1、.工程驗證及相關文件目錄驗證主方案目錄 VMP1INTRODUCTION序言2REFERENCES 參考2.1GMP Rules and guidelines GMP法規和指南2.2Design documents設計文件3FACILITY OVERVIEW 廠房概要3.1Production Areas 生產區3.2R&D and QC Laboratories 研發和QC 實驗室3.3Warehouse 倉庫4XXXX MANUFACTURING PROCESS DESCRIPTION XXX生產工藝描述5Areas Classification 區域分類5.1Cleanlines

2、s Area Classification 干凈區分類5.2HVAC Systems 空調系統5.2.1XXXX Production Areas XXXX生產區6Personnel and material Flow 人流和物流6.1Personnel flow 人流6.2Material Flow 物流7Pressure Lay Out 壓力分布圖8UTILITIES 公用設施8.1Process Utilities 工藝用公用設施8.1.1Purified Water 純水8.1.2Process air 工藝用空氣8.1.3Pure Nitrogen純氮8.2TECHNICAL UTI

3、LITIES 技術用公用設施8.2.1POTABLE WATER (W) SYSTEM飲用水系統8.2.2HOT WATER FOR HVAC (HWS)空調用熱水系統8.2.3HOT SANITARY WATER (HSWS)衛生型熱水8.2.4MEDIUM AND LOW PRESSURE STEAM中壓和低壓蒸汽8.2.5PRESSED AIR壓縮空氣8.2.6CHILLED WATER冷凍水8.3SUPPORT SYSTEMS 配套系統8.3.1PROCESS SEWER工藝廢水8.3.2EQUALISATION/NEUTRALISATION SYSTEM中和系統8.3.3GASEOU

4、S EFFLUENTS HANDLING氣體處理系統8.3.4FIRE WATER SYSTEM消防系統8.3.5FOAM SYSTEM消防泡沫系統8.3.6DRY CHEMICAL SYSTEM干粉系統8.3.7CARBON DIOXIDE SYSTEM二氧化炭系統8.3.8FIRE-FIGHTING SYSTEM SELECTION火災報警系統9CRITICAL PROCESS STEPS and CRITICAL EQUIPMENT 關鍵的工藝步驟和關鍵設備10VALIDATION APPROACH 驗證方法10.1GMP Review GMP審核10.2Design Qualifica

5、tion 設計確認10.3Factory Acceptance Test 工廠驗收測試10.4Mechanical pletion 機械性完工10.5Calibration 校準10.6missioning 調試10.7Site Acceptance Test 現場驗收測試10.8Validation Turn over package (Vtop) 驗證文件包10.9Installation Qualification 安裝確認10.9.1IQ Acceptance Criteria可承受標準10.10puter Installation Qualification 計算機系統的安裝確認10

6、.10.1CIQ acceptance criteria 可承受標準10.11Operational Qualification 運行確認10.11.1OQ Acceptance Criteria運行確認的可承受標準10.12puter Operational Qualification計算機運行確認10.12.1COQ acceptance criteria可承受標準10.13Performance Qualification (PQ) 性能確認10.13.1PQ Acceptance Criteria可承受標準10.14Process Validation 工藝驗證10.14.1Proce

7、ss Validation 工藝驗證10.14.2Process Validation Acceptance criteria 工藝驗證可承受標準10.15Cleaning Validation 清洗驗證10.15.1Cleaning Validation 清洗驗證10.15.2Cleaning Validation Acceptance criteria 清洗驗證的可承受標準10.16Specific acceptance criteria for Qualification 確認工作的特定的可承受標準10.16.1HVAC, LAF and Architecture Room Finish

8、ing空調系統、層流裝置和房間的裝飾10.16.2Purified Water Production, Storage and Distribution 純化水生產、存儲和分配系統10.16.3pressed Air 壓縮空氣10.16.4Nitrogen 氮氣10.16.5Scales 稱量裝置10.16.6XXX Melter and Filling solution Preparation TankXXX罐和內容物溶液配制罐10.16.7Raw material,XXXX and Filling solution Holding Tanks 原料、XXXX和內容物溶液保存罐10.16.8

