工厂验证主计划模板---中美天津史克

XXXX公司 Title: 题目 Site Validation Master Plan of XXXX公司 XXXX公司工厂验证主 Document No 文件编号 Document Type 文件类型 Page Number 页码 SVMP_ Site Validation Master Plan 1 of 16 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 approved 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。 Validation Engineer Compliance & 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 Manager Quality Manager Site Director is signing to confirm projects in site and provide the required resources 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 Director Distribution 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 1 2 3 目录Content 31 目的 Objective 2 验证的指导方针与规程Validation Polices and Procedures 4 3 责任 Responsibilities 6 4 验证的时间表与进展 Schedules and Progress 9 5 2007年度完成的验证项目Validation Projects completed in 2007 34 6 2007年度暂停和取消的验证项目Validation Projects on hold and cancelled in 2007 44 7 修订历史Revision History 48 1 目的 Objective 该工厂验证总计划是为了提供一个对XXXX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 that are in process or in plan. 2 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 化学检验验证规程 Chemical Analysis Method Validation 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 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 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 3 责任 Responsibilities 部门/人员 Department/Personnel 责任 Responsibility 质量保证部验证组 QA Validation · 负责制订与回顾年度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 the training for validation. · 对验证主计划、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 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. 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. · 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 and 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 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 the validation. 实验室 QC Lab · 起草分析仪器及分析方法的用户需求标准、方案与报告 Prepare analytical equipment and test methods URS, validation protocols and reports · 进行验证前的评估 System assessment before validation · 完成在验证过程中涉及的检验并提供及时准确的数据 Complete the test in the validation activities and provide timely accurate data. · 按批准的验证方案执行验证 Execute validation activities following approved validation protocols · 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 the validation. 质量保证部QA组 · 确保验证按照批准的方案进行 Ensure the validation is executed according to the validation protocol · 参与对在验证过程中产生的问题的调查 Take part in problem investigation during validation. 质量保证部经理 Head of Quality · 确保所有的验证活动符合XXXX集团及所涉及市场的法规部门的要求 Ensure all the validation activities comply with the and site procedures · 批准SVMP,验证主计划、工艺验证的方案与报告、清洁验证草案和报告、项目cGMP回顾报告、验证总结报告 Approve SVMP, VMP, performance qualification protocol and report, cleaning validation protocol and report, project cGMP review report ,validation summary report 工厂总监 Site Director · 批准SVMP Approve SVMP · 为验证工作提供必要的人力资源及财力资源 Provide the required resources for validation activities 4 验证的时间表与进展 Schedules and Progress 4.1 某车间的验证项目Validation Projects in A workshop 项目 Validation Projects 计划开始与完成日期 Scheduled Date 项目进程Schedule 按计划进行 Progress as per schedule 完成 Completed 推迟 Postponed 依据&备注 Justifications & Comments 开始日期 Starting 完成日期 Ending 2007 2008 6 7 8 9 10 11 12 1 2 3 4 5 2006.11 2007.10 X A 2007.2 2008.12 X 2007.4 2007.12 X B 2007.4 2007.12 X C 4.2某车间回顾验证the Re-validation projects for the A workshop 项目 Validation Projects 计划开始与完成日期 Scheduled Date 项目进程Schedule 按计划进行 Progress as per schedule 完成 Completed 推迟 Postponed 依据&备注 Justifications & Comments 开始日期 Starting 完成日期 Ending 2007 2008 6 7 8 9 10 11 12 1 2 3 4 5 2007.9 2007.12 X 2008.1 2008.3 X 2008.4 2008.6 X 4.2 4.3 物流部新项目Logistics New projects 项目 Validation Projects 计划开始与完成日期 Scheduled Date 项目进程Schedule 按计划进行 Progress as per schedule 完成 Completed 推迟 Postponed 依据&备注 Justifications & Comments 开始日期 Starting 完成日期 Ending 2007 2008 6 7 8 9 10 11 12 1 2 3 4 5 2006.6 2007.12 X 2006.8 2008.12 X 4.4 物流部回顾验证Logistics Re-validation projects 4.3 4.5 工程部回顾验证Engineering Re-validation projects 4.6 工程部支持胶囊价值流回顾验证的项目Engineering support projects for Capsule VS Re-validation projects 依次罗列出所有部门的验证项目。 