【正文】 Validation 編號 : No. OQ542JK1 HVAC 系統(tǒng) 運(yùn)行確認(rèn) OQ of HVAC 頁碼 : Page 1 of 37 株洲千金藥業(yè)股份有限公司 女性健康產(chǎn)業(yè)基地 綜合廠房 HVAC 系統(tǒng)運(yùn)行確認(rèn) （ JK1 系統(tǒng)） 協(xié)多力驗(yàn)證部 2020 年 9 月 Validation 編號 : No. OQ542JK1 HVAC 系統(tǒng) 運(yùn)行確認(rèn) OQ of HVAC 頁碼 : Page 2 of 37 HVAC 系統(tǒng)運(yùn)行確認(rèn)方案 OQ Protocol Of HVAC 制訂人： Author 制訂部門： Department 審核人： Reviewed By 審核日期： Reviewed Date 協(xié)多力公司 驗(yàn)證部 Validate Department 審核人： Reviewed By 審核日期： Reviewed Date 批準(zhǔn)人： Approved By 批準(zhǔn)日期： Approved Date 株洲千金藥業(yè)股份有限公司 分發(fā)部門： Distributed To 替換文件： Replaced For 修訂記錄： Revised Record Validation 編號 : No. OQ542JK1 HVAC 系統(tǒng) 運(yùn)行確認(rèn) OQ of HVAC 頁碼 : Page 3 of 37 目錄 1. 通則 QENNRAL RULE .............................................................................................................5 目的 Purpose...................................................................................................................5 范圍 Scope .....................................................................................................................5 文件管理規(guī)范 Good Document Practice ............................................................................5 各方職責(zé) ........................................................................................................................7 協(xié)多力公司的職責(zé) The Responsibilities Of Suntec Include The Followings: .............................................................................................................................7 株洲千金藥業(yè)股份有限公司 的職責(zé)包括但不僅僅限于以下 :The Responsibilities Of qianjin Include,But Not Limited To:........................................................7 2. 系統(tǒng)的描述 DESCRIPTION SYSTEM ........................................................................................9 2． 1 JK1系統(tǒng)的系統(tǒng)描述 Description for JK1 System ..........................................................9 2． 2 JK1系統(tǒng)的控制系統(tǒng)描述 Contorl System Description for JK1 System ........................... 10 2． 3 設(shè)計(jì)要求： Design Requirements................................................................................. 13 2． 4 GMP適用要求： GMP According Requirements ............................................................ 13 3. 測試描述和可接受標(biāo)準(zhǔn) TEST DESCRIPTION AND ACCEPTANCE CRITERIA .......................... 14 先決條件 Requisites....................................................................................................... 14 驗(yàn)證儀器校準(zhǔn)的確認(rèn) Validation Instrument Calibration Verification .................................... 14 口令的確認(rèn) Password Verification ................................................................................... 15 房間送風(fēng)量和換氣次數(shù) Room Supply Flow Rate And Air Changes .................................... 15 房間壓差 Room Differential Pressure .............................................................................. 16 房間溫度和相對濕度 Temperature And Relative Humidity In Room ................................... 17 房間潔凈度的測試（靜態(tài)） Non Viable Particle Count Of Room “At Rest” ......................... 18 人員的確認(rèn) PERSONNEL IDENTIFICATION ................................................................... 20 4. 偏差報(bào)告 DEVIATION REPORT.............................................................................................. 20 5. 注釋 COMMENT SECTION .................................................................................................... 20 6. 偏差清單 LIST OF DEVIATION ............................................................................................... 20 7. 附件清單 LIST OF ATTACHMENT .......................................................................................... 21 8. 審核和批準(zhǔn) EXECUTION REVIEW AND APPROVAL ........................................................... 21 9. 改造和更改控制 MODIFY AND CHANGE CONTROL ............................................................... 21 10. 測試報(bào)告目錄 INDEX OF TEST REPORT............................................................................. 22 Validation 編號 : No. OQ542JK1 HVAC 系統(tǒng) 運(yùn)行確認(rèn) OQ of HVAC 頁碼 : Page 4 of 37 TEST REPORT 1 測試報(bào)告 1 ................................................................................................. 23 TEST REPORT 2 測試報(bào)告 2 ................................................................................................. 24 TEST REPORT 3 測試報(bào)告 3 ................................................................................................. 25 TEST REPORT 5 測試報(bào)告 5 ................................................................................................. 28 TEST REPORT 6 測試報(bào)告 6 ................................................................................................. 29 TEST REPORT 7 測試報(bào)告 7 ................................................................................................. 30 TEST REPORT 8 測試報(bào)告 8 ................................................................................................. 31 TEST REPORT 9 測試報(bào)告 9 ................................................................................................. 33 TEST REPORT 10 測試報(bào)告 10 ............................................................................................. 34 TEST REPORT 11 測試報(bào)告 11 ............................................................................................. 35 TEST REPORT 12 測試報(bào)告 12 ............................................................................................. 36 TEST REPORT 12 測試報(bào)告 12 ............................................................................................. 37 Validation 編號 : No. OQ542JK1 HVAC 系統(tǒng) 運(yùn)行確認(rèn) OQ of HVAC 頁碼 : Page 5 of 37 QENNRAL RULE 目的 Purpose