“三合一”验证文件清单

qiujian6666

1. 项目计划和定义阶段 PLANNING AND DEFINITION 和客户沟通，供应商无正式文件Response to URS, No formal documentation provide by supplier.
2 设计和开发阶段 DESIGN AND DEVELOPMENT 子供应商列表（机械、电气及仪表）
List and schedule of sub-supplier (mach., elect. and instrument.)
质量控制计划Quality Control Plan
生产进度表Manufacturing schedule
设备主体的设计验证文件Equipment Design qualification.
TM(客户需求跟踪矩阵) (URS traceability matrix)
GMP (GMP 风险评估)；Risk analysis report of GMP
计算机系统 computerizing system. QPP(质量项目计划) (Quality project plan) FS(功能说明书) (Functional specification) HDS (硬件设计说明)（Hardware design specification）SDS (软件设计说明) (Software design specification )
3. 开发测试和系统建造Development and testing and system built.
设备主体 EQUIPMENT
材料证书Materials certificate
仪表的检验证Instrument: certified documentation
压力容器检测报告Pressure vessel certificate
焊接工序描述及焊工资格证书。焊接记录及焊接图Welding procedure spec. &
procedure qualifies. Record and welding map
z 竣工图和总图
The final as-built drawing and general arrangement drawings for equipment
液压系统图Hydraulic System Diagram
P&ID 工艺仪器仪表图Pipe and instruction diagram drawing.
软件梯形逻辑/操作和控制流程图Software Ladder logic/operation and controls
flow charts
软件梯形逻辑/操作和控制流程图Software Ladder logic/operation and controls flow charts
电气图，功耗图，控制柜布局图和电缆列表。Electrical schematics, electric power drawing, cabinet layouts and cable list
3.2        互锁图及相关描述Interlocks drawings and descriptions
电气设备列表List of all electric equipment
安装确认文件(IQ) Installation Qualification
运行确认文件（OQ）Operational Qualification
4. 设计审核和系统验收阶段Design review and acceptance
FAT 工厂验收测试；
产品合格证Certificate of conformity
5. 试车和确认commissioning and qualification.
设备安装说明/指南Installation instructions for equipment
主要外购件操作和维护手册Operation and maintenance manual of major outside
purchase parts
z 设备操作和维护手册（包括设备主要元件和系统定期维护表）；
The operation and maintenance manuals
PQ Performance Qualification 性能确认文件（协助客户）
正常操作运行On going operation.
备件清单Spare parts list.
正常操作文件同5 same with 5.
附1 符合GAMP4 和21CFR Part 11 验证要求的文件清单：（已包含在项目寿命周期的各阶段）
Documents list comply with the validation requirement of GAMP4, 21CFR Part 11:（include in above project lifecycle documentation stage）
QPP(质量项目计划) (Quality project plan)
FS(功能说明书) (Functional specification)
HDS (硬件设计说明)（Hardware design specification）
SDS (软件设计说明) (Software design specification )
IOM Manual (安装操作维护说明书) GMP (GMP 风险评估)；
Risk analysis report of GMP FDA 21CFR Part 11 符合性说明;
FDA 21CFR Part 11 compliance explanation TM(客户需求跟踪矩阵) (URS traceability matrix)
附2 符合EU-GMP, ICH Q7A, 美国 FDA 验证文件（已包含在项目寿命周期的各阶段）
（include in above project lifecycle documentation stage）
IQ Installation Qualification 安装确认文件
OQ Operational Qualification 运行确认文件
PQ Performance Qualification 性能确认文件（协助客户）

制药设备

感谢楼主的分享  中英文的{:soso_e183:}

hljhy

谢谢分享

youngzhou

学习了，谢谢分享

lyk

感谢楼主的分享

gen_li

感谢楼主分享，最近正在研究

追风者

谢谢分享！

shinefzb

很棒哦，谢谢啦

玄冰影

谢谢楼主分享