9、XXXX Base turbo mixer XXXX著色器10.16.9XXX machine XX機10.16.10Tumble Dryer 轉筒式枯燥機10.16.11Drying Tunnel 枯燥隧道10.16.12Sorting machine 揀丸機10.16.13XXXXs Washing machine (Future) 洗丸機10.16.14XXXX printing machine(Future) XXXX打字機10.16.15Optical inspection machine目檢機10.16.16Blistering machine鋁塑包裝機10.16.17Bottle

10、 Filling machine裝瓶機10.16.18Capping machine 封蓋機10.16.19Labeling machine貼標機10.16.20Boxing machines裝盒機10.16.21Cartoning machine裝箱機11MISSIONING & VALIDATION MATRIX調試和驗證矩陣12MISSIONING & VALIDATION TIME SCHEDULE驗證時間進度表13LIST OF SOP'S標準操作程序清單14QUALIFICATION/VALIDATION METHODOLOGY驗證方法14.1Protoco

11、l Generation方案的形成14.2Protocol Approval方案的批準14.3Protocol Execution方案的執行14.4Review of Execution & Raw Data執行和原始數據的審核14.5Final Summary Report Generation最終總結性報告的形成14.6Change Control變更控制15RESPONSIBILITY職責15.1General Manager技術總監15.2Quality Assurance/Control經理15.3Quality Control質量控制15.4Project Manager工

12、程經理15.5Production Manager 生產經理15.6Contractors 合同商16SUPPORT SERVICES支持性效勞16.1Training培訓16.2Preventive maintenance預防性維護保養16.3Calibration校準17RE-QUALIFICATION/VALIDATION SCHEDULE重新驗證時間安排18LIST OF ATTACHMENTS 清單水系統驗證報告文件清單 Water System設計確認DQ1.目的Purpose2.職責 Responsibility3.設計參考文件清單 Reference Document List

13、4.設備描述 System Description 5.設計確認描述和可承受標準 Design Description & Acceptance Ctiteria5.1先決條件Prerequisites5.2設計文件確認Design Document Verification 5.3平安確認 Safety Verification 5.4系統溫度確實認 Temperature Verification 5.5系統流速和生產能力確實認Velocity & Capacity Verification 5.6儀表確認 Instrument Verification 5.7材料和物體外

14、表的檢查 Material & Surface fininshing Verification 5.8潤滑劑確實認 Lubricant Verification 5.9排水能力確實認 Drainablity Verification 5.10系統設備、管道、聯結件構造確實認 Main poment, Piping & Jointer Verification 5.11控制系統確實認Control System Verification 5.12系統安裝焊接工作要求確實認 Welding Verification 5.13系統清洗和鈍化確實認Pickling and Passiv

15、ationVerification 5.14系統在線滅菌能力確實認SIP Verification 6.人員的鑒別Personnel Identification 7.偏差報告Deviation Report8.注釋 ment 9.偏差清單Deviation List10.清單 Attachment List11.回憶和批準 Review & Approval 12.改造和更改控制Change Control 13.設計確認報告目錄Index of ReportIQ INDEX目錄1.PURPOSE目的2.RESPONSIBILITY職責3.LIST OF REFERENCE DOCU

16、MENT 參考文件清單4.EQUIPMENT DESCRIPTION 設備描述5.GENERAL METHODLOGY通用方法：6TEST DESCRIPTION AND ACCEPTANCE CRITERIA 測試描述和可承受標準6.1Prerequisites先決條件6.2Documents Verification 文件確認6.3Safety Verification 平安確認6.4P&ID and Layout Drawing Check P&ID和布局圖的檢查6.5Equipment List Check 設備清單檢查6.6Instruments List and I

17、nstrument Calibration Verification儀表清單和儀表校準的核實6.7Materials and Surface Finishes Check 材料和物體外表的檢查6.8Lubricant Verification 潤滑劑確實認6.9Drainability Verification 排水能力確實認6.10Utilities Verification 公用設施確實認6.11Control System Electrical Cabinet &Wire Diagram Check控制系統、電氣柜和接線圖的檢查6.12 Software Verification

