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(2011-12-08)[2011-12-11]http://www.sda.gov.cn/WS01/CL0050/67510.html根据欧洲药品管理局最新公告,英国、法国药品监管机构和美国食品药品管理局于2011年11月7日-11日对Ben Venus Laboratories公司(简称“BVL公司”)在美国的生产场地进行联合GMP检查,发现其无菌灌装过程质量管理存在缺陷。该公司生产的楷莱(通用名“盐酸多柔比星脂质体注射液”)、万珂(通用名“注射用硼替佐米”)在我国上市使用。为保证公众用药安全,国家食品药品监管局组织对上述产品可能存在的
(2011-12-08) [2011-12-11] http://www.sda.gov.cn/WS01/CL0050/67510.html According to the latest announcement of the European Medicines Agency, Britain, the French drug regulatory agencies and the United States food The Drug Administration conducted a joint GMP inspection of Ben Venus Laboratories’ (“BVL”) manufacturing sites in the United States on November 7-11, 2011, and found defects in the quality control of its aseptic filling process. The company produces Kelai (common name “Doxorubicin Hydrochloride Injection ”), Wan Ke (common name “bortezomib for injection ”) in China market. In order to ensure the safety of public medication, the State Food and Drug Administration organized the possible existence of these products