5家中国药企通过欧盟GMP远程检查！

近日，欧盟EudraGMDP发布了无锡药明生物技术有限公司的GMP符合性证书，该证书通过远程检查发布，检查日期为2021年3月2日。

The competent authority of Ireland confirms the following:

检查机构：爱尔兰药监局

The manufacturer :WuXi Biologics Co., Ltd

生产企业：无锡药明生物技术股份有限公司

Clarifying remarks (for public users) :

说明

1.3.1.2 relates to manufacture ofbiological active substance using mammalian cell culture, its isolation /purification and formulation as a low bioburden bulk intermediate. Thisinspection was conducted via the Distant Assessment process. The scope of thedistant assessment was limited to the following buildings at the site:Buildings 27 / 32 / 36 (warehouses in which raw materials, excipients andconsumables were stored), Building 31 (manufacturing operations) and Building24 (quality control testing operations). The HPRA does not routinely issue hardcopies of GMP certificates. Authenticity of GMP certification may be verifiedon the EudraGMDP database.

1.3.1.2涉及使用哺乳动物细胞培养的生物活性物质的生产、分离/纯化和作为低生物负荷散装中间体的配制。本检查通过远程评估进行。远程评估的范围仅限于工厂的以下建筑物：27 / 32 / 36号建筑(存放原料、辅料和耗材的仓库)、31号建筑(生产操作)和24号建筑(QC检验操作)。HPRA通常不会发放纸质GMP证书。GMP认证的真实性可通过EudraGMDP数据库进行验证。

截至目前为止，已有诺和诺德（中国）制药有限公司、浙江京新制药有限公司、天津天士力药业有限公司（天津市北辰区汀江西路3号工厂和天津市北辰区普吉河东路2号工厂）及无锡药明生物技术有限公司通过了欧盟GMP远程检查。