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