质量风险管理在药品经营质量管理规范实施中的作用

The Role of Quality Risk Management in the Implementation of GSP

对药品经营企业而言,应树立正确的质量风险管理意识,并借助恰当的管理工具构建相应的管理体系,从而对药品经营质量管理规范(GSP)实施过程中的质量风险进行有效管理。对此,本文介绍了质量风险管理的界定及其流程,并就药品经营企业实施GSP的意义、药品经营企业质量风险管理的主要程序以及质量风险管理在药品经营企业GSP实施过程中的作用展开了详细论述。希望可提供有效参考给药品经营企业,便于其在GSP实施过程中进行质量风险管理。

For pharmaceutical enterprises,they should establish a correct awareness of quality risk management and build a corresponding management system with the help of appropriate management tools,so as to effectively manage the quality risk in the implementation of GSP.In this regard,this paper introduces the definition and process of quality risk management,and discusses in detail the significance of implementing GSP in pharmaceutical enterprises,the main procedures of quality risk management in pharmaceutical enterprises,and the role of quality risk management in the implementation of GSP in pharmaceutical enterprises.It is hoped that it can provide effective reference for drug trading enterprises to facilitate their quality risk management during the implementation of GSP.