期刊文献+

ISO 9000族标准、GMP与医院制剂 被引量:4

The ISO 9000 family of International Standards 、GMP and Hospital Preparations
下载PDF
导出
摘要 目的:国际标准化组织制定的1SO9000族标准(1994年修订版)是一个完整的、先进的质量管理和质量保证标准,是一套国际统一的管理标准,它适用于GMP和医院制剂。方法:本文着重介绍了ISO9000族标准,探讨了ISO9000族标准与GMP和医院制剂的关系。结果:GMP和医院制剂许可证制度是药品生产或制备中不可缺少的,是药品质量监督管理的重要内容,但作为体系与ISO9000族比较是不完善的,)结论:GMP与ISO9000族标准溶为一体,更多的中国制药企业的产品将走向国际市场,医院制剂室的药品将更安全、更有效。 AIM : The ISO 9000 family of international Standards( 1994 edition) prepared by international Organization forStandardization is a whole set of advanced standards of quality management and quality assurance. As a set of worldly unifiedstandards of management , it is appropriate for GMP and hospital preparations. METHODS : This article introduces emphaticallythe ISO 9000 family of international Standards and discusses the relationship among ISO 9000 family and GMP and hospitalpreparations. RESULTS: GMP and the hospital preparations licence system are both necessary for the drug production andpreparation , and they are important contents of the drug quality supervision. But compared with ISO 9000 family , they are not aperfect system. CONCLUSION: GMP and ISO 9000 family of international Standards are supplementary to each other. Moreand more products of Chinese pharmaceutical manufactories will take their places on the international market; and the drugsfrom hospital preparations rooms will be safer and more effective.
出处 《中国药房》 CAS CSCD 1999年第2期53-54,共2页 China Pharmacy
关键词 质量管理 ISO9000族 GMP 药品质量 医院制剂 quality management ,ISO 9000 family, GMP drug quality, hospital preparations
  • 引文网络
  • 相关文献

参考文献2

  • 1刘爱基 李虹.质量保证标准的理解与实施,第1版[M].北京:中国标准出版社,1996.4. 被引量:1
  • 2王以铭主编..最新中外质量认证工作全书[M].北京:中国计量出版社,1997:1602.

同被引文献5

引证文献4

二级引证文献2

相关主题

;
使用帮助 返回顶部