NSF International’s wholly owned China laboratory, located in Minhang district, Shanghai, China, operates as an NSF International Center of Excellence for extractables and leachables testing for a variety of container closure systems, bioprocessing equipment and drug delivery devices. Our extractables and leachables (E&L) programs are designed to meet each client’s unique requirements as well as satisfying applicable regulatory requirements, including CFDA, FDA, EMEA. You can rely on our ability to solve complex problems and provide superior methods development and validation to ensure a successful submission.
NSF中国实验室位于中国上海市闵行区，作为NSF International 卓越技术中心亚洲分部，是NSF International 在中国的全资子公司。中国实验室主要对各种药品包装、化学和生物制剂以及医疗设备提供提取物与浸出物的研究检测服务。NSF 中国实验室提取物与浸出物研究（E&L）项目旨在帮助国内制药企业申报CFDA，FDA，EMEA的相关法规要求以及客户的独特需求。客户不仅可以依靠我们解决复杂的问题，还能得到优良的方法开发和验证，确保药政申请获得成功。
Extractables and Leachables Testing on Pharmaceutical Packaging and Drug 药品包装材料与药物相容性研究服务
Provide controlled extraction testing according to the composition of pharmaceutical packaging components, contact method and conditions, etc.
Conduct potential risk assessment for possible extractables to determine the target leachables
Determine testing method based on leachables and build up specific methodology data
Conduct migration testing on substances related to drug products
Conduct toxicological evaluation on leachables from drug products
2Excipient Certification 辅料认证
NSF offers the only excipient GMP certification program accredited by the American National Standards Institute (ANSI). Third-party certification audits are based on NSF/IPEC/ANSI 363: Good Manufacturing Practices(GMP) for Pharmaceutical Excipients. NSF’s expertise in standards development and certification helps excipient manufacturers globally build credibility and save time and money through certification. NSF's excipient certification program (ECP) demonstrates conformance with the NSF/IPEC/ANSI 363 standard for pharmaceutical excipients GMPs. It is a mark of quality which gives the excipient buyer (wholesaler or pharmaceutical company) confidence in their supplier. The NSF mark provides assurance to pharmaceutical manufacturers that their excipients are being manufactured to appropriate GMPs. This facilitates compliance with both U.S. Food and Drug Administration Safety and Innovation Act (FDASIA) and Europe’s Falsified Medicines Directive (FMD), which require risk assessments and appropriate GMPs for excipients.