我国质量风险管理在GSP实施中的应用

Application of Quality Risk Management in the Implementation of GSP in China

目的:为药品经营企业在《药品经营质量管理规范》(GSP)实施中的质量风险管理提供参考。方法:采用风险评估、风险控制、风险审核的步骤和方法,运用风险排列和过滤工具,结合GSP实施中进货环节的实例对质量风险管理进行探析。结果与结论:药品经营企业需要树立正确的质量风险管理意识,运用恰当的管理工具,建立管理体系,以有效管理GSP实施中的质量风险。

OBJECTIVE： To provide reference for quality risk management in the implementation of GSP of drug trading enter- prises. METHODS： According to the step and methods of risk assessment and risk control as well as risk review, the tools of risk ranking and filtering were used to study quality risk management by the example of the implementation of GSP in drug purchase links. RESULTS ＆ CONCLUSIONS： The drug trading enterprises should have the right consciousness of quality risk management and use the reasonable tools of quality risk management to manage the quality risk during the implementation of GSP efficiently by building the system of quality risk management.