EMA关于原料药预混剂的问答 20160412

julia朱玉姣

12 April 2016
EMA/CHMP/CVMP/QWP/152772/2016
Committee for Medicinal Products for Human use (CHMP)
Committee for Medicinal Products for Veterinary use (CVMP)
Quality Working Party questions and answers on API mix
质量工作组关于原料药预混剂的问答

Introductorynote 介绍

TheseQ&A have been developed to provide information on how to deal with mixturesof API and excipients (called API mix), and to identify situations where itwill be acceptable to use the ASMF/CEP procedure and perform manufacture underEU GMP Part II for the API mix.

这些问答是为了提供关于如何处理原料药与辅料混合物（称为原料药预混剂）的信息，识别出什么情形采用ASMF/CEP程序是可以接受的，以及根据EU GMP第二部分来生产原料药预混剂。

syhorchid

谢谢分享

郭雷

质量工作组关于原料药预混剂的问答

cutte823

学习，谢谢

baoyue2022

谢谢分享，请问最新还有对于原料+辅料预混的法规法规吗？