摘 要 介绍制药企业常见的偏差管理缺陷，并分别从制药企业和药品监管的角度，分析导致这些缺陷的原因。对如何建立一个良好的制药企业偏差管理流程进行阐述，包括对偏差报告的要求、偏差的调查程序、根本原因的确定、涉及批产品或物料的处置、偏差质量风险评估、整改措施和预防措施(CAPA)制定、调查结论的确认和批准、CAPA实施的跟踪及有效性回顾。

    关键词 偏差 评估 整改措施和预防措施

    中图分类号：F425 文献标志码：C 文章编号：1006-1533(2018)09-0047-04

    Good deviation management in pharmaceutical enterprise

    TAN Jianxin， DING Licheng， FU Qiuyan*

    (Shanghai Center of Drug Evaluation and Inspection， Shanghai 201203， China)

    ABSTRACT The common deviation deficiencies in pharmaceutical enterprises were introduced and the causes of these deficiencies were analyzed from the working experience in pharmaceutical industry and the perspective of drug regulation inspector. How to set up a good deviation management process in pharmaceutical enterprises was also described ......