郭锋 甄全伟 戴海潮

    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。

    关键词 偏差 根本原因分析 风险评估 纠正措施与预防措施

    中圖分类号：F406.2； R951 文献标志码：C 文章编号：1006-1533(2021)13-0051-04

    Implementation of deviation management in pharmaceutical enterprises

    GUO Feng， ZHEN Quanwei， DAI Haichao

    (Yangtze River Pharmaceutical Group Co.， Ltd.， Taizhou 225300， China)

    ABSTRACT 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. ......