摘要
目的规范药品现场检查工作。方法对检查员在药品现场检查中的基本要求进行总结,并归纳为十三要及十三戒。结果与结论为检查员改进检查方法及技巧、规范药品现场检查工作、提高工作质量提供有益借鉴。
Objective To regulate the pharmaceutical on-site inspection.Methods This article summarizes the basic requirements for pharmaceutical on-site inspection.The thirteen "Dos" and "DON'Ts" proposed in this article were expected.Results and Conclusion To provide a guideline for inspectors to improve tactics and techniques adopted in inspection,and therefore further regulate and enhance the quality of pharmaceutical on-site inspection.
出处
《中国药事》
CAS
2011年第5期451-452,472,共3页
Chinese Pharmaceutical Affairs
关键词
药品认证
现场检查
要戒
certification of drug
on-site inspection
"Dos" and "DON'Ts"