药品生产质量管理规范(GMP).ppt
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1、WORKSHOP ON GOOD MANUFACTURING PRACTICES(WORKSHOP ON GOOD MANUFACTURING PRACTICES(GMPsGMPs)INSPECTION FOR VACCINES)INSPECTION FOR VACCINESWHO药品生产质量管理规范培训(GMP)厂房和无菌生产厂房和无菌生产 WORKSHOP ON GOOD MANUFACTURING PRACTICES WORKSHOP ON GOOD MANUFACTURING PRACTICES(GMPsGMPs)INSPECTION)INSPECTIONWORKSHOP ON GOO
2、D MANUFACTURING PRACTICES(WORKSHOP ON GOOD MANUFACTURING PRACTICES(GMPsGMPs)INSPECTION FOR VACCINES)INSPECTION FOR VACCINESWHO目的目的1.对总的要求的回顾 2.对无菌产品生产设施所必需的检查要素进行培训WORKSHOP ON GOOD MANUFACTURING PRACTICES(WORKSHOP ON GOOD MANUFACTURING PRACTICES(GMPsGMPs)INSPECTION FOR VACCINES)INSPECTION FOR VACCIN
3、ESWHO原则原则厂房首先需选址、设计、建造、操作调试和维修保养:降低差错和交叉污染的危险性有利于有效清洁有利于有效保养维修降低灰尘和颗粒消灭任何对质量有影响的因素WORKSHOP ON GOOD MANUFACTURING PRACTICES(WORKSHOP ON GOOD MANUFACTURING PRACTICES(GMPsGMPs)INSPECTION FOR VACCINES)INSPECTION FOR VACCINESWHO原则厂房应位于降低交叉污染危险性的地方,如:厂房建筑不能与啤酒厂相邻,因为空气中有大量的酵母菌WORKSHOP ON GOOD MANUFACTURING
4、 PRACTICES(WORKSHOP ON GOOD MANUFACTURING PRACTICES(GMPsGMPs)INSPECTION FOR VACCINES)INSPECTION FOR VACCINESWHO厂房厂房的建造应的建造应:有利于卫生清洁.易于保养和清洁有服务保障避免昆虫和其他动物进入WORKSHOP ON GOOD MANUFACTURING PRACTICES(WORKSHOP ON GOOD MANUFACTURING PRACTICES(GMPsGMPs)INSPECTION FOR VACCINES)INSPECTION FOR VACCINESWHO辅助区辅
5、助区休息和就餐的房间更衣、洗手和卫生间区域维修保养间动物房WORKSHOP ON GOOD MANUFACTURING PRACTICES(WORKSHOP ON GOOD MANUFACTURING PRACTICES(GMPsGMPs)INSPECTION FOR VACCINES)INSPECTION FOR VACCINESWHO设计设计原则原则生产流向物料流向人员流向WORKSHOP ON GOOD MANUFACTURING PRACTICES(WORKSHOP ON GOOD MANUFACTURING PRACTICES(GMPsGMPs)INSPECTION FOR VACC
6、INES)INSPECTION FOR VACCINESWHO厂房物流和人流举例物流和人流举例 物品到达 参观者入口 员工入口 物品运输 Zone:Clean Zone:Packaging Zone:Controlled Material FlowPersonnel FlowWORKSHOP ON GOOD MANUFACTURING PRACTICES(WORKSHOP ON GOOD MANUFACTURING PRACTICES(GMPsGMPs)INSPECTION FOR VACCINES)INSPECTION FOR VACCINESWHOA级区域严格的无菌生产区域,无菌产品及暴露
7、在环境中与产品接触的材料。在该区域进行高风险的操作(灌装、最后的除菌过滤、无菌连接、收获)。WORKSHOP ON GOOD MANUFACTURING PRACTICES(WORKSHOP ON GOOD MANUFACTURING PRACTICES(GMPsGMPs)INSPECTION FOR VACCINES)INSPECTION FOR VACCINESWHOB级区域无菌生产区域,无菌产品接触的材料应避免环境的污染。B级生产区域用在无菌产品的传输,包裹除菌过滤用具,具有A级生产区域的背景环境。WORKSHOP ON GOOD MANUFACTURING PRACTICES(WORK
8、SHOP ON GOOD MANUFACTURING PRACTICES(GMPsGMPs)INSPECTION FOR VACCINES)INSPECTION FOR VACCINESWHOC级区域非严格区域,材料暴露在环境中,还未进行最后的灭菌。C级区域是生产活动的支持区域,灭菌前的成分制备、设备准备等。WORKSHOP ON GOOD MANUFACTURING PRACTICES(WORKSHOP ON GOOD MANUFACTURING PRACTICES(GMPsGMPs)INSPECTION FOR VACCINES)INSPECTION FOR VACCINESWHOD级区域
9、非严格生产活动的支持区域,未加工的成分或材料能够暴露在环境中。所有其他的产品或材料必须装在密闭的容器中。清洁区域用于无菌产品的非严格阶段。WORKSHOP ON GOOD MANUFACTURING PRACTICES(WORKSHOP ON GOOD MANUFACTURING PRACTICES(GMPsGMPs)INSPECTION FOR VACCINES)INSPECTION FOR VACCINESWHO无菌生产最终灭菌WORKSHOP ON GOOD MANUFACTURING PRACTICES(WORKSHOP ON GOOD MANUFACTURING PRACTICES(
10、GMPsGMPs)INSPECTION FOR VACCINES)INSPECTION FOR VACCINESWHO典型生产步骤典型生产步骤无菌生产无菌生产最终消毒最终消毒背景背景暴露暴露背景背景暴露暴露原材料原材料分发分发C局部保护局部保护CC混合和混合和过滤过滤CBCC过滤过滤(除菌除菌)BACA准备准备/清洗清洗DDDD最后淋洗最后淋洗CCDC灭菌柜装货灭菌柜装货CCDC灭菌柜卸货灭菌柜卸货BA 或包裹或包裹好的好的CA或包裹好或包裹好的的WORKSHOP ON GOOD MANUFACTURING PRACTICES(WORKSHOP ON GOOD MANUFACTURING PR
11、ACTICES(GMPsGMPs)INSPECTION FOR VACCINES)INSPECTION FOR VACCINESWHO典型生产步骤典型生产步骤无菌生产无菌生产最终消毒最终消毒背景背景暴露暴露背景背景暴露暴露灌装和灌装和 压塞压塞BACA冻干操作冻干操作_密闭系统密闭系统_冻干转移冻干转移BA_压盖压盖D局部保护局部保护D局部保护局部保护外观检查外观检查DDDD贴签和贴签和包装包装DDDDWORKSHOP ON GOOD MANUFACTURING PRACTICES(WORKSHOP ON GOOD MANUFACTURING PRACTICES(GMPsGMPs)INSPEC
12、TION FOR VACCINES)INSPECTION FOR VACCINESWHO环境级别控制颗粒物质生物载量温度室温 20-25湿度 45-55%压力换气次数送风速度WORKSHOP ON GOOD MANUFACTURING PRACTICES(WORKSHOP ON GOOD MANUFACTURING PRACTICES(GMPsGMPs)INSPECTION FOR VACCINES)INSPECTION FOR VACCINESWHO微生物污染限度级别空气样品(CFU/m3)沉降碟(直径 90 mm,CFU/4 小时)接触碟(直径 55 mm)CFU/Plate手套印压(手指
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- 关 键 词:
- 药品 生产 质量管理 规范 GMP
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