| FDA国外cGMP检查对中国制药企业的影响分析 |
| |
| 引用本文： | 韩文涛,张铁军,王艳稳. FDA国外cGMP检查对中国制药企业的影响分析[J]. 中国药事, 2011, 25(11): 1140-1142,1147 |
| |
| 作者姓名： | 韩文涛 张铁军 王艳稳 |
| |
| 作者单位： | 1. 华北制药华胜有限公司,石家庄,052160
2. 华北制药股份有限公司 |
| |
| 摘 要： | 目的为中国制药企业进入美国市场找出一条合适的途径。方法查阅近年来相关文献,对FDA国外cGMP检查的现状进行分析总结,提出中国企业接受FDA检查的应对措施。结果与结论面对FDA日益严格的GMP监管,中国制药企业只有严格按照FDA cGMP规范指导生产,才能通过FDA现场检查,进入美国市场。
|
| 关 键 词： | FDA cGMP 中国制药企业 |
Impact of FDA Foreign cGMP Compliance Inspection on Chinese Pharmaceutical Manufactures |
| |
| Han Wentao,Zhang Tiejun,Wang Yanwen. Impact of FDA Foreign cGMP Compliance Inspection on Chinese Pharmaceutical Manufactures[J]. Chinese Pharmaceutical Affairs, 2011, 25(11): 1140-1142,1147 |
| |
| Authors: | Han Wentao Zhang Tiejun Wang Yanwen |
| |
| Affiliation: | Han Wentao,Zhang Tiejun1 and Wang Yanwen(North China Pharmaceutical Huasheng Co.,Ltd.,Shijiazhuang 052160,1North China Pharmaceutical Co.,Ltd.) |
| |
| Abstract: | Objective To bring forward an appropriate way to enter U.S.market for Chinese pharmaceutical manufactures.Methods The status of FDA foreign cGMP compliance inspection is analyzed by reviewing recent year papers,and the relative actions about FDA cGMP compliance inspection are brought forward for Chinese pharmaceutical manufactures.Results and Conclusion Chinese pharmaceutical manufactures have to instruct production strictly according to FDA cGMP,and then may pass FDA site inspection and enter U.S.market. |
| |
| Keywords: | FDA cGMP Chinese pharmaceutical manufactures |
| 本文献已被 CNKI 维普 万方数据 等数据库收录！ |
|
