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Position: Home > Articles > Comparison of current good manufacturing practices(GMP) for veterinary and human drugs Animal Husbandry & Veterinary Medicine 2017 (12) 134-139

我国现行兽药GMP与药品GMP的比较

作  者:
陈莎莎;安洪泽;张骊
关键词:
兽药;药品;GMP;差异比较
摘  要:
现行兽药GMP实施多年来,其技术标准已逐渐不能满足当前管理工作的需要。通过对我国现行兽药GMP与药品GMP(2010年修订)的框架结构、人员、洁净级别设置、质量管理、文件管理等主要方面进行差异比较,并在此基础上提出了对我国兽药GMP的改进建议。
译  名:
Comparison of current good manufacturing practices(GMP) for veterinary and human drugs
作  者:
CHEN Shasha;AN Hongze;ZHANG Li;China Institute of Veterinary Drug Control;
单  位:
China Institute of Veterinary Drug Control
关键词:
veterinary drug;;human drug;;GMP;;comparison
摘  要:
The standards of current veterinary drug GMP has gradually been unable to meet the needs of the current management. Thedifferences between current veterinary drug GMP and human drug GMP(revised 2010) were compared in order to give some suggestions onveterinary drug GMP. In this review, the differences in framework, personnel, clean air classification, quality management and documenta-tion management were compared.

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