工程驗(yàn)證和相關(guān)文件清單

1、工程驗(yàn)證及相關(guān)文件目錄驗(yàn)證主計(jì)劃目錄 （VMP）1INTRODUCTION序言2REFERENCES 參考2.1GMP Rules and guidelines GMP法規(guī)和指南2.2Design documents設(shè)計(jì)文件3FACILITY OVERVIEW 廠房概要3.1Production Areas 生產(chǎn)區(qū)3.2R&D and QC Laboratories 研發(fā)和QC 實(shí)驗(yàn)室3.3Warehouse 倉庫4XXXX MANUFACTURING PROCESS DESCRIPTION XXX生產(chǎn)工藝描述5Areas Classification 區(qū)域分類5.1Cleanline

2、ss Area Classification 潔凈區(qū)分類5.2HVAC Systems 空調(diào)系統(tǒng)5.2.1XXXX Production Areas XXXX生產(chǎn)區(qū)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(shè)施8.1Process Utilities 工藝用公用設(shè)施8.1.1Purified Water 純水8.1.2Process air 工藝用空氣8.1.3Pure Nitrogen純氮8.2TECHNICAL UT

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

4、SEOUS EFFLUENTS HANDLING氣體處理系統(tǒng)8.3.4FIRE WATER SYSTEM消防系統(tǒng)8.3.5FOAM SYSTEM消防泡沫系統(tǒng)8.3.6DRY CHEMICAL SYSTEM干粉系統(tǒng)8.3.7CARBON DIOXIDE SYSTEM二氧化炭系統(tǒng)8.3.8FIRE-FIGHTING SYSTEM SELECTION火災(zāi)報(bào)警系統(tǒng)9CRITICAL PROCESS STEPS and CRITICAL EQUIPMENT 關(guān)鍵的工藝步驟和關(guān)鍵設(shè)備10VALIDATION APPROACH 驗(yàn)證方法10.1GMP Review GMP審核10.2Design Quali

5、fication 設(shè)計(jì)確認(rèn)10.3Factory Acceptance Test 工廠驗(yàn)收測試10.4Mechanical completion 機(jī)械性完工10.5Calibration 校準(zhǔn)10.6Commissioning 調(diào)試10.7Site Acceptance Test 現(xiàn)場驗(yàn)收測試10.8Validation Turn over package (Vtop) 驗(yàn)證文件包10.9Installation Qualification 安裝確認(rèn)10.9.1IQ Acceptance Criteria可接受標(biāo)準(zhǔn)10.10Computer Installation Qualification

6、 計(jì)算機(jī)系統(tǒng)的安裝確認(rèn)10.10.1CIQ acceptance criteria 可接受標(biāo)準(zhǔn)10.11Operational Qualification 運(yùn)行確認(rèn)10.11.1OQ Acceptance Criteria運(yùn)行確認(rèn)的可接受標(biāo)準(zhǔn)10.12Computer Operational Qualification計(jì)算機(jī)運(yùn)行確認(rèn)10.12.1COQ acceptance criteria可接受標(biāo)準(zhǔn)10.13Performance Qualification (PQ) 性能確認(rèn)10.13.1PQ Acceptance Criteria可接受標(biāo)準(zhǔn)10.14Process Validation

7、工藝驗(yàn)證10.14.1Process Validation 工藝驗(yàn)證10.14.2Process Validation Acceptance criteria 工藝驗(yàn)證可接受標(biāo)準(zhǔn)10.15Cleaning Validation 清洗驗(yàn)證10.15.1Cleaning Validation 清洗驗(yàn)證10.15.2Cleaning Validation Acceptance criteria 清洗驗(yàn)證的可接受標(biāo)準(zhǔn)10.16Specific acceptance criteria for Qualification 確認(rèn)工作的特定的可接受標(biāo)準(zhǔn)10.16.1HVAC, LAF and Architec

8、ture Room Finishing空調(diào)系統(tǒng)、層流裝置和房間的裝飾10.16.2Purified Water Production, Storage and Distribution 純化水生產(chǎn)、存儲和分配系統(tǒng)10.16.3Compressed Air 壓縮空氣10.16.4Nitrogen 氮?dú)?0.16.5Scales 稱量裝置10.16.6XXX Melter and Filling solution Preparation TankXXX罐和內(nèi)容物溶液配制罐10.16.7Raw material,XXXX and Filling solution Holding Tanks 原料、X

