工艺验证方案模板.doc

Process Validation (PV) Protocol XXX
XXX工艺验证方案
Written by
起草人
Written date
起草日期
年月日
Reviewed by审核人
Reviewed date
审核日期
年月日
Approved by批准人
Approved date
批准日期
年月日
Written department
起草部门
Effective date
生效日期
年月日
Issued by:
颁发部门: [ ]
Copy number:
拷贝号: [ ]
Change record:
Revision number
变更记载: Date of approval Effective date
修订号批准日期生效日期

Change reason and goal:
变更原因及目的:
Distribution department:
分发部门:
所长办公室[ ] 人力资源部[ ] 后勤保卫部[ ] 物资供应部[ ] 工程服务部[ ]
生产管理部[ ] 质量保证部[ ] 销售部[ ] 仓储部[ ] 疫苗一室[ ]
疫苗二室[ ] 疫苗三室[ ] 疫苗五室[ ] 疫苗六室[ ] 生化制品室[ ]
细胞因子室[ ] 血清制品室[ ] 实验动物室[ ] 分包装室[ ] 培养基室[ ]

Verification department (department):
验证科室(部门):
pletion date:
验证完成日期:
Validity:
有效期:
Index 目录
1. Purpose目的 5
2. Scope范围 5
3. Responsibility职责 5
AAA responsibilities AAA的职责 5
XXX responsibilities XXX的职责 6
4. Regulation and Guidance 法规和指南 8
5. Abbreviations缩略语 9
6. Protocol Description方案说明 11
7. Product And Process Description产品和工艺描述 14
Product specification 14
Drug approval No. 14
Standard Followed: 14
Raw Materials and Adjuvants原辅料情况 14
Process description: 16
Process Recipe工艺处方: 21
List of Production Plants生产车间一览 26
List of Production Equipment 生产设备一览 29
Process Flow Diagram 工艺流程图 33
CPP Identification CPP确认 34
Validation Plan验证计划 49
8. Validation prerequisite验证先决条件 51
Personal Identification人员确认 51
Process Documentation Verification 生产文件确认 51
Training Verification 培训确认 52
System and Equipment Instruments Calibration Verification 系统和设备仪表校验确认 52
System and Equipment Instruments Calibration Verification 生产相关验证状态确认 53
Test Instruments Calibration Verification 测试仪器和仪表校验确认 53
Testing Method Validation Verification检验方法验证的确认 54
Raw Material and Excipient Verification原辅料确认 54
9. Sampling Plan and Evaluation Criteria取样计划及评估标准 56
10. Sample Coding Method样品编码原则 70
11. Process Validation Test Execution 工艺验证执行 72
Liquid Preparation 液体配制 72
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