山東2008年驗證總計劃(已修改)
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【正文】 TRIPARDUS VALIDATION MASTER PLAN/980SHANDONG TRIPARDUS PHARMACEUTICALS CO., LTD.山東瑞博德制藥有限公司VALIDATION DOCUMENT驗證文件Validation Master Plan for the First Phase2008年驗證總計劃Document No./ 文件編號：VD01001Issue No./版本號：1Issue Date/頒發(fā)日期：2007年 12月 28日Written by/起草人: Tony Liu/劉福堂Validation Manager /驗證經(jīng)理Signed/簽名:Date/日期: 年 月 日Authorized by/授權(quán)人:Ray Yu/于瑞清Technical Director/技術(shù)總監(jiān)Signed/簽名:Date/日期: 年 月 日 Document check/審核Audited by審核人Title職位Signature簽名Date日期Jane Chang/常鴻雁Production Director/生產(chǎn)總監(jiān)Production Manager/生產(chǎn)經(jīng)理Tony Liu/劉福堂QA Manager/QA經(jīng)理Rocky Zhao/趙巖Equipment Manager/設(shè)備經(jīng)理Anna Song/宋曉燕QC Manager /QC經(jīng)理Engineering Manager/維修經(jīng)理Storage Manager/倉庫經(jīng)理Long Bao/包龍Commercial Director/商務(wù)總監(jiān)DistributionQA Validation archive (Completed original)QA驗證檔案（完整的原件）Technical Director (Copy)技術(shù)總監(jiān)（復(fù)印件）Engineering Manager (Copy)維修經(jīng)理（復(fù)印件）QC Manager (Copy)QC經(jīng)理（復(fù)印件）Production Manager (Copy)生產(chǎn)經(jīng)理（復(fù)印件）QA Manager (Copy)QA經(jīng)理（復(fù)印件）Packing Manager (Copy)包裝經(jīng)理（復(fù)印件）Validation Manager (Copy)驗證經(jīng)理（復(fù)印件）Commercial Manager (Copy)商務(wù)經(jīng)理（復(fù)印件）Production Director (Copy)生產(chǎn)總監(jiān)（復(fù)印件） Table of Content/目 錄1 Purpose/目的 62 Summary/概述 6 Company introduction and summary of fist stage project / 公司及一期工程項目概述 6 Scope/驗證范圍 6 Validation Policy /驗證方針 63 Validation Organizational Chart and Personnel Responsibilities/驗證組織結(jié)構(gòu)及人員職責 7 Organizational Chart/組織結(jié)構(gòu)圖 7 Validation Committee/驗證委員會 7 Validation/Qualification Team/驗證小組 7 Responsibilities/職責： 7 Responsibilities of Validation Committee/驗證委員會職責 7 Responsibilities of Validation Team/驗證小組職責： 8 All Departmental Managers/所有部門經(jīng)理職責 9 Training /驗證培訓(xùn) 94 The Writing and Approval of Validation Plan, Protocol and Report/驗證計劃、方案、報告的起草審批程序 95 Documentation/文件 9 Content/文件范圍 9 Validation Plan/驗證計劃 9 Validation Protocol/驗證方案 10 Validation Report/驗證報告 10 Validation Certificate/驗證證書 10 Format/文件格式 10 Validation Document numbering/驗證文件的編號 12 Validation/Qualification Archiving驗證/確認歸檔 126 Validation Implementation/驗證實施 12 Safety and Health/安全與健康 12 Validation Classification and Applicable Scope / 本次驗證所用到的驗證分類與適用范圍 12 Prospective Validation / 前驗證 12 Concurrent Validation/同步驗證 13 Revalidation/再驗證 13 Validation Implementation/驗證的實施 14 Validation Project Collection/本次驗證的項目匯總 14 Analytical Methods Validation/
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