GMP与洁净厂房技术规范.doc

文档介绍：--------------------校验:_____________--------------------日期:_____________GMP与洁净厂房技术规范《GMP》与洁净厂房   ——《GMP》对药品生产企业的要求——《GMP》中净化空调的技术措施——《GMP》与洁净生产厂房的认证                    目     录    目    录                                                           1一、GMP的基本概念                                                    2二、中国GMP的发展历史..............................................................................................2三、99版GMP的主要纲领.............................................................................................2四、GMP对洁净厂房的要求..........................................................................................31、洁净厂房的洁净级别...........................................................................................32、洁净室的气流组织...............................................................................................53、生物洁净技术的原则...........................................................................................64、净化过滤的选择与特性......................................................................................65、静电自净器..........................................................................................................76、洁净室洁净度的检测与措施                                         8五、GMP对生产设备的一般要求..................................................................................8六、GMP对卫生学的要求...............................................................................................9七、GMP对生产管理的要求........................................................................................111、GMP对原料、辅料及包装材料的要求.........................................................112、GMP对生产管理的特殊规定..........................................................................113、GMP对包装与贴签的要求..............................................................................124、GMP管理文件的编制执行..............................................................................13八、GMP对制药洁净厂房的要求................................................................................131、总体要求........................