18、軟件確實認6.13 Pickling and Passivation verification酸洗和鈍化的檢查6.14 Welding Check焊接質量的檢查7PERSONNAL IDENTIFICATION人員的鑒別8DEVIATION REPORT偏差報告9MENT SECTION注釋10LIST OF DEVIATION 偏差清單11LIST OF ATTACHMENT清單12EXECUTION REVIEW AND APPROVAL 回憶和批準13MODIFICATION & CHANGE CONTROL 改造和更改控制14 INDEX OF TEST REPORT 測試報告

19、目錄OQ目錄1.PURPOSE目的2.RESPONSIBILITY職責3.LIST OF REFERENCE DOCUMENT 參考文件清單4.EQUIPMENT DESCRIPTION 設備描述5.GENERAL METHODLOGY通用方法：6.TEST DESCRIPTION AND ACCEPTANCE CRITERIA 測試描述和可承受標準6.1Prerequisites先決條件6.2Qualification Instruments/Calibration Verification儀器校準確實認6.3Safety Verification平安確認6.4Electromagnetic

20、 Wave Shield Check電磁波屏蔽的檢查6.5Electrical Power Loss Verification失電確實認6.6Loss of munication通信的喪失6.7Human interface verification人機界面確實認6.8Password verification 口令確實認6.9Digital/Analogue Input & output check 數字/模擬輸入& 輸出的檢查6.10Alarms and Interlocks Check報警和聯鎖檢查7.FUNCTION TEST功能測試7.1.Production Par

21、ameters Verification生產參數確實認7.2.Peak Flow Verification 最大流量確認8.PERSONNAL IDENTIFICATION人員的鑒別9.DEVIATION REPORT偏差報告10.MENT SECTION注釋11.LIST OF DEVIATION 偏差清單12.LIST OF ATTACHMENT清單13.EXECUTION REVIEW AND APPROVAL 回憶和批準14.MODIFICATION & CHANGE CONTROL 改造和更改控制13. INDEX OF TEST REPORT 測試報告目錄水系統工程驗證相關

22、文件清單序號檢查文件名稱1.設計文件機械局部1.1系統說明1.2P&ID系統圖1.3組件清單包括儀表清單1.4設備數據表1.5閥門數據表1.6儀表數據表1.7管道數據表1.8水壓計算表管徑和流速1.9管道平面分布圖1.10管道軸側圖1.11儲罐平面圖電氣和自控局部1.12電路接線圖和氣動圖竣工時提供1.13硬件設計標準HDS(控制柜、電路和電氣組件的說明)1.14軟件設計標準SDS(軟件配置、控制功能、報警聯鎖等說明)1.15輸入/輸出清單1.16功能邏輯圖1.17功能說明2.竣工文件2.1系統操作手冊2.2組件的文件資料如泵、閥門、傳感器等2.3材質證明管道、閥門等包括材料種類和外表

23、粗糙度等2.4焊接文件包括設備和焊工證書、焊接打印記錄、焊樣焊點檢查記錄、焊接規程2.5儀表校準證書2.6坡度檢查規程和報告2.7水壓測試規程和報告2.8管道清洗規程和報告2.9管道鈍化規程和報告2.10輸入輸出測試報告2.11報警聯鎖測試報告2.12單機調試報告2.13系統運行測試報告功能測試2.14備品備件清單2.15軟件備份3.質量控制文件3.1工程時間進度表3.2需求追溯表3.3風險分析3.4FAT (如儲罐)3.5SAT空調系統驗證報告文件清單 HVAC設計確認DQ目錄 INDEX1.目的Purpose2.職責Responsibility3.設計參考文件清單Reference Doc

24、umnet4.設備描述 System Description 5.設計確認描述和可承受標準 DQ Description & Acceptance Criteria5.1先決條件Prerequisites5.2設計文件確認 Design Document Verification 5.3平安確認 Safety Verification 5.4房間參數確實認 Room Specification Verification 5.5系統冷負荷的核算 Cooling Capacity Verification 5.6系統熱負荷的核算 Heating Capacity Verification

