资源描述
《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
名目
名目 １
一、ＧMＰ的基本概念 2
二、中国GMP的进展历史．．........．.．.．．．．.....．.．．..．.．．.......．.．....．....．.........．....．.．.......．.......．...．．.．． 2
三、9９版GＭP的主要纲领.．..．．........．．．......．..．...．．．....．..........．....．...．...．...．．．..．.．．．.．.．.．．........... 2
四、GMＰ对洁净厂房的要求.....．．.．.......．．．．.....．.．.．...．.．......．．．．．．....．．.．.........．．．.．...．.......．.．....．． 3
１、洁净厂房的洁净级别．．．.．．...．......．..．..．..．．．........．...．.．...．．...．...．.....．．．.....．.．.．...．.．.．．．....．．． 3
2、洁净室的气流组织......．．....．.．．．.．．........．.....．.......．.．.．...．..．...．..．..．......．..．..．．.....．.....．.．．.. 5
3、生物洁净技术的原则..．....．．.．.．．.......．．.....．．．．.......................．.．．．...．..．．..．....．.．....．......．． 6
４、净化过滤的选择与特性.．．．..．....．.......．.．．.......．．.....．.....．...．.．.．．．．...．..．．.．.．...．．．．.．..．.．．.... ６
5、静电自净器．........．．.....．．.．.．.．.．．．..．．.....．．.．．.....．..．......．．.．...........．.．．.．．..．..．..．．.....．.....．...．. 7
６、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.........．.．.....．．...．..．.．.．．．.....．．......．．．.．..．．．..．．.．.．....．.．..．......．...．..．. 11
1、GＭP对原料、辅料及包装材料的要求...．......．.．..．.．．..．.．．．..．．......．．．...．.．.．...．.．.... 11
2、GMP对生产管理的特殊规定．........．....．......．.．......．..．.．．..．.．．...．．......．．．.．....．....．..．.. 11
3、GMP对包装与贴签的要求.．...．．.．..．...．．..．．.........．..．．．．．....．...．....．.．.....．..．.......．.....．. １２
4、ＧＭP管理文件的编制执行..．...．.．．．．....．...．..．.....．．..．....．..．.....．.．.．．．..．...．.....．.．.．....... １３
八、ＧＭＰ对制药洁净厂房的要求.．..．．..．..．.．...．.....．...．．...．.．.．........．．......．.．.．．．．...．．..．...．．...．.. １３
１、总体要求...．.．．..．..．.....．..．......．．．.．．．.．..．.．．...．...．．....．.．．..．..．..．．．..．．....．......．....．．．..．.．.．........． １3
2、制药生产企业洁净室的特点15
九、空气净化措施........．...．．.......．...．..．．．．.．.．..．...．．．.．.．.．．..．.....．．.．．....．...．．...........．...．..．.．．...．.....． １8
1、空气过滤......．..．.......．．.．..．.．..．．．..．．.．.．.．....．．..．．.．...．......．....．．.．.....．...．...．．..．.．．.．.....．．..．..... １8
2、净化系统中的三级过滤..．.....．.........．........．．....．...．．..........．..．.....．.......．．.．．．..．．.．....．. 19
3、过滤除菌．．....．.....．．.．..．．．..．.．..．..．．.．..．..．．....．.......．.．.．.．.．.．.......．.．．.．．．．.....．...．．...．．..........．.． １9
４、洁净室的气流组织和换气次数.．...．........．....．............．．．..．..．．．．.．...．....．...．...．..．.．.．.. 2０
5、洁净室的正压把握......．...．.．.．.．....．.．...．．..．．...．．.......．..．．．.．.......．．．...．..．．.．.．．..．.．.．..．.．....． 2１
