浅谈在实施新修订《药品经营质量管理规范》中开展风险管理

How to Carry Out the Risk Management in the Implementation of the Newly Revised GSP Process

药品风险管理是指贯穿整个药品生命周期的风险评估、控制、沟通和审核的系统过程;药品经营企业作为药品经营质量风险管理主体,应该在实施新修订《药品经营质量管理规范》(GSP)全环节、全过程中运用风险管理的手段正确识别药品经营全环节中的风险,并对被识别的风险进行科学评估、并通过科学、有效的管控手段对被识别的风险进行消除或者规避、达到降低药品经营风险危害程度的目的,从而进一步规范经营行为确保药品在经营环节的质量安全,保障人民群众的用药安全、有效。

Drug risk management is a system refers to the process of risk assessment, through the whole life cycle of a drug control, communication and audit;Enterprise risk management as the executive body, should be implemented in the newly revised GSP link, the whole process using the methods of risk management to correctly identify pharmaceutical trading links in the risk point;And the identified risk point of scientific assessment, and through scientific, effective management means to be identified risks are eliminated, to reduce or avoid the damage degree of drug management risk, thus play a secur- ity role to take risk management methods of enterprises^implementation of the newly revised GSP, further standardize business practices to ensure the quality and safety of the drug business links, safeguard people＇ s safety, effective.