9、XXX和內(nèi)容物溶液保存罐10.16.8XXXX Base turbo mixer XXXX著色器10.16.9XXX machine XX機(jī)10.16.10Tumble Dryer 轉(zhuǎn)筒式干燥機(jī)10.16.11Drying Tunnel 干燥隧道10.16.12Sorting machine 揀丸機(jī)10.16.13XXXXs Washing machine (Future) 洗丸機(jī)10.16.14XXXX printing machine(Future) XXXX打字機(jī)10.16.15Optical inspection machine目檢機(jī)10.16.16Blistering machine

10、鋁塑包裝機(jī)10.16.17Bottle Filling machine裝瓶機(jī)10.16.18Capping machine 封蓋機(jī)10.16.19Labeling machine貼標(biāo)機(jī)10.16.20Boxing machines裝盒機(jī)10.16.21Cartoning machine裝箱機(jī)11COMMISSIONING & VALIDATION MATRIX調(diào)試和驗(yàn)證矩陣12COMMISSIONING & VALIDATION TIME SCHEDULE驗(yàn)證時(shí)間進(jìn)度表13LIST OF SOP'S標(biāo)準(zhǔn)操作程序清單14QUALIFICATION/VALIDATION M

11、ETHODOLOGY驗(yàn)證方法14.1Protocol Generation方案的形成14.2Protocol Approval方案的批準(zhǔn)14.3Protocol Execution方案的執(zhí)行14.4Review of Execution & Raw Data執(zhí)行和原始數(shù)據(jù)的審核14.5Final Summary Report Generation最終總結(jié)性報(bào)告的形成14.6Change Control變更控制15RESPONSIBILITY職責(zé)15.1General Manager技術(shù)總監(jiān)15.2Quality Assurance/Control經(jīng)理15.3Quality Contro

12、l質(zhì)量控制15.4Project Manager項(xiàng)目經(jīng)理15.5Production Manager 生產(chǎn)經(jīng)理15.6Contractors 合同商16SUPPORT SERVICES支持性服務(wù)16.1Training培訓(xùn)16.2Preventive maintenance預(yù)防性維護(hù)保養(yǎng)16.3Calibration校準(zhǔn)17RE-QUALIFICATION/VALIDATION SCHEDULE重新驗(yàn)證時(shí)間安排18LIST OF ATTACHMENTS 附件清單水系統(tǒng)驗(yàn)證報(bào)告文件清單 Water System設(shè)計(jì)確認(rèn)DQ 1.目的Purpose2.職責(zé) Responsibility3.設(shè)計(jì)參考

13、文件清單 Reference Document List4.設(shè)備描述 System Description 5.設(shè)計(jì)確認(rèn)描述和可接受標(biāo)準(zhǔn) Design Description & Acceptance Ctiteria5.1先決條件Prerequisites5.2設(shè)計(jì)文件確認(rèn)Design Document Verification 5.3安全確認(rèn) Safety Verification 5.4系統(tǒng)溫度的確認(rèn) Temperature Verification 5.5系統(tǒng)流速和生產(chǎn)能力的確認(rèn) Velocity & Capacity Verification 5.6儀表確認(rèn) Inst

14、rument Verification 5.7材料和物體表面的檢查 Material & Surface fininshing Verification 5.8潤滑劑的確認(rèn) Lubricant Verification 5.9排水能力的確認(rèn) Drainablity Verification 5.10系統(tǒng)設(shè)備、管道、聯(lián)結(jié)件結(jié)構(gòu)的確認(rèn) Main Compoment, Piping & Jointer Verification 5.11控制系統(tǒng)的確認(rèn)Control System Verification 5.12系統(tǒng)安裝焊接工作要求的確認(rèn) Welding Verification 5

15、.13系統(tǒng)清洗和鈍化的確認(rèn)Pickling and Passivation Verification 5.14系統(tǒng)在線滅菌能力的確認(rèn)SIP Verification 6.人員的鑒別Personnel Identification 7.偏差報(bào)告Deviation Report8.注釋 Comment 9.偏差清單Deviation List10.附件清單 Attachment List11.回顧和批準(zhǔn) Review & Approval 12.改造和更改控制Change Control 13.設(shè)計(jì)確認(rèn)報(bào)告目錄Index of ReportIQ INDEX目錄1.PURPOSE目的2.RE

