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Q4. If micronization is included in the ASMF, if the process reviewed by EDQM, if the grade micronized is not applied as CEP name.
A4. Now we expect manufacturers to be declaring what they are doing to obtain the grade of substance, if there are physical process steps carried out, you should be declaring that. But as you probably know it’s optional to include in the subtitle a grade like micronized. Now, if we have not included that subtitle in the CEP, that means we have not evaluated that part of the process, we have not taken a critical review on that. And therefore (without) this information if you are going to be using the certificate for a micronized grade of material, you need to be providing to your customers all of the information dealing with micronization, you need to be providing the description of the method which is used to determine whether the material meets the specification for micronized grade material. And this information has to be submitted to the national competent authorities in the context of the medicinal product, and it is them who would be evaluating this. So we expected things to be declared in the file. So if physical processes are being carried out, you should be declaring it in the file. But if you’re not gonna put subtitle on the certificate, we will not evaluate that.
如果申报人想要将API微粉级别体现在CEP证书副标题 , 就应提交相应信息。如果证书副标题上显示API微粉级别，则表明EDQM已审评并批准相应内容；反之亦然，则申报人就应将微粉工艺描述提供给申报制剂的客户，由国家主管机构进行审评。
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微粉化后产品的质量可能发生变化，如稳定性，晶型等，一般CEP申报也会要求加上微粉的副标题，因此需要包含微粉的工序，重新递交DMF资料的。
不管用什么方式微粉，总是要对颗粒做功，那么就非常有可能影响产品的晶型、堆密度、稳定性等，还有既然有微粉的需求，肯定是不同的制剂产品在溶出等方面有不同的要求，综上考虑应该需要加做微粉的稳定性实验并同普粉的稳定性数据进行对比分析，也一定需要在DMF文件里加入微粉步骤重新递交。