制药企业药品生产中的纠正和预防措施

Corrective Action & Preventive Action in Drug Manufacturing

目的:介绍《药品生产质量管理规范》(GMP,2010年修订)中的纠正和预防措施,为制药企业更好地进行药品生产管理提供参考。方法:概述纠正和预防措施的概念、实施的意义、实施的流程及要点,分析实施的难点。结果与结论:纠正和预防措施是GMP管理中的重点之一,企业应当建立良好有效的纠正措施和预防措施系统,按照规定的几大流程处理不合格及缺陷项目,并将纠正措施和预防措施有效地结合起来,发挥最大效力,提升企业质量管理水平。

OBJECTIVE： To introduce corrective action ＆ preventive action stated in Good Manufacturing Practice （GMP, 2010 revision）, and to provide reference for the management of drug manufacturing. METHODS： The concepts of corrective action ＆ preventive action were interpreted as well as significance, flow and main point of its, and the difficulty of conduction of correc- tive action ＆ preventive action was analyzed. RESULTS ＆ CONCLUSIONS： Corrective action ＆ preventive action are one of the key points in the GMP management, so the enterprise should build favorable and effective corrective and preventive action system, dispose unqualified and defective items according to specified flow, and then can farthest improve quality management level in the enterprise by combining corrective and preventive action effectively.