16、SPONSIBILITY職責(zé)3.LIST OF REFERENCE DOCUMENT 參考文件清單4.EQUIPMENT DESCRIPTION 設(shè)備描述5.GENERAL METHODLOGY通用方法：6TEST DESCRIPTION AND ACCEPTANCE CRITERIA 測試描述和可接受標(biāo)準(zhǔn)6.1Prerequisites先決條件6.2Documents Verification 文件確認(rèn)6.3Safety Verification 安全確認(rèn)6.4P&ID and Layout Drawing Check P&ID和布局圖的檢查6.5Equipment List

17、 Check 設(shè)備清單檢查6.6Instruments List and Instrument Calibration Verification儀表清單和儀表校準(zhǔn)的核實(shí)6.7Materials and Surface Finishes Check 材料和物體表面的檢查6.8Lubricant Verification 潤滑劑的確認(rèn)6.9Drainability Verification 排水能力的確認(rèn)6.10Utilities Verification 公用設(shè)施的確認(rèn)6.11Control System Electrical Cabinet &Wire Diagram Check控制系

18、統(tǒng)、電氣柜和接線圖的檢查6.12 Software Verification軟件的確認(rèn)6.13 Pickling and Passivation verification酸洗和鈍化的檢查6.14 Welding Check焊接質(zhì)量的檢查7PERSONNAL IDENTIFICATION人員的鑒別8DEVIATION REPORT偏差報(bào)告9COMMENT SECTION注釋10LIST OF DEVIATION 偏差清單11LIST OF ATTACHMENT附件清單12EXECUTION REVIEW AND APPROVAL 回顧和批準(zhǔn)13MODIFICATION & CHANGE

19、CONTROL 改造和更改控制14 INDEX OF TEST REPORT 測試報(bào)告目錄OQ目錄1.PURPOSE目的2.RESPONSIBILITY職責(zé)3.LIST OF REFERENCE DOCUMENT 參考文件清單4.EQUIPMENT DESCRIPTION 設(shè)備描述5.GENERAL METHODLOGY通用方法：6.TEST DESCRIPTION AND ACCEPTANCE CRITERIA 測試描述和可接受標(biāo)準(zhǔn)6.1Prerequisites先決條件6.2Qualification Instruments/Calibration Verification儀器校準(zhǔn)的確認(rèn)6

20、.3Safety Verification安全確認(rèn)6.4Electromagnetic Wave Shield Check電磁波屏蔽的檢查6.5Electrical Power Loss Verification失電的確認(rèn)6.6Loss of Communication通信的丟失6.7Human interface verification人機(jī)界面的確認(rèn)6.8Password verification 口令的確認(rèn)6.9Digital/Analogue Input & output check 數(shù)字/模擬輸入& 輸出的檢查6.10Alarms and Interlocks Che

21、ck報(bào)警和聯(lián)鎖檢查7.FUNCTION TEST功能測試7.1.Production Parameters Verification生產(chǎn)參數(shù)的確認(rèn)7.2.Peak Flow Verification 最大流量確認(rèn)8.PERSONNAL IDENTIFICATION人員的鑒別9.DEVIATION REPORT偏差報(bào)告10.COMMENT SECTION注釋11.LIST OF DEVIATION 偏差清單12.LIST OF ATTACHMENT附件清單13.EXECUTION REVIEW AND APPROVAL 回顧和批準(zhǔn)14.MODIFICATION & CHANGE CONT

22、ROL 改造和更改控制13. INDEX OF TEST REPORT 測試報(bào)告目錄水系統(tǒng)工程驗(yàn)證相關(guān)文件清單序號檢查文件名稱1.設(shè)計(jì)文件機(jī)械部分1.1系統(tǒng)說明1.2P&ID系統(tǒng)圖1.3組件清單（包括儀表清單）1.4設(shè)備數(shù)據(jù)表1.5閥門數(shù)據(jù)表1.6儀表數(shù)據(jù)表1.7管道數(shù)據(jù)表1.8水壓計(jì)算表（管徑和流速）1.9管道平面分布圖1.10管道軸側(cè)圖1.11儲罐平面圖電氣和自控部分1.12電路接線圖和氣動圖（竣工時(shí)提供）1.13硬件設(shè)計(jì)標(biāo)準(zhǔn)（HDS）(控制柜、電路和電氣組件的說明)1.14軟件設(shè)計(jì)標(biāo)準(zhǔn)（SDS）(軟件配置、控制功能、報(bào)警聯(lián)鎖等說明)1.15輸入/輸出清單1.16功能邏輯圖1.17

