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1、北京御本堂药业有限公司 GMP确认方案厂房系统确认方案编号：YZ-CF-F-001 2015 年北京御本堂药业有限公司北京御本堂药业有限公司方案编号：YZ-CF-F-001 第 1 页 共 32 页确认方案的起草与审批方案起草起 草 人职务日期方案审核审 核 人职务日期方案批准批 准 人日期文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S
2、10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2
3、E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6
4、X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码
5、:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5
6、Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5
7、 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T
8、2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5北京御本堂药业有限公司方案编号：YZ-CF-F-001 第 2 页 共 32 页目录1.确认目的 .32.确认范围 .33.确认职责 .34.确认指导文件 .45.术语缩写 .46.概述.57.确认实施前提条件 .58.人员确认 .59.风险评估 .610.确认时间安排 .1011.确认内容 .1012.偏差处理 .1413.方案修改记录 .1414.风险的接收与评审 .1515.确认计划 .1516.附件.15文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10
9、 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6
10、C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5
11、文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:C
12、G8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8
13、L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 H
14、P10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H
15、1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5北京御本堂药业有限公司方案编号：YZ-CF-F-001 第 3 页 共 32 页1.确认目的检查并确认固体车间、液体车间、外用车间、提取车间和库房以及质量部符合GMP 及生产工艺要求，文件符合GMP 的管理要求。检查并确认厂房及
16、装修所用材质、设计、制造符合GMP 要求。检查并确认厂房的文件资料齐全,并且符合GMP 要求。检查并确认厂房的建设及改造符合要求,公用系统配套齐全,并且符合设计要求。检查并确认厂房所用及相关的各种仪器仪表经过检查校正合格。检查并确认各种控制功能符合设计要求。检查并确认厂房能达到设计标准。2.确认范围本次主要对厂房的固体车间、液体车间、外用车间、提取车间和库房以及质量部和进行确认。3.确认职责3.1.验证委员会3.1.1.负责所有确认工作的组织和领导。3.1.2.负责对确认系统的风险评估结果进行审核和批准。3.1.3.负责对确认中出现的风险和确认结果进行分析讨论，并作出评价，决定再确认周期。3.
17、1.4.负责对确认系统的变更进行审核和批准3.1.5.提出全厂的年度及长期确认工作计划，包括确认的项目，周期及时间安排等。3.1.6.组织协调确认活动，提供确认所需资源，确保确认进度。3.1.7.审批确认报告。3.2.确认小组3.2.1.负责确认方案的制订、实施与协调，组织确认的相关培训。3.2.2.执行并确认确认方案中的内容，并对实施过程中出现的结果进行分析，对出现的偏差填写“偏差调查处理表”，并上报验证委员会。3.2.3.对确认系统的变更按照变更控制管理规程提出变更申请。3.2.4.负责收集各项确认、试验记录并归入确认文件中。3.2.5.准备和起草确认报告。3.3.设备部3.3.1.负责厂
18、房的预防性维修、保养计划的制订和实施。3.3.2.负责仪器、仪表的校准或检定。文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B
19、5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B
20、5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10
21、T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4
22、S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK
23、2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W
24、6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5北京御本堂药业有限公司方案编号：YZ-CF-F-001 第 4 页 共 32 页3.3.3
25、.负责为厂房、设施、确认工作提供技术指导。3.4.质量部 QC 3.4.1.负责对确认过程中检测过程，对方案中的检查结果进行审查及偏差分析。3.4.2.负责完成确认过程中的试验记录。3.5.质量部 QA 3.5.1.负责对确认的结果进行审核批准3.5.2.负责确认报告的编制和总结3.5.3.负责确认文档的管理3.6.生产部车间3.6.1.负责厂房的清洁、消毒管理规程。3.6.2.协助质量管理部、设备部完成确认。4.确认指导文件下列文件是确认的基础文件：4.1.内部文件文件名称文件编号确认与验证总计划SMP YZ-001-02(0)确认与验证管理规程SMP YZ-002-02(0)变更控制管理规