25、5.7系統加/除濕量的核算 DE/Humidification Verification5.8空調機組性能確實認 AHU Speicification Verification 5.9系統風管和風口布置圖及高效過濾器確實認 Air Duct & HEPA Layout5.10空調控制系統確實認 Control System Verification 5.11儀器儀表確實認 Instrument Verification 5.12高效過濾器DOP測試設計確實認 DOP design Verification 5.13空調系統GMP的設計審核 GMP Review6.人員的鑒別 Perso

26、nnel Identification 7.偏差報告 Deviation Report8.注釋ment Section 9.偏差清單 Deviation List10.清單 Attachment List11.回憶和批準 Reviesw & Approval12.改造和更改控制 Change Control 14. 設計確認報告目錄Index of Report設計確認報告1 先決條件Prerequisites設計確認報告2 設計文件確認Design Document Verification設計確認報告3 平安確認Safety Verification設計確認報告4 房間參數確實認R

27、oom Specification Verification設計確認報告5 系統冷負荷的核算Cooling Capacity Verification設計確認報告6 系統熱負荷的核算Heating Capacity Verification設計確認報告7 系統加/除濕量的核算DE/Humidification Verification設計確認報告8 空調機組性能確實認AHU Speicification Verification設計確認報告9 系統風管和風口布置圖及高效過濾器確實認Air Duct & HEPA Layout設計確認報告10 空調控制系統確實認Control Syste

28、m Verification設計確認報告11 儀器儀表確實認Instrument Verification設計確認報告12 高效過濾器DOP測試設計確實認DOP design Verification設計確認報告13 空調系統GMP 的設計審核GMP Review設計確認報告14 人員的鑒別Personnel Identification設計確認報告15 偏差報告Deviation Report設計確認報告16 注釋表ment Section設計確認報告17 偏差清單 Deviation List設計確認報告18 清單 Attachment List設計確認報告 19 批準 ApprovalI

29、Q 目錄1.PURPOSE目的2.RESPONSIBILITY職責3.LIST OF REFERENCE DOCUMENT 參考文件清單4.EQUIPMENT DESCRIPTION 設備描述5.GENERAL METHODLOGY通用方法：6.TEST DESCRIPTION AND ACCEPTANCE CRITERIA 測試描述和可承受標準6.1.Prerequisites先決條件6.2.Documents Verification 文件確認6.3.Safety Verification 平安確認6.4.P&ID and Layout Drawing Check P&ID

30、和布局圖的檢查6.5.Equipment List Check 設備清單檢查6.6.Instruments List and Instrument Calibration Verification儀表清單和儀表校準的核實6.7.HEPA Filter Layout Check 高效過濾器的檢查6.8.Utilities Verification 公用設施確實認6.9.Control System Electrical Cabinet &Wire Diagram Check控制系統、電氣柜和接線圖的檢查6.10.Control System Software Verification軟件

31、確實認6.11.Control System Hardware Verification硬件確實認6.12.GMP REVIEW GMP的審核7.PERSONNAL IDENTIFICATION人員的鑒別8.DEVIATION REPORT偏差報告9.MENT SECTION注釋10.LIST OF DEVIATION 偏差清單11.LIST OF ATTACHMENT清單12.EXECUTION REVIEW AND APPROVAL 回憶和批準13.MODIFICATION & CHANGE CONTROL 改造和更改控制14.INDEX OF TEST REPORT 測試報告目錄

32、. v.OQ目錄1.PURPOSE目的2.RESPONSIBILITY職責3.LIST OF REFERENCE DOCUMENT 參考文件清單4.EQUIPMENT DESCRIPTION 設備描述5.GENERAL METHODLOGY通用方法：6.TEST DESCRIPTION AND ACCEPTANCE CRITERIA 測試描述和可承受標準6.1Prerequisites先決條件6.2Qualification Instruments/Calibration Verification驗證儀器校準確實認6.3Sequence Check順序確認6.4Electromagnetic Wave Shield Check電磁波屏蔽的檢查6.5Black Out Verification 中斷確實認6.6Loss of munication通信的喪失6.7Human interface verification人機界面確實認6.8Password verification 口令確實認6.9Digital/Analogue Input & output check 數字/模擬輸入& 輸出的檢查6.10Alarms and Interlocks Check報警和聯鎖檢查7.ROOM TEST 房間測試7.1