中国_欧盟对原料药GMP检查方面的比较_魏传波.pdf

184 2011 25 2 # GMP 专论# GMP 魏传波, 颜丽萍, 窦学杰 ( , 255000) : 借鉴欧盟在原料药GM P 检查方面的成功经验, 促进中国对药品的GM P 监管分析了 中国欧盟在原料药GM P 检查方面的差 以及造成差 的原因 随着我国新版GM P 即将颁 布实施, 在认证标准上我们与欧盟几乎一致, 但还需不断营造GM P 成长的外围环境 : 原料药; GM P; 欧盟; 现场检查; 差 比较 : R95412 : A : 1002-7777 ( 20 11) 02-0184-03 Differences Analysis on GMP Inspection between China and EU Wei Chuanb , Yan Liping and D u Xuejie ( Shand ng Xinhua Pharmaceutical C 1 , Ltd, Zib 255000) ABSTRACT: bjective T use the successful experiences n GM P inspecti n f EU, and pr m te the GM P supervisi n level f China1 Methods T analyze the differ ences n GM P inspecti n betw een EU and China, and summarize the reas ns1 Results and Conclusion New GM P w ill be issued s n which is in line w ith the EU GM P, h w ever w e sh uld f cus n cultivating the utside envir nment in rder t acceler ate GM P gr w th1 KEYW RDS: APIs; GMP; EU ; site inspecti n; differences analy sis , EDQM ( , , ) COS ( DM F , GM P ) , EDQM , 2007 , EMEAISPEICH PIC/ S , 18% , 2008 GM P , 21% , 2009 9 35% [ 1] GM P; , , , GM P GM P , , 11 2 ? , GM P GM P , 1 GM P , , 11 1 , 98 GMP [ 2] [ 4] GM P , ICH Q 7a , DMF , 98 GM P 14 ( 88 [ 3] ) 0174 , ICH Q7a 19 2 , , , ICH Q7a 98 GM P 3 : , , ; Tel: 20