• 主题
高级搜索  >
历史搜索 清空历史
首页> 外文期刊>Science Research >Technology transfer a global perspective: Crux of the matter
【24h】

Technology transfer a global perspective: Crux of the matter

机译：技术转移的全球视野：关键问题

获取原文
           
页面导航
  • 摘要
  • 著录项
  • 相似文献
  • 相关主题

摘要

Technology transfer has become a key activity in the pharmaceutical manufacturing domain. The processes are developed in an R&D set up for the API or finished dosage forms and are transferred to another site in the same country or different geographic location. Due to changing business needs, technology transfer has become a global activity and opens up various opportunities for the professionals in pharmaceutical domain. The coordination of various linked activities like procurement, quality, production, health & safety of the personnel involved in manufacturing and export have become more vital. This article discuss about various aspects of technology transfer like outsourcing key raw materials, information security to protect the intellectual property, various development strategies for API development and most significantly the practical difficulties encountered during API technology transfer. It is also describing certain trouble shooting issues, which were resolved with the help of reaction mechanism & chemistry involved in processes and investigations made to arrive at appropriate CAPA. This article is also indicating simple laboratory techniques/ instruments, which could be adopted to support PAT initiatives. It is also describing examples of how certain process improvements were achieved due to trouble shooting in scale up trial batches.
机译：技术转让已成为制药生产领域的关键活动。这些过程是在针对API或最终剂型的研发中开发的，并转移到同一国家或不同地理位置的另一个站点。由于业务需求的变化，技术转让已成为一项全球性活动，并为制药领域的专业人员提供了各种机会。涉及生产和出口的人员的各种联系活动（如采购，质量，生产，健康与安全）的协调变得更加重要。本文讨论了技术转让的各个方面，例如外包关键原材料，保护知识产权的信息安全，API开发的各种开发策略以及最重要的是API技术转让过程中遇到的实际困难。它还描述了某些故障排除问题，这些问题已通过参与过程和研究的反应机理和化学手段得以解决，从而获得了适当的CAPA。本文还指出了可用于支持PAT计划的简单实验室技术/仪器。它还描述了一些示例，这些示例说明了由于按比例放大试验批次中的故障排除而如何实现某些过程改进。

著录项

相似文献

  • 外文文献
  • 中文文献
  • 专利
获取原文

客服邮箱：kefu@zhangqiaokeyan.com

京公网安备：11010802029741号 ICP备案号：京ICP备15016152号-6 六维联合信息科技 (北京) 有限公司©版权所有

  • 客服微信

  • 服务号