摘要
目的:介绍制药企业实施偏差管理的方法与必要性。方法:结合新版MHRA超标/超常调查指南以及ISPE-PDA根本原因分析工具,对制药企业偏差管理的实施进行阐述。结果与结论:建立良好的偏差管理制度,是制药企业自身发展与提升所必须具备的能力。
Objective:To introduce the methods and necessity for implementing deviation management in pharmaceutical companies.Methods:In combination with the new version of MHRA out of specification&out of trend investigations and ISPE-PDA root cause analysis tool,the implementation of deviation management in pharmaceutical companies is comprehensively explained.Results&Conclusion:The establishment of a good deviation management system is a necessary ability for pharmaceutical companies to develop and improve themselves.
作者
郭锋
甄全伟
戴海潮
GUO Feng;ZHEN Quanwei;DAI Haichao(Yangtze River Pharmaceutical Group Co.,Ltd.,Taizhou 225300,China)
出处
《上海医药》
CAS
2021年第13期51-54,共4页
Shanghai Medical & Pharmaceutical Journal
关键词
偏差
根本原因分析
风险评估
纠正措施与预防措施
deviation
root cause analysis
risk assessment
corrective action and preventive action
