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药品实时放行检测简介 被引量:3

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摘要 通过对药品实时放行检测的定义和相关概念的阐述,浅析了其在实施过程中的获益和存在问题。
作者 杜雯君 梁毅
出处 《机电信息》 2012年第8期23-26,共4页
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参考文献7

  • 1王智民,张启伟.美国FDA产业指南:创新的药物开发、生产和质量保障框架体系——PAT[J].中国中药杂志,2009,34(24):3304-3309. 被引量:11
  • 2Line Lundsberg-Nielsen. ing [EB/OL]. http ://www. rct=j&q=Real% 20Time% Real Time Release Test- google, com. hk/url?sa=t& 20Release% 20Testing% 20nne&source=web&cd=l&ved=OCCcOFjAA&url=http % 3A%2F%2Fwww. industry, siemens, com%2Fverticals% 2Fglobal%2Fen%2Fpharma-industries%2FDocuments% 2Fpat-event-sl ides %2F4 real-time-release-test ing. pdf&ei=vo8NT900E-KOiAeKx730BO&usg=AFQjCN EhfPVZYtaYCXwUBMNI2G3GO4h8cg. pdf.
  • 3FDA, Guidance for Industry:PAT-A Framework for Innovative Pharmaceutical Development, Manufacturing, and Ouality Assurance (Rockville, MD, Sept ember 2004).
  • 4EMA, Guideline on Real Time Release Testing (formerly Guideline on Parametric Release), draft, February 2010.
  • 5ICH, Quality Implementation Working Group on Q8, Q0, and QIO Questions and Answers (Nov. 11, 2010) http://www, ich. org/.
  • 6Angie Drakulich. Real Time Release Testing [EB/OL]. http://pharmtech, findpharma, com/phar- mtech/article/articleDetail, jsp?id=707051.
  • 7梁毅.新版GMP教程[M].北京:中国医药科技出版社,2011.9:178.

二级参考文献4

  • 1.Guidance for industry and FDA staff,general principles of softwarevalidation[]..
  • 2.FDA/ORA Compliance Policy Guide,Sec.130.300,FDA accessto results of quality assurance program audits and inspections (CPG7151.02)[]..
  • 3.FDA guidance for industry,Comparability protocols chemistry,manufacturing,and controls information[]..2003
  • 4.FDA field management directive 135[]..

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