031-瓶装包装线验证方案及报告(word文档良心出品).pdf
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1、设备验证方案设备名称验证编号瓶装包装线SMP-VT-031-00*制药厂目录1.验证小组人员名单2.验证方案的起草与审批2.1 验证方案的起草2.2 验证方案的审批3.概述4.验证目的5.验证内容5.1 安装确认5.1.1 资料档案5.1.2 设备安装5.1.3 环境状况5.1.4 公用介质5.1.5 仪表5.2 运行确认5.3 性能确认6.再验证7.时间进度表文档编码:CW9X10S2N10S1 HA7Z6O8P6A8 ZO2N8B7M8C9文档编码:CW9X10S2N10S1 HA7Z6O8P6A8 ZO2N8B7M8C9文档编码:CW9X10S2N10S1 HA7Z6O8P6A8 ZO2
2、N8B7M8C9文档编码:CW9X10S2N10S1 HA7Z6O8P6A8 ZO2N8B7M8C9文档编码:CW9X10S2N10S1 HA7Z6O8P6A8 ZO2N8B7M8C9文档编码:CW9X10S2N10S1 HA7Z6O8P6A8 ZO2N8B7M8C9文档编码:CW9X10S2N10S1 HA7Z6O8P6A8 ZO2N8B7M8C9文档编码:CW9X10S2N10S1 HA7Z6O8P6A8 ZO2N8B7M8C9文档编码:CW9X10S2N10S1 HA7Z6O8P6A8 ZO2N8B7M8C9文档编码:CW9X10S2N10S1 HA7Z6O8P6A8 ZO2N8B7M8
3、C9文档编码:CW9X10S2N10S1 HA7Z6O8P6A8 ZO2N8B7M8C9文档编码:CW9X10S2N10S1 HA7Z6O8P6A8 ZO2N8B7M8C9文档编码:CW9X10S2N10S1 HA7Z6O8P6A8 ZO2N8B7M8C9文档编码:CW9X10S2N10S1 HA7Z6O8P6A8 ZO2N8B7M8C9文档编码:CW9X10S2N10S1 HA7Z6O8P6A8 ZO2N8B7M8C9文档编码:CW9X10S2N10S1 HA7Z6O8P6A8 ZO2N8B7M8C9文档编码:CW9X10S2N10S1 HA7Z6O8P6A8 ZO2N8B7M8C9文档编码
4、:CW9X10S2N10S1 HA7Z6O8P6A8 ZO2N8B7M8C9文档编码:CW9X10S2N10S1 HA7Z6O8P6A8 ZO2N8B7M8C9文档编码:CW9X10S2N10S1 HA7Z6O8P6A8 ZO2N8B7M8C9文档编码:CW9X10S2N10S1 HA7Z6O8P6A8 ZO2N8B7M8C9文档编码:CW9X10S2N10S1 HA7Z6O8P6A8 ZO2N8B7M8C9文档编码:CW9X10S2N10S1 HA7Z6O8P6A8 ZO2N8B7M8C9文档编码:CW9X10S2N10S1 HA7Z6O8P6A8 ZO2N8B7M8C9文档编码:CW9X1
5、0S2N10S1 HA7Z6O8P6A8 ZO2N8B7M8C9文档编码:CW9X10S2N10S1 HA7Z6O8P6A8 ZO2N8B7M8C9文档编码:CW9X10S2N10S1 HA7Z6O8P6A8 ZO2N8B7M8C9文档编码:CW9X10S2N10S1 HA7Z6O8P6A8 ZO2N8B7M8C9文档编码:CW9X10S2N10S1 HA7Z6O8P6A8 ZO2N8B7M8C9文档编码:CW9X10S2N10S1 HA7Z6O8P6A8 ZO2N8B7M8C9文档编码:CW9X10S2N10S1 HA7Z6O8P6A8 ZO2N8B7M8C9文档编码:CW9X10S2N10
6、S1 HA7Z6O8P6A8 ZO2N8B7M8C9文档编码:CW9X10S2N10S1 HA7Z6O8P6A8 ZO2N8B7M8C9文档编码:CW9X10S2N10S1 HA7Z6O8P6A8 ZO2N8B7M8C9文档编码:CW9X10S2N10S1 HA7Z6O8P6A8 ZO2N8B7M8C9文档编码:CW9X10S2N10S1 HA7Z6O8P6A8 ZO2N8B7M8C9文档编码:CW9X10S2N10S1 HA7Z6O8P6A8 ZO2N8B7M8C9文档编码:CW9X10S2N10S1 HA7Z6O8P6A8 ZO2N8B7M8C9文档编码:CW9X10S2N10S1 HA7
7、Z6O8P6A8 ZO2N8B7M8C9文档编码:CW9X10S2N10S1 HA7Z6O8P6A8 ZO2N8B7M8C9文档编码:CW9X10S2N10S1 HA7Z6O8P6A8 ZO2N8B7M8C9文档编码:CW9X10S2N10S1 HA7Z6O8P6A8 ZO2N8B7M8C9文档编码:CW9X10S2N10S1 HA7Z6O8P6A8 ZO2N8B7M8C9文档编码:CW9X10S2N10S1 HA7Z6O8P6A8 ZO2N8B7M8C9文档编码:CW9X10S2N10S1 HA7Z6O8P6A8 ZO2N8B7M8C9文档编码:CW9X10S2N10S1 HA7Z6O8P6
8、A8 ZO2N8B7M8C9文档编码:CW9X10S2N10S1 HA7Z6O8P6A8 ZO2N8B7M8C9文档编码:CW9X10S2N10S1 HA7Z6O8P6A8 ZO2N8B7M8C91.验证小组人员名单组长:*负责组织协调工作组员:*负责起草方案,数据收集、分析、处理,写验证报告。*负责安排实际操作,配合验证。*负责组织检验工作。*负责现场质量监控。2.验证方案的起草与审批2.1 验证方案的起草设备名称设 备 编 号验证编号瓶装包装线1402002-1402007 SMP-VT-031-00 起 草 人部门日期2.2 验证方案的审批审 核 人部门日期文档编码:CX3F5Q3C1F
9、6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U
10、1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F
11、6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U
12、1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F
13、6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U
14、1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F
15、6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1批 准 人部门日期文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5
16、O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:C
17、X3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5
18、O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:C
19、X3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5
20、O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:C
21、X3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H13概述自动包装生产线用于片剂和胶囊剂成品的包装生产,实现包装生产的自动化。生产线组成:PL2000 型自动理瓶机PA2000 型变频
22、式偏心筛动数片机PB2000 型变频式高精度塞纸机PC2000 型变频式自动旋盖机PD100 型晶体管感应式铝箔封口机主要技术参数:生产能力:最大生产能力 60 瓶/分钟瓶子规格:15150cc 塑料圆瓶药片规格:414mm 胶囊规格:02 号瓶盖规格:外径 3336mm 螺口塑料盖4.验证目的4.1 检查并确认自动包装生产线的安装符合设计要求,资料及文件符合GMP规定。4.2 确认自动包装生产线的运行性能符合设计要求。4.3 确认自动包装生产线对片剂和胶囊剂包装生产的适应性及可靠性。5.验证内容5.1 安装确认文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文
23、档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U
24、1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文
25、档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U1P9C5O7 ZP3S7U1P7H1文档编码:CX3F5Q3C1F6 HK8U
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