美国NSF International公司
发布日期:2018年2月26日
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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。

 
1
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.

    根据药品包装组件的组成,接触方式和条件等信息进行强制提取测试

  • Conduct potential risk assessment for possible extractables to determine the target leachables

      对可提取物进行潜在风险评估以明确目标浸出物

  • Determine testing method based on leachables and build up specific methodology data

      根据浸出物选择测试方法,并建立详细的方法学数据

  • Conduct migration testing on substances related to drug products

      对药品进行相关物质的迁移测试

  • Conduct toxicological evaluation on leachables from drug products

     对迁移出的相关物质做毒理学评估

 

2
Excipient 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.

NSF提供唯一经美国国家标准学会 (ANSI) 认可的辅料GMP认证计划。第三方认证审核根据 NSF/IPEC/ANSI 363:药用辅料良好生产规范(GMP)展开。NSF在标准制定和认证方面拥有丰富的专业知识,可通过认证帮助全球辅料制造商树立信誉并节省时间和成本。 NSF 辅料认证计划 (ECP) 符合 NSF/IPEC/ANSI 363 标准对药用辅料 GMP 的要求。该计划是一种质量保证,能够让辅料买方(批发商或制药公司)信任其供应商。 NSF 标识为药品制造商提供保证,确保其辅料按照相应GMP 要求生产。 这有助于遵守美国食品和药物管理局(FDA)安全与创新法案(FDASIA)以及欧洲反伪造药品指令 (FMD),这些法规要求对辅料进行风险评估并按照相应 GMP 要求生产辅料。

官方网站:http://www.nsf.org.cn

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