润柏医药公司再次零缺陷通过FDA现场审计

润柏医药公司再次零缺陷通过FDA现场审计
2016-07-05 17:28:45
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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润柏医药公司再次零缺陷通过FDA现场审计

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