23、功能說明2.竣工文件2.1系統(tǒng)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(zhì)證明（管道、閥門等）（包括材料種類和表面粗糙度等）2.4焊接文件（包括設(shè)備和焊工證書、焊接打印記錄、焊樣焊點(diǎn)檢查記錄、焊接規(guī)程）2.5儀表校準(zhǔn)證書2.6坡度檢查規(guī)程和報(bào)告2.7水壓測試規(guī)程和報(bào)告2.8管道清洗規(guī)程和報(bào)告2.9管道鈍化規(guī)程和報(bào)告2.10輸入輸出測試報(bào)告2.11報(bào)警聯(lián)鎖測試報(bào)告2.12單機(jī)調(diào)試報(bào)告2.13系統(tǒng)運(yùn)行測試報(bào)告（功能測試）2.14備品備件清單2.15軟件備份3.質(zhì)量控制文件3.1工程時(shí)間進(jìn)度表3.2需求追溯表3.3風(fēng)險(xiǎn)分析3.4FAT (如儲罐)3.5SAT空調(diào)系統(tǒng)驗(yàn)證報(bào)告文件清單

24、 HVAC設(shè)計(jì)確認(rèn)DQ目錄 INDEX1.目的Purpose2.職責(zé)Responsibility3.設(shè)計(jì)參考文件清單Reference Documnet4.設(shè)備描述 System Description 5.設(shè)計(jì)確認(rèn)描述和可接受標(biāo)準(zhǔn) DQ Description & Acceptance Criteria5.1先決條件Prerequisites5.2設(shè)計(jì)文件確認(rèn) Design Document Verification 5.3安全確認(rèn) Safety Verification 5.4房間參數(shù)的確認(rèn) Room Specification Verification 5.5系統(tǒng)冷負(fù)荷的核算 C

25、ooling Capacity Verification 5.6系統(tǒng)熱負(fù)荷的核算 Heating Capacity Verification 5.7系統(tǒng)加/除濕量的核算 DE/Humidification Verification5.8空調(diào)機(jī)組性能的確認(rèn) AHU Speicification Verification 5.9系統(tǒng)風(fēng)管和風(fēng)口布置圖（及高效過濾器）的確認(rèn) Air Duct & HEPA Layout5.10空調(diào)控制系統(tǒng)的確認(rèn) Control System Verification 5.11儀器儀表的確認(rèn) Instrument Verification 5.12高效過濾器DO

26、P測試設(shè)計(jì)的確認(rèn) DOP design Verification 5.13空調(diào)系統(tǒng)GMP的設(shè)計(jì)審核 GMP Review6.人員的鑒別 Personnel Identification 7.偏差報(bào)告 Deviation Report8.注釋Comment Section 9.偏差清單 Deviation List10.附件清單 Attachment List11.回顧和批準(zhǔn) Reviesw & Approval12.改造和更改控制 Change Control 14. 設(shè)計(jì)確認(rèn)報(bào)告目錄Index of Report設(shè)計(jì)確認(rèn)報(bào)告1 先決條件Prerequisites設(shè)計(jì)確認(rèn)報(bào)告2 設(shè)計(jì)文

27、件確認(rèn)Design Document Verification設(shè)計(jì)確認(rèn)報(bào)告3 安全確認(rèn)Safety Verification設(shè)計(jì)確認(rèn)報(bào)告4 房間參數(shù)的確認(rèn)Room Specification Verification設(shè)計(jì)確認(rèn)報(bào)告5 系統(tǒng)冷負(fù)荷的核算Cooling Capacity Verification設(shè)計(jì)確認(rèn)報(bào)告6 系統(tǒng)熱負(fù)荷的核算Heating Capacity Verification設(shè)計(jì)確認(rèn)報(bào)告7 系統(tǒng)加/除濕量的核算DE/Humidification Verification設(shè)計(jì)確認(rèn)報(bào)告8 空調(diào)機(jī)組性能的確認(rèn)AHU Speicification Verification設(shè)計(jì)確認(rèn)報(bào)告

