准的结果,同时也为凯林制药继续拓展国际市场,提高国际市场竞争力奠定了坚实的基础。
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