上个月EDQM出了一个与此相关的问答：How to present the specification for a substance in a CEP application? 

The specification for the substance should primarily demonstrate compliance with the Ph. Eur. monograph and with European regional requirements. Therefore, it should not include quality attributes that are included only for the purpose of demonstrating compliance with pharmacopoeias other than the Ph. Eur. Including such quality attributes may:

• Cause a delay in the CEP being granted or revisions accepted.
• Increase the likelihood of more frequent revisions of the CEP during its lifecycle.

Despite this, if a CEP applicant/holder decides to include quality attributes that are intended to satisfy a regulatory requirement in another region (i.e. non-European regional requirement) in their specification, they should present them separately (e.g. in an additional table) and identify them accordingly as shown below:

This approach helps maintain clarity and avoids unnecessary burden during evaluation of the CEP application and eases lifecycle management and the use of the CEP.

微生物项目在通则中进行规定，一般可以在企业内控放行标准中列出批检或定期测试，基于科学评估依据。其测试方法需要做方法适用性验证

1. 如果用于质量控制，方法均需要进行适用性确认。

2. API专论中未要求，但用于API质量控制的检验项目在S41中单独的表中列出。