28、9 系統(tǒng)風(fēng)管和風(fēng)口布置圖（及高效過濾器）的確認(rèn)Air Duct & HEPA Layout設(shè)計(jì)確認(rèn)報(bào)告10 空調(diào)控制系統(tǒng)的確認(rèn)Control System Verification設(shè)計(jì)確認(rèn)報(bào)告11 儀器儀表的確認(rèn)Instrument Verification設(shè)計(jì)確認(rèn)報(bào)告12 高效過濾器DOP測試設(shè)計(jì)的確認(rèn) DOP design Verification設(shè)計(jì)確認(rèn)報(bào)告13 空調(diào)系統(tǒng)GMP 的設(shè)計(jì)審核GMP Review設(shè)計(jì)確認(rèn)報(bào)告14 人員的鑒別Personnel Identification設(shè)計(jì)確認(rèn)報(bào)告15 偏差報(bào)告Deviation Report設(shè)計(jì)確認(rèn)報(bào)告16 注釋表Comment

29、Section設(shè)計(jì)確認(rèn)報(bào)告17 偏差清單 Deviation List設(shè)計(jì)確認(rèn)報(bào)告18 附件清單 Attachment List設(shè)計(jì)確認(rèn)報(bào)告 19 批準(zhǔn) ApprovalIQ 目錄1.PURPOSE目的2.RESPONSIBILITY職責(zé)3.LIST OF REFERENCE DOCUMENT 參考文件清單4.EQUIPMENT DESCRIPTION 設(shè)備描述5.GENERAL METHODLOGY通用方法：6.TEST DESCRIPTION AND ACCEPTANCE CRITERIA 測試描述和可接受標(biāo)準(zhǔn)6.1.Prerequisites先決條件6.2.Documents Verif

30、ication 文件確認(rèn)6.3.Safety Verification 安全確認(rèn)6.4.P&ID and Layout Drawing Check P&ID和布局圖的檢查6.5.Equipment List Check 設(shè)備清單檢查6.6.Instruments List and Instrument Calibration Verification儀表清單和儀表校準(zhǔn)的核實(shí)6.7.HEPA Filter Layout Check 高效過濾器的檢查6.8.Utilities Verification 公用設(shè)施的確認(rèn)6.9.Control System Electrical Cab

31、inet &Wire Diagram Check控制系統(tǒng)、電氣柜和接線圖的檢查6.10.Control System Software Verification軟件的確認(rèn)6.11.Control System Hardware Verification硬件的確認(rèn)6.12.GMP REVIEW GMP的審核7.PERSONNAL IDENTIFICATION人員的鑒別8.DEVIATION REPORT偏差報(bào)告9.COMMENT SECTION注釋10.LIST OF DEVIATION 偏差清單11.LIST OF ATTACHMENT附件清單12.EXECUTION REVIEW A

32、ND APPROVAL 回顧和批準(zhǔn)13.MODIFICATION & CHANGE CONTROL 改造和更改控制14.INDEX OF TEST REPORT 測試報(bào)告目錄OQ目錄1.PURPOSE目的2.RESPONSIBILITY職責(zé)3.LIST OF REFERENCE DOCUMENT 參考文件清單4.EQUIPMENT DESCRIPTION 設(shè)備描述5.GENERAL METHODLOGY通用方法：6.TEST DESCRIPTION AND ACCEPTANCE CRITERIA 測試描述和可接受標(biāo)準(zhǔn)6.1Prerequisites先決條件6.2Qualificatio

33、n Instruments/Calibration Verification驗(yàn)證儀器校準(zhǔn)的確認(rèn)6.3Sequence Check順序確認(rèn)6.4Electromagnetic Wave Shield Check電磁波屏蔽的檢查6.5Black Out Verification 中斷的確認(rèn)6.6Loss of Communication通信的丟失6.7Human interface verification人機(jī)界面的確認(rèn)6.8Password verification 口令的確認(rèn)6.9Digital/Analogue Input & output check 數(shù)字/模擬輸入& 輸出的檢查6.10Alarms and Interlocks Check報(bào)警和聯(lián)鎖檢查7.ROOM TEST 房間測試7.1.HEPA Fi