26、程SMP-QA-006-02(0)偏差处理管理规程SMP-QA-006-02(0)4.2.相关法规文件药品生产质量管理规范2010 修订版5.术语缩写缩写描述IQ 安装确认OQ 运行确认PQ 性能确认文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 Z
27、K2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4
28、W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档
29、编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8
30、B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2
31、B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP1
32、0T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y
33、4S10 ZK2E6C4W6X5北京御本堂药业有限公司方案编号：YZ-CF-F-001 第 5 页 共 32 页6.概述工厂坐落于北京市怀柔区庙城镇工业开发区88 号，于 2015 年 4 月改建完成，工厂整体设计由北京晨奥高科技发展有限公司设计完成。2015 年 4 月投入使用，厂区内有膏体车间、固体车间、液体车间、提取车间、化验室、仓库、综合办公楼及相关公用配套设施。厂区占地面积11.4 万平方米，建筑面积4932.42 平方米，其中固体车间1288.58 平方米（洁净区 1101.38 平方米），液体车间866.46 平方米（洁净区453.00 平方米），膏体车间100.36 平方米（洁
34、净区89.96 平方米），提取车间321.00 平方米，成品库房546.57 平方米，原料库房567.65平方米，包材库房556.4 平方米，标签库35.40 平方米，实验室面积335.00 平方米，办公室面积315 平方米。生产车间和库房主体为钢结构，建筑高度7 米（其中提取车间高度9 米），耐火等级为二级，防水等级为二级，面板材质为彩钢板。实验室和办公楼为框架建筑结构。洁净区域的墙面、吊顶全部采用洁净板材料，板之间为嵌入式联接，接缝处用玻璃胶填充并打磨平整。洁净区窗户采用透明玻璃，用铝合金框架固定，并加双面斜压条，与洁净板相连接的各转折部位，都采用铝合金园弧铝处理阴阳角，不留死角。地面铺自
35、流平（环氧树脂）。墙面与吊顶采用铝合金园弧铝包边，特制的铝合金园弧角铝包角，采用以上材料和经过以上处理的洁净区内表面平整光滑，无裂缝，接口严密，门为洁净门，此外，洁净板与铝合金本身无颗粒物脱落，并能耐受清洗和消毒处理。车间洁净区为D级，保证了各洁净区净化效果均符合工艺要求。7.确认实施前提条件7.1.各相关人员已经经过岗位培训且考核合格，见质量部培训签到表和员工培训档案。7.2.各相关文件系统已编制完成并经过审批。8.人员确认确认小组成员部门人员职责设备部负责承担具体确认项目的实施工作。生产部配合确认项目的实施。质量部 QC 负责实施方案中涉及微生物检验方面的工作。质量部 QA 负责确认项目实
36、施的现场监督。文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X
37、5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:
38、CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y
39、8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5
40、HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2
41、H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S1
42、0 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5北京御本堂药业有限公司方案编号：YZ-CF-F-001 第 6 页 共 32 页确认小组组长部门人员职责设备部负责组织起草确认方案并按批准方案组织实施；督
43、促确认人员做好记录；负责各阶段确认结果汇总及评价、组织起草确认报告；组织相关培训确认小组成员和所有参与测试的人员均经过确认方案的培训，记录在附表1：确认方案培训签到表中。9.风险评估使用风险优先分级方式，定量确定风险的严重性，将已识别和分析的风险与风险成分定量分级表比较，得出风险评估的结果。得分风险发生可能性（O）风险的严重性(S)可测定性(D)5 经常发生（几天一次）直接影响产品质量要素或工艺与质量数据的可靠性、完整性及可跟踪性，导致产品不能使用，直接影响GMP 原则，危害生产活动风险不易被发现，或者不存在能够检测。4 时常发生（几周一次）直接影响产品质量要素或工艺与质量数据的可靠性、完整性
44、及可跟踪性，导致产品召回或退回，不符合GMP 原则，可能引起检查或审计中产生偏差必须通过取样等手段才能发现3 偶尔发生（少于每月一次）不存在对产品或数据的影响，但仍间接影响产品质量要素或工艺与质量数据的可靠性、完整性及可跟踪性，可能造成资源极度浪费或对企业形象产生较坏影响定期检查能发现文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10
45、ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C
46、4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文
47、档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG
48、8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L
49、2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP
50、10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1Y4S10 ZK2E6C4W6X5文档编码:CG8B5Y8L2B5 HP10T2H1