摘要
目的:探讨适合药品检验实验室新建净化空调系统验证的风险评估实施方案,供相关研究人员参考。方法:采用失效模式影响分析(FMEA),就风险的严重性、风险的可能性、风险的可检测性对可能影响实验或数据有效性的系统功能或部件进行风险评估。结果:建立的风险评估实施方案,可将风险优先级为中、高的风险降至可接受水平,同时未引入新的风险。通过风险评估,确认了后续4Q阶段所需采取的风险控制措施。结论:本文应用风险评估方法科学确定新建净化空调系统验证的范围和程度,从而达到优化验证过程的目的,提出的实施方案具有一定的指导和借鉴意义。
Objective:To introduce an implementation scheme of risk assessment of validation for new purified air-conditioning system which was suitable for the pharmaceutical quality control laboratories(QCLs).Methods:Failure mode impact analysis(FMEA)is used to assess the risk of system functions or components that may affect the validity of experiments or data in terms of the severity,probability and detectability of risks.Results:The established risk assessment implementation plan can reduce the risk with medium or high Risk Priority Number to an acceptable level without introducing new risks.Through the risk assessment,the risk control measures to be taken in the following 4Q stages are comfired.Conclusion:To optimize the process of validation,risk assessment method is used to scientifically determine the scope and degree of validation for new purified air-conditioning system in this paper.Hence,the scheme contained certain guidance and reference significance.
作者
李筱玲
黄泽愉
高咏莉
王晓炜
Li Xiaoling;Huang Zeyu;Gao Yongli;Wang Xiaowei(Shenzhen Key Laboratory of drug quality standards,Shenzhen Institute for Drug Control,Guangdong518057)
出处
《天津药学》
2021年第4期70-73,共4页
Tianjin Pharmacy
关键词
风险评估
药品检验实验室
净化空调系统
验证
实施方案
risk assessment
pharmaceutical quality control laboratories
purified air-conditioning system
validation
implementation scheme
