中美天津史克工厂验证主计划.docx

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 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 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。 Jessica Hu Validation Assistant Manager Belinda Chen Quality Head 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。 Shirlene M Goldsbrough  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 (CV) 由谁生效（法规和验证组） Date of Issue 生效日期 1 2 3 1 目的 Objective .............................................................. 4 2 验证的指导方针与规程 Validation Polices and Procedures ...................... 5 3 责任 Responsibilities ....................................................... 9 4 验证的时间表与进展 Schedules and Progress ................................. 14 2007 年度完成的验证项目 Validation Projects completed in 2007 ............... 63 2007 年度暂停和取消的验证项目 Validation Projects on hold and cancelled in 2007 88 7 修订历史 Revision History .................................................. 95 目的 Objective 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: 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