工艺验证方案模板电子教案
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工艺验证方案模板 精品文档 收集于网络，如有侵权请联系管理员删除 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）：
Verify completion date: 验证完成日期： Validity: 有 效 期：
Index 目录 精品文档
收集于网络，如有侵权请联系管理员删除 1. Purpose目的 ............................................................................................................. 6
2. Scope范围 ................................................................................................................ 6 3. Responsibility职责 ................................................................................................... 6 3.1 AAA responsibilities AAA的职责 ....................................................................................... 6 3.2 XXX responsibilities XXX的职责 ...................................................................................... 6
4. Regulation and Guidance 法规和指南 ..................................................................... 9 5. Abbreviations缩略语 .............................................................................................. 10 6. Protocol Description方案说明 ............................................................................... 12 7. Product And Process Description产品和工艺描述 .............................................. 15 7.1 Product specification ......................................................................................................... 15 7.2 Drug approval No. ............................................................................................................. 15 7.3 Standard Followed: ........................................................................................................... 15 7.4 Raw Materials and Adjuvants原辅料情况 ......................................................................... 15 7.5 Process description: .......................................................................................................... 17 7.6 Process Recipe工艺处方： .............................................................................................. 21 7.7 List of Production Plants生产车间一览 ............................................................................. 26 7.8 List of Production Equipment 生产设备一览 ..................................................................... 29 7.9 Process Flow Diagram 工艺流程图 ................................................................................... 32 7.10 CPP Identification CPP确认 ............................................................................................ 32 7.11 Validation Plan验证计划 ................................................................................................... 46
8. Validation prerequisite验证先决条件 .................................................................... 48 8.1 Personal Identification人员确认 ....................................................................................... 48 8.2 Process Documentation Verification 生产文件确认 .......................................................... 48 8.3 Training Verification 培训确认 ........................................................................................... 49 8.4 System and Equipment Instruments Calibration Verification 系统和设备仪表校验确认 .. 49 8.5 System and Equipment Instruments Calibration Verification 生产相关验证状态确认 ...... 50 8.6 Test Instruments Calibration Verification 测试仪器和仪表校验确认.................................. 50 8.7 Testing Method Validation Verification检验方法验证的确认 ............................................. 51 8.8 Raw Material and Excipient Verification原辅料确认 ......................................................... 51
9. Sampling Plan and Evaluation Criteria取样计划及评估标准 ............................... 53 10. Sample Coding Method样品编码原则 ................................................................... 66
