良好的制药企业偏差管理

Good deviation management in pharmaceutical enterprise

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。

The common deviation defciencies 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, including the requirement of deviation report, the procedure for deviation investigation, the determination of root cause, the disposal of batch products or materials involved, the assessment of quality risk for the deviation, the formulation of corrective action and preventive action （CAPA）, the confrmation and approval of the investigation fndings, the implementation of CAPA track and the review of its efectiveness.