中美天津史克工厂验证主计划.docx

1、中美天津史克工厂验证主计划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 appro

2、ved document management process that content is consistent with the deliverable definition found in the PSOP1432 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PSOP1432 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。Merry Xiao

3、Validation 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。Jessica HuValidation Assistant ManagerBelinda ChenQuality HeadSite Director is signing to confirm projects in s

4、ite 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。Shirlene M GoldsbroughSite 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

5、of Issue生效日期1231 目的 Objective2 该工厂验证总计划是为了提供一个对中美天津史克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 TSKF. 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 fol

6、lowed 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。Descri

7、be the execution status of validation activities that are in process or in plan.3 验证的指导方针与规程Validation Polices and Procedures 验证类别 Validation Type文件编号 Document No文件名称 Document Name验证生命周期 The Validation Life CycleGQP 1204The Validation Life Cycle 验证生命周期Validation Documentation 验证文件Validation Maintena

8、nce验证维护Impact Assessment 影响评估Design Qualification设计确认Validation Review 验证回顾验证生命周期Validation lifecycleGQMP 1008验证生命周期Validation lifecycle清洗验证Cleaning ValidationGQP 6202Cleaning Validation 清洁验证分析方法与设备验证Analytical Method & Equipment ValidationGQP 7113Validation of Analytical Equipment and Analytical Me

9、thods分析设备与分析方法的验证计算机系统的验证Computer ValidationGQP 1205GQP 3202Computerised System Validation 计算机系统验证Regulated Electronic Records and Signatures?法规要求的电子记录和电子签名注释： GQP = Global Quality Policy (葛兰素史克集团）全球质量方针GQMP=Global Quality Management Process (葛兰素史克集团）全球质量管理规程生产厂关键规程列表如下：Key site procedures are liste

10、d 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 PSOP1432生产设施验证规程Manufacturing Facility ValidationSOP1433验证草案和报告的生成 Generation of Qualification Protocols and ReportsSOP1438设计确认程序Validation Procedure for Design QualificationSOP1439安装确认程序Validation Procedure for

11、Installation QualificationSOP1440运行确认程序Validation Procedure for Operational QualificationSOP1441性能确认程序Validation Procedure for Performance QualificationSOP1442计算机验证方法 Computer Validation ApproachSOP1443清洁验证 Cleaning ValidationSOP1445维护系统的验证状态 Maintaining Systems the Validated Status SOP1446控制系统Contr

12、ol System Validation ApproachSOP1447系统影响性评估System Impact Assessment SOP1451分析仪器验证通则 Analytical Equipment Validation ApproachSOP0832化学检验方法验证规程 Chemical Analysis Method Validation ApproachSOP08344 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 Responsi

13、ble 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 valid

14、ation. 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 validation 按批准的验证方案执行验证

15、 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 ass

16、essment 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

17、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

18、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

19、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

20、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

21、.质量保证部经理QA Head 确保所有的验证活动符合葛兰素史克集团及所涉及市场的法规部门的要求 Ensure all the validation activities comply with the GSK GQPs 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 cG

22、MP 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 activities5 验证的时间表与进展 Schedules and Progress6 6.1 价值流部门的验证项目Validation Projects in Value Streams 6.2 4.1.1 胶囊价值流Capsule VS4.1.1.1胶囊价值流新项目Capsule VS New p

23、rojects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 Ending20072008678910111212345Glatt流化床更换PLC（系统参考编号203111）Glatt fuild bed change PLC（System Reference NO.203111）2006.112007.10X重订时间；大修时间变

24、化Reschedule: Shutdown time change芬必得闭口锅验证（系统参考编号203106）Fenbid close pan Validation（System Reference NO.203106） 2007.22007.12X自动上料机-芬必得装囊自动上料验证（系统参考编号203037）Automatic loading machine used for Fenbid capsule filling Validation（System Reference NO.203037） 2007.42007.12X重订时间；2007年未启动Reschedule; Not star

25、ted in 2007芬必得装囊机提速性能确认（系统参考编号203024-203027）Fenbid filling machine speedup performance qualification（System Reference NO.203024-203027）2007.42007.12X重订时间；2007年未启动Reschedule; Not started in 2007MG2装囊机VR系统验证（系统参考编号203123/203124）VR system validation for MG2 capsule filling(System Reference NO. 203123/2

26、03124)2007.92007.12X新项目New project苏丽丝含量由12% 调整至11.5% （New contac）验证(系统参考编号203003)The content of Surlease adjusts from 12% to 11.5% for New Contac validation. (System Reference NO.203003)2005.72007.8X重订时间；优先级改变Reschedule: priority change.更换成闭口过筛机（系统参考编号203108）Change to closed sieving machine（System R

27、eference NO.203108）2006.112007.6X胶囊清洁验证(系统参考编号206010)Capsule line cleaning validation(System Reference NO.206010)2006.42007.12XContac ND 清洁验证（系统参考编号 206033)Contac ND Cleaning validation(System Reference NO. 206033)2007.52008.6X芬必得制造备料工序何过粉工序的合并（系统参考编号: 203135)Combine dispensing and sieving of Fenbid

28、(System Reference NO.: 203135)2007.62007.8X新项目New project根据Fenbid PUCC,对芬必得制丸档案进行进一步标准化（系统参考编号:204113)Standardization to current BR according to Fenbid PUCC(System Reference NO.: 204113)2007.62007.12X新项目New project康泰克出口项目验证（系统参考编号203117）Contac ND export project validation (System Reference NO.203117)2007.22007.10X新项目New project4.1.1.2胶囊价值流回顾验证Capsule VS Re-validation 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 Ending20072008678910111212345MG3