欧盟发布QP问答：中控不合格，能不能放行？

近日，欧盟药监局发布关于质量受权人的问答文件，其中谈到药品不符合中控标准放行措施，翻译如下：In the context of handling unexpected deviations, what is included in the scope of registered specifications for medicinal products?在处理意外偏差的情况下，医药产品注册标准的范围包括哪些内容？ In order to satisfy the criteria in Annex 16 section 3 for handling unexpected deviations, all registered specifications for active substances, excipients, packaging materials and medicinal products must be met.为了满足附件16第3节处理意外偏差的标准，所有活性物质，辅料，包装材料和产品必须符合注册标准。 Registered specifications for medicinal products include in-process, bulk and finished product specifications which have been included in the MA application.医药产品注册标准 ………………………………