原料药生产商是否能向药监局自愿申请进行现场检查？ - 药群论坛

20150429 ECA新闻：原料药生产商是否能向药监局自愿申请进行现场检查？

Is it possible to ask the Authorities for a voluntaryInspection of an API Manufacturer?

a) whether a GMP certificate based on an inspection of anEU Inspectorate can liberate the Marketing Authorisation holder from itsresponsibility to audit and

是否通过EU现场检查获得一份EU GMP证书后，上市许可持有人可以免于审计责任

b) whether an API manufacturer can ask for an inspectionto receive an EU GMP certificate

是否原料药生产商可以申请进行现场 检查来获得一份EU GMP证书

Already in a Q&A from 2006, it is said thatinspection reports or GMP certificates issued by EEA "cannot fulfil thestatutory obligations of the manufacturing authorisation holder or therequirements of section 5.25 of the GMP Guide, but the results of inspections,may be used together with other supporting information in a risk-based approachby the manufacturer in establishing priorities for its own audit programme ofactive substance suppliers".

在2006年的问答中，已经明确了由EEA签发的检查报告或GMP证书“不能免除生产许可持有人的法定义务，或GMP指南第5.25部分所赋予的要求，但检查的结果可以与其它支持性信息一起，由生产商采用基于风险的方法来建立基自己对原料药生产商的优先顺序。”

Now, on the same Q&A website of the EMA,this question is answered again. Here it is clearly stated that "An inspectionof the active substance manufacturer by an EEA authority does not liberate a MAholder from this responsibility".

现在，EMA同样的问答中，该问题又重新进行了回答。这里清楚地说明了“EEA药监对原料药生产商的检查并不能免除上市许可持有人的职责。”

Although there is a provision for the competent authorityto carry out inspections of starting material manufacturers at the specificrequest of the manufacturer, there is "no guarantee that such a requestwill be fulfilled since competent authorities primarily use risk-basedprinciples to plan starting material inspections". So there is noobligation for the respective inspectorate to do so.

尽管药监也有条款规定相关药监可以在生产商的特定要求下对起始物料生产商进行检查，但“不会保证一定满足这样的要求，因为药监部门首先要使用基于风险的原则对起始物料检查制订计划”。因此，相关的检查计划并没有义务来根据生产商要求进行检查。