WuXi Biologics在经过五天的检查后, 获得土耳其GMP对三家中国设施的批准。 WuXi Biologics earns Turkey’s GMP approval for three China facilities, passing a five-day inspection.

武西生物公司获得了土耳其TITCK对其中国无锡的三家工厂的GMP认证,这标志着土耳其监管机构首次进行此类检查. WuXi Biologics has earned GMP certification from Turkey’s TITCK for three of its Wuxi, China facilities—MFG1, MFG2, and DP5, marking the first such inspection by Turkey’s regulatory body. 这些设施对两个单克隆抗体生物学进行了为期五天的现场审查,表明它们遵守了国际质量标准。 The facilities passed a five-day on-site review of two monoclonal antibody biologics, demonstrating compliance with international quality standards. 这项成就使WuXi生物logic公司44次监管检查的记录,包括林业发展局和EMA的22次检查,以及林业发展局业前检查100%的通过率增加。 This achievement adds to WuXi Biologics’ track record of 44 regulatory inspections, including 22 by the FDA and EMA, and a 100% pass rate on FDA Pre-License Inspections. 该公司在全球经营16个经全球监测方案认证的设施,并成功地完成了国际客户的1 700多项全球监测方案审计,包括欧盟合格人员200多项审计。 The company operates 16 GMP-certified facilities globally and has successfully completed over 1,700 GMP audits by international clients, including more than 200 by EU Qualified Persons.