风险管理在药品批发企业冷链药品质量管理中的实践

冷链药品是一类对温度高度敏感的药品,储存或运输过程中对温度控制不当,极易造成不良事件或经济损失.药品批发企业是影响冷链药品质量的关键环节,2013年版《药品经营质量管理规范》对冷链药品质量管理十分重视,明确提出冷链物流管理的要求.本企业在实施2013年版《药品经营质量管理规范》过程中,运用风险管理的理论和方法,通过分析原有质量管理体系存在的风险因素,从提高风险管理意识、完善质量管理体系文件、改善硬件条件、实施验证管理等方面完善了冷链药品风险管理体系,能够对影响药品质量的风险因素进行有效控制,从而将可能造成药品质量的风险控制在最低限度,最大限度地保证药品质量.

Practice of rish management in quality management for cold chain drug of medicine wholesale enterprise

Cold chain drugs is a kind of drugs having strong sensitivity to emperature,temperature control undeserved during storage or transport of drugs is extremely easy to cause adverse events or economic loss.Medicine wholesale en- terprise is the key link of influencing the quality of the cold chain drugs,Drug operation quality management rules of 2013 edition attaches great importance to the cold chain pharmaceutical quality management,and clearly puts forward the requirement of cold chain logistics management.The enterprise uses the theory and methods of risk management in the implementation process of Drug operation quality management rules of 2013 edition,through the analysis of the risk factors existing in the original quality management system,improves the cold chain drugs risk management system from the aspects of improving risk management awareness,improving the quality management system documents,improving the hardware condition,implementing the verification management and so on,can effectively control the risk factors that affect the drug quality,so to control the drug quality risk may result in a minimum,furthest ensures drug quality.