医院制剂产品GMP验证初探
医院,,医院制剂；验证；GMP；质量保证,1验证的定义,2验证的意义,3验证的组织实施,4验证过程中值得注意的几个问题,参考文献：
摘要：目的：提高医院制剂室产品的质量。方法：本文通过对验证的内涵、意义、具体做法及验证的组织实施等讨论，将所得数据进行统计学处理。结果：说明验证是药品生产中GMP的基石。结论：GMP是提高制剂产品质量的重要保证。关键词：医院制剂；验证；GMP；质量保证
Validation the GMP of Hospital Medicinal Drugs Preparation
FENG Yun-qin，TANG Pin-shan
(The TCM Hospital of Sanshui District Foshan City, Guangdong Foshan 528100, China)
Abstract: Objective: Improving the quality of medicinal drugs preparation in the hospital. Method:By discussing the connotation, sense, material modusoperandi and actualization of validation, this paper processes the gained data in a statistical way.Result: validation is the base of GMP in medicine producing. Conclusion: GMP is an important guarantee to improve the quality of medicinal drugs preparation.
Key words: Hospital medicinal drugs preparation；Validation；GMP；Quality guarantee
为了保证供给使用的药品安全和有效，国家医药总局、各省卫生厅先后颁布了《医院制剂规范》、《检验标准》、《中华人民共和国药典》《药品管理法》来规范和约束各个生产企业的产品质量 ......
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