十、水和气体的净化措施.．.......．..．.．.........．...．．．....．...........．．．．....．...．...．．...．....．．.．．.．.．....．.．..... ２３
1、水的净化...．.．...．．...．.....．.................．．..........．．..．．．....．...．.．．..．.．．...........．....．．.．...．......．．... 23
２、气体净化．．.．...．.．.．...．..．．．...．..．......．．..．.．.....．.．.．.．．．．..．．．......．．．.．...．...．.．．．...．．．...．.．...．.．．．...．.． ２4
3、洁净区的排水．．．.．．．．..．...．.．..．．．.....．．...．．.．...．．......．...............．．..．．．.．.．...．．..．..．.．.．............ 24
十一、洁净室的测定２5
1、悬浮颗粒的测定.．...．...．.．.....．..．.．．....．．．.．．..．..．........．..．．.．...．.．...．．..．.．．．...．.．...．.......．..．．.. 2５
2、活微生物的测定.．..．.．..．．..．．．...．.........．.．..．.．..．...．．．.．....．.．．．..．．............．.．...．................． 2６
十二、洁净室的消毒方法．．...．........．..．．..．....．..．..........．.．.．....．．.．．.．．....．....．........．...．.．．.．...．．.．.. 31
1、灭菌．.．．.．．．．．.．..．.．..．.......．．.．.．.．...．....．...．．...．...．..．.．．....．．．.．........．．.....．...．.．．．...．..．.．.．.．.....．．.. 3１
２、除菌...．.．．....．..．..．.．．..．....．．．．．．.．．....．．.．.．．...．........．．......．....．．．...．.．．.．．..．．.．..．．.．...．......．.....．.．. 31
3、消毒的方法..．....．．...．．...........．...．...．．...．．．．..........．．.．....．．.．......．.．.......．....．...．.．..．．．．．.．．．.．. ３２
十三、其它.．....．．．．..．.....．．....．．......．..．．.．......．.....．.．....．．...．...．...．．.．....．........．．.......．......．..．....．．．．．... 33
GMP与洁净厂房的建设要求
南通长城净化空调工程公司
秦新华
一、ＧMP的基本概念
GMP是《优良药品生产标准》的英文Good ｍanufａｃtｕrｅ Practicｅ foｒ Dｒuｇs的简称，我国制定为《药品生产质量管理规范》。《GMP》是在药品生产全过程中用科学、合理、规范化的条件和方法来保证生产优良药品的一整套科学管理方法和实施措施。实施GＭP的目的就是为了使用者能得到优质的药品,但又不是仅仅通过最终的检验来达到的,而是在药品生产的全过程实施科学的全程管理和严密的监控来获得预期质量的药品。因此GMP要求药品生产企业必需从收进原料开头始终到制造、包装、贴标签、出厂等各项生产步骤和操作都制订出明确的准则和管理方法，同时通来严密的生产过程管理与质量管理来对上述各个环节实施正确的检查、监控和记录。
二、中国《ＧMP》的进展与历史
19８8年8月卫生部公布了我国第一部《药品生产质量管理规范》简称《ＧMP》规范,由于内容比较原则,因此1989年—1990年卫生部组织有关人员起草《实施细则》,1９９１年打算依据《规范》和《细则》的内容重新修订《药品生产质量管理规范》。
新修订的《药品生产质量管理规范》（1992)已于1９９３年２月16日颁布。
在以后的实践中逐步进行了修改,先后出版了(9８）版《药品生产质量管理规范》和（１999/6/18)版《药品生产质量管理规范》,现今以９9版指导ＧMＰ的实施和认证。
三《药品生产质量管理规范》(99修订版)主要内容
新版《GMＰ》(即指１９99/6/１8日修订版)既从我国的药品生产总体水平和即将加入世贸组织的特殊要求动身以严格坚持GMP的基本准则为手段,与现代国际标准相接轨，敦促指导国内制药企业规范化、标准化和规模生产建设。
新版《GMＰ》对以下几方面进行了阐述:１总则;2人员;3厂房;４设备;５卫生;６原料、辅料及包装材料;7生产管理;8包装和贴签;9生产管理和质量管理;10文件质量管理部门；1１自检;12销售记录;1３用户意见和不良反应报告；1４附录。
新规范参照世界卫生组织和发达国家GMP的要求,规定了药品生产厂房的洁净度级别和适用于药品生产的种类和工序；对中药材的前处理、提取、浓缩及动物脏器、组织的洗涤或处理的厂房和有关生产操作要求作出了规定,对中成药生产的后续工序——制剂制造，在ＧＭP方面的要求与化学药品的制剂生产应相同
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