【作者】 梁毅； 黄雪；

【Author】 LIANG Yi;ZHOU Wen yu;China Pharmaceutical University;

【机构】 中国药科大学国际医药商学院；

【摘要】 目的:为药品生产企业设备故障风险管理提供可行的分析工具,提高设备的GMP管理水平。方法:根据ICH-Q9就提出的质量风险管理的理念,选用运用故障树分析(FTA)工具,以药品生产企业常用的制药设备-干燥箱为例,应用因果分析图对其的故障风险进行识别。结果:根据评估,设备所处环境和能源供应情况是设备发生故障的最重要的因素,设备故障帕累托图的分析结果也印证了FTA评估结果的准确性。结论:新版GMP要求进行"设备的预防性维护",以确保设备在运行过程中处于无故障的正常运转状态。以往制药企业在进行设备故障管理时,大多凭经验,防范措施也基本为事后处置。而科学应用FTA工具,能对设备故障发生的主要因素进行准确分析,从而减少设备故障的发生,达到GMP要求。更多还原

【Abstract】 Objective:This paper provides analysis tools available for equipment failure risk management,provides a reference for the risk management of pharmaceutical production enterprises,and improves the management level of drug quality risk.Method:According to the ICH-Q9 quality risk management idea,by use of fault tree analysis(FTA) tools,to pharmaceutical production enterprises commonly used pharmaceutical equipment--drying box as an example,application of the chart of causal analysis of failure risk for the drying box identification.Results:According to the FTA risk assessment,environment and energy supply of equipment failure plays the most important role,so that the other conditions ensured,mainly to reduce the occurrence of this two kinds of accidents.But the accuracy of equipment fault analysis Pareto graph results also confirmed that the FTA evaluation.Discussion In the past,many pharmaceutical producing enterprises in equipment fault management,are mosdy by experience,preventive measures are basically after disposal.The new version of GMP requires that the drug production enterprises must carry out " preventive maintenance for equipment",to ensure that the equipment in normal operation condition without maintenance during operation.To achieve this target,we must have scientific management tools,in terms of equipment failure risk analysis,the FTA tool is a feasible tool.更多还原