摘要
目的探讨危害分析和关键控制点风险分析工具在原料药研发项目管理中的应用。方法原料药研发项目分为启动、规划、执行、控制、收尾阶段,结合危害分析和关键控制点的理论依据与实施,逐步评估原料药研发项目中各阶段的风险点,针对风险点提出风险控制措施。结果总结了原料药项目各个阶段中的风险点,并针对风险点提出了风险控制措施。结论危害分析和关键控制点风险分析工具有助于对原料药研发项目的风险评估与控制。
Objective To investigate the application of hazard analysis and critical control point(HACCP)risk analysis tools in the management of active pharmaceutical ingredient(API)research and development projects.Methods The API research and development projects were divided into initiation,planning,execution,control and closing stages.Based on the theory and implementation of HACCP,the risk points in each stage of API research and development projects were assessed step by step,and risk control measures were put forward according to risk points.Results The risk points in each stage of API projects were summarized,and the risk control measures were put forward according to the risk points.Conclusion HACCP risk analysis tools are helpful for risk assessment and control of API research and development projects.
作者
黄娟
杨悦
HUANG Juan;YANG Yue(Shenyang Pharmaceutical University,Shenyang,Liaoning,China 110016;Huabei Pharmaceutical Group Xiantai Pharmaceutical Co.,Ltd., Shijiazhuang,Hebei,China 050021)
出处
《中国药业》
CAS
2019年第9期78-81,共4页
China Pharmaceuticals
关键词
危害分析和关键控制点
项目管理
原料药研发
风险管理
hazard analysis and critical control point
project management
active pharmaceutical ingredient research and development
risk management
