工厂验证主计划模板中美天津史克.docx

1、工厂验证主计划模板中美天津史克Approval and Authorization批准和授权Completion of the following signature blocks signifies the review and approval of this document完成以下签字意味着完成了对此文件的回顾和批准 Name姓名Job Title/Role职位/角色Signature签字Date日期The Author is signing to confirm that this document has been prepared in accordance with an ap

2、proved document management process that content is consistent with the deliverable definition found in the SOPXXXX Site Validation Approach, and that relevant input from any contributory authors has been included.作者的签字证明文件是按照批准的文件管理规程准备的，其中内容符合SOPXXXX 工厂验证流程对验证文件的定义。并确认相关人员的意见均已包含在文件中后签署文件。Validatio

3、n EngineerCompliance & Validation are signing to confirm compliance with applicable pharmaceutical regulatory agency requirements and Company standards.法规和验证的签字确认其符合制药法规组织的要求和公司标准。Validation ManagerQuality ManagerSite Director is signing to confirm projects in site and provide the required resources

4、 for validation activities.工厂总监的签字是确认工厂需要进行的项目和为工厂验证活动提供需要的资源。Site DirectorDistribution List分发清单 No Distribution Required不需要分发 Field Execution Copy在执行过程中需要复印件 Copy No复印件编号Issued To (Name / Department)交给（姓名部门）Issued By (C&V)由谁生效（法规和验证组）Date of Issue生效日期123目录Content1 目的 Objective2 该工厂验证总计划是为了提供一个对XXXX

5、公司制药有限公司的验证工作的综合描述。具体而言，该计划将： The purpose of the SVMP is to provide a comprehensive overview of all validation activities in XXXX公司. The plan will cover following:1) 列出公司在进行验证工作时所必须遵循的指导方针与指南。List the governing policies and procedures that must be followed in validation activities.2) 确定公司各部门和主要管理人员在

6、验证工作中的主要责任。Define the responsibilities of key personnel in validation activities.3) 列出公司目前主要的验证工作类别以及与其相关的验证主计划。List the main validation activities in the site and the references to the validation master plans.4) 描述公司目前正在进行和计划将要进行的验证工作和项目的程序和进展。Describe the execution status of validation activities

7、that are in process or in plan.3 验证的指导方针与规程Validation Polices and Procedures 生产厂关键规程列表如下：Key site procedures are listed in the table below.文件名称 Document Name文件编号 SOP Number工厂验证管理规程 Site Validation Approach分析仪器验证通则 Analytical Equipment Validation Approach化学检验方法验证规程 Chemical Analysis Method Validation

8、 Approach生产设施验证规程Manufacturing Facility Validation验证草案和报告的生成 Generation of Qualification Protocols and Reports设计确认程序Validation Procedure for Design Qualification安装确认程序Validation Procedure for Installation Qualification运行确认程序Validation Procedure for Operational Qualification性能确认程序Validation Procedure

9、 for Performance Qualification计算机验证方法 Computer Validation Approach清洁验证 Cleaning Validation维护系统的验证状态 Maintaining Systems the Validated Status 控制系统Control System Validation Approach系统影响性评估System Impact Assessment 4 责任 Responsibilities5 部门/人员Department/Personnel责任 Responsibility质量保证部验证组QA Validation 负责

10、制订与回顾年度SVMP Responsible for preparing and reviewing SVMP 负责制订与回顾各项目验证主计划 Responsible for preparing and reviewing VMP of every project 协调各个验证过程并参与评估待验证项目 Co-ordinate all validation processes and, participates in the assessment of prospective projects for validation requirements. 组织与验证相关培训 Organize th

11、e training for validation. 对验证主计划、方案及报告进行审核并将已完成的验证文件存档 Review validation master plan, validation protocols and reports, archive validation documents.物资管理部Logistic 起草仓库相关项目的用户需求标准、方案与报告 Prepare the URS, validation protocols and reports for projects of warehouse. 进行验证前的评估 System assessment before val

12、idation 按批准的验证方案执行验证 Execute validation activities following approved validation protocol. 数据汇总及对在验证过程产生的问题进行调查 Data collection and problem investigation during validation.工程部Engineering Department 起草公用设施与设备的用户需求标准、方案与报告 Prepare the URS, validation protocols and reports for facilities and utilities.

13、 进行验证前的评估 System assessment before validation 按批准的验证方案执行验证 Execute validation activities following approved validation protocol. 数据汇总及对在验证过程产生的问题进行调查 Data collection and problem investigation during validation.技术部Technical 起草新产品和产品转移的方案与报告 Prepare validation protocols and reports for new products an

14、d products transfer 进行验证前的评估 System assessment before validation 按批准的验证方案执行验证 Execute validation activities following approved validation protocol. 数据汇总及对在验证过程产生的问题进行调查 Data collection and problem investigation during validation. 对工艺验证草案/报告进行批准 Approve process validation protocol and report价值流Value Stream 起草生产设备与工艺的用户需求标准、方案与报告 Prepare product equipment and process URS, validation protocols and reports 进行验证前的评估 System assessment before validation 按批准的验证方案执行验证 Execute validation activities following appr