摘要
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 article discusses about distinguishing and estimating the risk of quality based on the quality risk management. If the auditors can use the methods of risk management to control these risks, it will be beneficial to the on-site audit.
关键词
质量风险管理
药品
现场审计
quality risk management
medicine
on-site audit