4.4 4.5 5 5.1 5. 相关部门完成的验证项目 5.1工程部2007年度完成的验证项目Validation Projects completed in 2007--Engineering 项目 Validation Projects 计划开始与完成日期 Scheduled Date 项目进程Schedule 按计划进行 Progress as per schedule 完成 Completed 推迟 Postponed 依据&备注 Justifications & Comments 开始日期 Starting 完成日期 Ending 2007 2006.11 2007.8 X 2006.6 2007.8 X 5.2 质量保证部QA组2007年度完成的验证项目 Validation Projects completed in 2007 -- QA NA 5.3质量保证部实验室2007年度完成的验证项目 Validation Projects completed in 2007-- QC Laboratories 计划开始与完成日期 Scheduled Date 项目进程Schedule 按计划进行 Progress as per schedule 完成 Completed 推迟 Postponed 依据 Justifications & Comments 开始日期 Starting 完成日期 Ending 2007 XXXX产品软膏清洗验证分析方法验证（系统参考编号302052） Fenbid cream cleaning-validation analytical method validation（System Reference NO.302052） 2006.10 2007.3 X XXXX产品清洗验证分析方法验证（系统参考编号302058） XXXX产品 ointment cleaning-validation analytical method validation（System Reference NO.302058） 2007.1 2007.2 X XXXX产品清洗验证分析方法验证（系统参考编号302054） XXXX产品 cleaning-validation analytical method validation（System Reference NO.302054） 2006.11 2007.1 X XXXX产品清洗验证分析方法验证（系统参考编号:302061） XXXX产品cleaning-validation analytical method validation（System Reference NO.:302061） 2007.1 2007.2 X 6. 2007年度暂停和取消的验证项目Validation Projects on hold and cancelled in 2007 6.1 某车间 项目 Validation Projects 计划开始与完成日期 Scheduled Date 项目进程Schedule 按计划进行 Progress as per schedule 完成 Completed 推迟 Postponed 依据 Justifications & Comments 开始日期 Starting 完成日期 Ending 2007 2006.5 2007.3 项目暂停 Hold 2007.3 2007.8 2006年定义保留时间不超过30天, 取消项目 Hold time defined as no more than 30 days in 2006， cancel the project 6.2工程部2007年度暂停和取消的验证项目Validation Projects on hold and cancelled in 2007--Engineering NA 6.3质量保证部QA组2007年度暂停和取消的验证项目 Validation Projects on hold and cancelled in 2007-- QA NA 6.4 质量保证部实验室2007年度暂停和取消的验证项目 Validation Projects on hold and cancelled in 2007-- QC Laboratories 计划开始与完成日期 Scheduled Date 项目进程Schedule 按计划进行 Progress as per schedule 完成 Completed 推迟 Postponed 依据 Justifications & Comments 开始日期 Starting 完成日期 Ending 2007 2007.2 2007.5 项目取消 Project cancelled 2007.2 2007.5 项目取消 Project cancelled 2006.11 2007.5 项目取消 Project cancelled 2007.2 2007.5 项目取消 Project cancelled 7修订历史Revision History 版号 Version No. 批准日期 Approved Date 修订章节 Updated Section 修订简述 Revision Description �Delete �206010 Contac or Fenbid, Contac cleaning validation need to be done for Contac ND project 2007.5-10 �206010 Contac or Fenbid, Contac cleaning validation need to be done for Contac ND project 2007.5-10 �206010 Contac or Fenbid, Contac cleaning validation need to be done for Contac ND project 2007.5-10 �项目号有问题 �206010 Contac or Fenbid, Contac cleaning validation need to be done for Contac ND project 2007.5-10 �Rescheduled for project delay �No any changes �项目号重新和韩静确认 �前后不符 �Can not be finished, need to check �Can not be finished �Can not be finished � Can not be finished �项目号需再确认，时间从2007.2延长至5月 �前后不符 �Delete for finish �Delete for finish �Delete for finish �Need to confirm with Xian zhihua �Delete �Delete �Confirm with Liu da whether can be finished in 2007.3 �Project delayed from 2006.12 to 2007.5 �确认项目号