台湾展旺生技无菌原料厂被欧盟部分撤销许可证

yc20160802

台湾展旺生技是全世界前三大培南类抗生素无菌原料的主要供应商。自2012年来多次通过通過美国FDA cGMP查厂。2016年通過英国MHRA复查。但是2018年欧盟GMP查厂发现关键缺陷，部分撤除许可证。

EMA retractslicense from Taiwanese sterile drugmaker over serious non-compliance May 22, 2018

The EuropeanMedicines Agency (EMA) is withdrawing the license of Taiwan-based Savior Liftecafter the discovery of serious Good Manufacturing Practice (GMP) non-complianceafter an inspection conducted in May.

According to theEMA, the scope of this statement of non-compliance is limited to medicinalproducts considered non-critical to public health. The inspection identified acritical deficiency relating to the aseptic processing of Meropenem andMeropenem/Sodium Carbonate blend. The deficiency related to a lack of technicalknowledge regarding sterile processing and included elements such as, autoclaveand dry heat sterilization of equipment, inadequate VHP load pattern design andapplication, media fills and environmental monitoring.

As a result of theGMP non-compliance the EMA has issued a statement of non-compliance andrestricted GMP certificate to permit continued manufacture and testing ofsterile API considered to be medically critical or to ensure continuity ofsupply, as determined by the national competent authority. No batches ofnon-critical product will be supplied to EU markets whilst this statement ofnon-compliance remains in force. There will however be no recalls of productalready released.

EMA因严重违反GMP规定而撤销台湾无菌制药商展旺生技[size=18.6667px](Saviorliftec)的许可证2018年5月22日

根据EMA，本声明的[size=18.6667px]不符合规定的范围仅限于被认为对公众健康非关键的医药产品。检查发现了与美罗培南和美罗培南/碳酸钠共无菌混粉有关的一个关键缺陷。这一缺陷源于缺乏有关无菌处理的技术知识，其中包括设备的高压灭菌柜和干热杀菌柜、VHP装载模式设计和应用不足、培养基模拟灌装和环境监测等因素。

由于违反gmp规定，EMA有根据国家主管部门的决定，签发一份不符合规定的声明和有限的gmp证书，以允许继续生产和测试被认为是医疗关键的无菌原料药，或确保供应的连续性。在这一声明有效期间，非关键产品将不能提供给欧盟市场。然而，不会召回已经发布的产品。

syhorchid

了解一下

青山依旧在

不是美国佬打压台湾吧