| 药品GMP认证现场检查管理探讨 |
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| 引用本文： | 黄怀元.药品GMP认证现场检查管理探讨[J].中国药事,2009,23(1):94-95. |
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| 作者姓名： | 黄怀元 |
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| 作者单位： | 福建省食品药品监督管理局,福州,350003 |
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| 摘 要： | 目的 探讨药品GMP认证现场检查的规范管理，实现科学监管。方法 从GMP现场检查的定位，现场检查的目的，现场捡查的准备，现场检查员的选派，建立严谨的现场检查规则，做出客观公正的判断等方面，提高GMP的现场检查质量。结果 科学的管理必定有公正的现场检查。结论 规范的现场检查才能保障实施GMP的质量。
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| 关 键 词： | GMP认证检查 科学 公正 规范 |
Discussion on the Administration of Drug Manufacturing Spot Inspection for GMP Compliance |
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| Huang Huaiyuan.Discussion on the Administration of Drug Manufacturing Spot Inspection for GMP Compliance[J].Chinese Pharmaceutical Affairs,2009,23(1):94-95. |
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| Authors: | Huang Huaiyuan |
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| Institution: | Huang Huaiyuan (Fujian Food and Drug Administration, Fuzhou350003) |
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| Abstract: | Objective Discussion on the standard administration of drug manufacturing spot inspection for GMP compliance in order to perform a scientific supervision.Methods Adopting a risk-managemen evaluation method with a human-emphasize to improve the quality of both spot inspection and consequent GMP implementations.Results Scientific administration will definitely lead to a equitable spot inspection.Conclusions Standard spot inspection will guarantee a good quality of GMP execution. |
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| Keywords: | GMP inspection scientific equitable standard |
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