杨家爱,曹天海.哥伦比亚食品和药品管理机构的GMP认证简介及流程[J].中国药事,2018,32(12):1660-1662 |
哥伦比亚食品和药品管理机构的GMP认证简介及流程 |
A Brief Introduction and Procedures of GMP Certification by INVIMA of Columbia |
修订日期:2016-12-09 |
DOI:10.16153/j.1002-7777.2018.12.013 |
中文关键词: 哥伦比亚 食品和药品管理机构 GMP |
英文关键词: Columbia INVIMA GMP |
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中文摘要: |
目的:介绍哥伦比亚共和国食品和药品管理机构(INVIMA)的GMP认证要求及流程。方法:通过文献检索,结合参加INVIMA认证的实际经验,对相关信息进行总结。结果与结论:哥伦比亚处于发展中国家的中上水平,我国已有多家公司通过其GMP认证。相信通过不断努力,我国药企一定会以高质量的药品在哥伦比亚和南美市场占有一席之地,并取得良好的经济效益。 |
英文摘要: |
Objective:To introduce requirements and procedures of GMP certification by INVIMA of Columbia. Methods:By literature retrieval, the related information about INVIMA GMP certification was summarized through combining with our practical experiences. Results and Conclusion:Columbia is above average among the developing countries, and a number of companies in China have passed the INVIMA GMP certification. We believe that the Chinese pharmaceutical companies could occupy parts of the markets in Columbia and South America and achieve good economical benefits. |
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