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  • 润柏医药公司再次零缺陷通过FDA现场审计

    2016-07-05 17:28:45
    润柏医药公司再次零缺陷通过FDA现场审计
            2016年6月27日-6月30日,美国食品与药品监督管理局(FDA)检察官对石家庄润柏医药科技有限公司(以下简称“润柏公司”)进行了现场检查,并于六月三十日作出了零483即零缺陷通过的结论。这标志着润柏实验室第二次以100 分的成绩顺利通过美国FDA认证。在当前FDA对中国药企严格检查和数据完整性问题迭出的今天,"零缺陷"通过的优异成绩着实来之不易。
           
        FDA是公认的全球药品质量监管最权威、最严格的机构,早在2013年7月份,润柏公司首次以独立检测实验室身份零缺陷通过FDA现场检查,成为全国首家以独立检测实验室身份通过美国FDA认证的高科技企业。今天,润柏公司再次以"零缺陷"优异表现通过FDA现场检查标志着我司质量体系建设和检测能力经受住考验,与时俱进,成为达到当前最高国际GMP水准的标杆企业。
           
        石家庄润柏医药科技有限公司再次通过FDA认证,为帮助国内制药企业获得欧美法规市场通行证,克服贸易和技术壁垒,进军国际高端医药市场将起到坚实有力的推动作用;同时也将为中国生物制药工业按照国际最高质量标准参与新产品、新技术研发树立了新的质量标杆。


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