FDA 产品质量的风险评估原则(翻译).pptVIP

* I say “re-link” because it is a given that the links were there historically. In general, there was a valid health and safety reason for each of the product GMPs. Promulgations of the standards was based on an analytic-deliberative process in risk assessment. What has happen is a loss of prioritized relevance to how drugs are manufactured today and with what we know about patient risks, today. * * * How well does risk analysis do in a democratic society? There are lots of risks “out there” and limited resources with which to manage them. There is simply no way to drive all risks to zer