DMF中的module3 的Reference standars or materials

蓝蓝的天空

请教这个对照品的模块下还需要提供自制对照品的制备工艺吗？已申报过的企业，你们是如何做的呢？谢谢参与的人！

潇湘子

一般来说，对照品两种来源，外购或自制，上购的法定对照品，要有正规发票证明来源。如果不是外购的，你就得提供制备精制工艺，同时还需提供自行标定的记录。

蓝蓝的天空

谢谢潇湘子的回答，这个版块人气不旺

蓝蓝的天空

根据法规的要求：
REFERENCE STANDARDS OR MATERIALS (S.5)

Information on the reference standards or reference materials used for testing of the drug substance (active moiety) should be provided.   If the reference standard is obtained from an official source, this should be stated.  When the reference standard is not from an official source, it should be fully characterized.   Recommendations on the information that should be provided for reference standards will be provided in a forthcoming CDER/CBER guidance for industry on Analytical Procedures and Methods Validation:   Chemistry, Manufacturing, and Controls Documentation.   A list of any available reference standards for impurities and intermediates should be included in S.5.  
  Whether or not information is included in the application, complete records must be maintained of any testing and standardization of laboratory reference standards (21 CFR 211.194(c)).