山东2008年验证总计划--山东瑞博德制药有限公司

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SHANDONG TRIPARDUS PHARMACEUTICALS CO., LTD.

山东瑞博德制药有限公司

VALIDATION DOCUMENT

验证文件

Validation Master Plan for the First Phase 2008年验证总计划

Document No./ 文件编号： VD01001 Issue No./版本号： 1 Issue Date/颁发日期： 2007年 12月 28日

Written by/起草人: Tony Liu/刘福堂

Validation Manager /验证经理

Date/日期:

Signed/签名:

年 月 日 Date/日期:

Signed/签名:

Authorized by/授权人: Ray Yu/于瑞清

TRIPARDUS VALIDATION MASTER PLAN/瑞博德验证主计划

Technical Director/技术总监 年 月 日

VD01001

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TRIPARDUS VALIDATION MASTER PLAN/瑞博德验证主计划

Document check/审核

Audited by审核人 Jane Chang/常鸿雁 Tony Liu/刘福堂 Rocky Zhao/赵岩 Anna Song/宋晓燕 Long Bao/包龙 Title职位 Production Director/生产总监 Production Manager/生产经理 QA Manager/QA经理 Equipment Manager/设备经理 QC Manager /QC经理 Engineering Manager/维修经理 Storage Manager/仓库经理 Commercial Director/商务总监 Signature签名 Date日期 Distribution QA Validation archive (Completed original) QA验证档案（完整的原件） Engineering Manager (Copy) 维修经理（复印件） Production Manager (Copy) 生产经理（复印件） Packing Manager (Copy) 包装经理（复印件） Commercial Manager (Copy) 商务经理（复印件）

Technical Director (Copy) 技术总监（复印件） QC Manager (Copy) QC经理（复印件） QA Manager (Copy) QA经理（复印件） Validation Manager (Copy) 验证经理（复印件） Production Director (Copy) 生产总监（复印件）

VD01001

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TRIPARDUS VALIDATION MASTER PLAN/瑞博德验证主计划

Table of Content/目 录

1 Purpose/目的 .......................................................................................................................................... 7 2 Summary/概述 ....................................................................................................................................... 7

2.1 Company introduction and summary of fist stage project / 公司及一期工程项目概述 ............. 7 2.2 Scope/验证范围 ............................................................................................................................ 7 2.3 Validation Policy /验证方针 ......................................................................................................... 7 3 Validation Organizational Chart and Personnel Responsibilities/验证组织结构及人员职责 ........ 8

3.1 Organizational Chart/组织结构图 ................................................................................................ 8 3.2 Validation Committee/验证委员会 .............................................................................................. 8 3.3 Validation/Qualification Team/验证小组 ..................................................................................... 8 3.4 Responsibilities/职责： ................................................................................................................ 8

3.4.1 Responsibilities of Validation Committee/验证委员会职责 ................................ 8

3.4.2 3.4.3

Responsibilities of Validation Team/验证小组职责： ......................................... 9 All Departmental Managers/所有部门经理职责 ................................................ 10

3.5 Training /验证培训 ..................................................................................................................... 10

4 The Writing and Approval of Validation Plan, Protocol and Report/验证计划、方案、报告的起草审批程序.................................................................................................................................................. 10 5 Documentation/文件 ........................................................................................................................... 10

5.1 Content/文件范围 ....................................................................................................................... 10

5.1.1 Validation Plan/验证计划 ................................................................................... 10

5.1.2 5.1.3 5.1.4

Validation Protocol/验证方案 ............................................................................. 11 Validation Report/验证报告 ................................................................................ 11 Validation Certificate/验证证书 .......................................................................... 11

5.2 Format/文件格式 ........................................................................................................................ 11 5.3 Validation Document numbering/验证文件的编号 ................................................................... 13 5.4 Validation/Qualification Archiving验证/确认归档 ................................................................... 13 6 Validation Implementation/验证实施 ................................................................................................ 13

6.1 Safety and Health/安全与健康 ................................................................................................... 13 6.2 Validation Classification and Applicable Scope / 本次验证所用到的验证分类与适用范围 .. 13

6.2.1 Prospective Validation / 前验证 ......................................................................... 13

6.2.2 6.2.3

Concurrent Validation/同步验证......................................................................... 14 Revalidation/再验证 ............................................................................................ 14

6.3 Validation Implementation/验证的实施 .................................................................................... 14

6.4 Validation Project Collection/本次验证的项目汇总 ................................................................. 14

6.4.1 Analytical Methods Validation/分析方法学 ....................................................... 15

6.4.2 6.4.3 6.4.4 6.4.5 6.4.6

Facilities/设施 ...................................................................................................... 15 Instruments and equipments/仪器设备 ............................................................... 15 Process/工艺 ........................................................................................................ 16 Equipment Cleaning/设备清洁 ........................................................................... 17 Computerized system/计算机化系统 .................................................................. 17

6.5 Schedule/本次验证的时间计划安排 ......................................................................................... 18

VD01001

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