摘要
对于药品原辅料供应商进行资质审查和现场审计是关系到药品质量稳定的重要环节,目前,供应商现场审计中存在着种种风险问题亟待解决。站在质量风险管理的角度上,探讨如何识别和评价现场审计的质量风险,运用风险管理科学方法有效控制这些风险,将会提高现场审计的质量,为药品生产安全有效、质量稳定提供有力保障。
The qualification examination and onsite audit for pharmaceutical raw materials suppliers are important procedure for ensuring the stability of drug quality. Currently, there are some problems which are needed to solve in urgency existed in onsite audit for suppliers. From view point of risk management, how to identify and assess the quality risk in onsite audit was discussed in this article. Using risk management method to efficiently control these risks will raise the quality of onsite audit and provide solid insurance for safety of drug production and stability of drug quality.
出处
《医药工程设计》
2013年第5期33-36,共4页
Pharmaceutical Engineering Design
关键词
质量风险管理
药品
现场审计
quality risk management
drug
onsite audit
