本帖最后由 beiwei5du 于 2018-7-5 09:53 编辑
所以这个主要职责也在于企业，这种方式也是基于不阻碍限制技术改进的方式吧。
针对于高风险的产品共线，检查员也会有基本的重点核查吧，所以企业也必须考虑到法规监管的风险。
我觉得主要还是监管理念不同后考虑权衡后的一个选择。这个可以参考一下：
Word to the Wise (Drug Manufacturer): Don’t Use Your Manufacturing Equipment to Produce Toxic, Non-Pharmaceutical Products
This leads to some inevitable questions, such as: whether FDA would allege a violation of the FDCA if only the first two conditions had occurred but not the third, or if only the first condition had occurred. In other words, does the FDA believe that the FDCA forbids the manufacture of non-pharmaceuticals on pharmaceutical equipment regardless of whether or not the non-pharmaceuticals manufactured are toxic to humans? If so, what is the regulatory basis for this claim? One also has to wonder how FDA would respond if ChemRite provided the agency with data that showed in a validated way not only that their dual use manufacturing equipment could be thoroughly cleaned without leaving a residue, but that in fact the equipment had been thoroughly cleaned prior to each of the lots of drug product manufactured on this equipment, without leaving any residue from the non-pharmaceutical manufacturing.
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发表于 2018-7-4 23:38:03
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