从COS搁置谈原料药生产企业如何通过国际认证现场检查

Discussion on How to Succeed in the On-site Inspection of International Certification for Drug Substances Manufacturers in View of the Suspension of COS

目的:为我国原料药出口生产企业顺利通过国际认证现场检查提供借鉴。方法:跟踪国外原料药进出口相关法规变化,分析我国原料药生产企业欧洲药典适用性证书(COS)被搁置的原因并提出建议。结果与结论:生产现场存在与欧盟《药品生产质量管理规范》(GMP)要求不符的重大缺陷是导致COS被搁置的主要原因,提高原料药生产过程的GMP管理水平是企业顺利通过国际认证现场检查的关键所在。

OBJECTIVE： To provide reference for drug substances manufacturers to succeed in the on-site inspection of international certification. METHODS： The changes of regulations for import and export of drug substance in foreign countries were followed up. The reason why Certificate of Suitability to European Pharmacopoeia （COS） was suspended in drug substances manufacturers were analyzed then put forward some suggestions. RESULTS CONCLUSIONS： The most important reason for the suspension of COS is that there are critical deficiencies in the manufacturing site which is not in compliance with EU GMP. The improvement of GMP practice level is the key to drug substances manufacturers to pass the in-site inspection of international certification.