车间正在进行一个改造项目，一班领导雄心勃勃，提出了口号“全面评估，严格控制，保证零风险生产”
口号喊得很响。
不干咱的事，咱只能私下里“呵呵”！
啥事情能保证“零风险”啊
睡在床上还能赶上地震呢
最近也在翻译，正在看到了这一点论述：
The International Conference on Harmonisation (ICH) in their Q9 Quality Risk Management document (Reference 28,Section 15.1) state “The manufacturing and use of a drug product, including its components, necessarily entail some degree of risk.”
ICH Q9质量风险管理文件（15.1部分， 28条）说：药品的生产和使用，包括它的组件，有必要存在一定程度的风险。“
The FDA also has acknowledged this fact in the Report to the FDA Commissioner from the Task Force on Risk Management, May 1999, “Although medicinal products are required to be safe, safety does not mean zero risk. A safe product is one that has reasonable risks, given the magnitude of the benefits expected and the alternative available.”
FDA也认识到了这个情况，在风险管理专门小组递交给FDA委员的报告，1999年5月，“尽管要求医药产品安全，但安全并不意味这零风险。一个安全的产品是含有合理风险的产品，考虑到它预期的利益的重要和可选择性”。
In addition, the EMEA acknowledged this fact in their Action Plan to Further Progress the European Risk Management Strategy, 4 May 2005 (Reference 10, Section 15.1), “However, in view of the increasing and justified demands from patients and the general public for an adequate protection of public health, resulting in the availability of safe and effective medicines, it is important to re-emphasise that the concept of “zero risk” does not apply to medicinal products. The licensing of medicinal products needs to be assessed in the context of the benefit/risk balance concept, whereby demonstrated benefits must outweigh known risks, leading to a favourable benefit/risk ratio and the resulting marketing authorisation.”
另外，EMEA也认识到了这个情况，在深入推进欧洲的风险管理策略的执行计划中，2005年5月4日（15.1部分，10条）“然而，考虑到与日俱增且合理的来自病人和要求足够公共健康保护的公 众的需求，导致安全和有效药物的可用性，再强调一下零风险的理念不适用于医药产品是很重要的”。药品许可证的发放需要在利益/风险平衡理念的背景下进行评估，以此来证明利益一定要高于风险，导致有利的利益/风险比例和市场批准。
“零风险”不适用于医药行业！！
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发表于 2014-10-27 10:07:23
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