【正文】 analytical work. Validation Committee Director: Approved the validation protocol and the validation report. 設備 工程 科 ：負責設備驗 證方案的起草及 驗證工作的具體實施 ，起草驗證報告。 生產部： 復核驗證方案，協助設備工程科進行驗證工作的實施 。 質量部： 負 責 驗證文件的審核 ， 負責 相關檢驗任務 。 驗證委員會主任：負責設備及公用工程系統驗證方案及報告的批準。 Validation process should be strictly in accordance with the approved validation protocol, if need to change for special reasons, they should fill out the the validation protocol change application and approval forms (attachment 1), according to the original Purified Water System Validation Protocol 純化水系統驗證方案 Document Revision 00 Date 日期 20200301 Company Name 公司名稱 Page 頁碼 Page 5 of 39 review and approval procedures for the approval before the Executive the change. 驗證過程應嚴格按照本方案規(guī)定的內容進行，若因特殊原因確需變更時，應填寫《驗證方案變更申請及批準書》 (附件 1)， 按原審批程序 批準 后執(zhí)行。 4 Content, Method and Criterion/驗證內容、方法及合格標準 Qualification/預確認（安裝前確認） Document Qualification/資料確認 Confirmed that the relevant document to support the verification is plete, fill out confirm records in attachment 3./確認支持本驗證的相關資 料是否齊全 ，確認記錄填寫于附件 3 Document name/資料名稱 Confirm method/確認方法 Purified water system, the detailed design requirements and technical parameters of major equipment 純化水系統詳細設計要求及主要設備技術參數 Consult equipment archives 查閱 技術檔案 Ordering the contract, specifications and related technical information 純化水系統主要組成設備訂貨合同、說明書及相關技術資料 Consult equipment archives 查閱技術檔案 Mainly equipments Certificates 各設備檢驗合格證 Consult equipment archives 查閱技術檔案 Purified water quality standards 純化水質量標準 Consult CP2020 查閱技術檔案 查閱 藥典 2020 版純化水標準 Purified Water System Flow Chart 純化水系統工藝流程圖 Consult equipment archives and attached attachment 4. 查閱技術檔案 查閱并附于附件 4 Purified water system operation and maintenance standard operation procedures 純化水 系統操作 和維護保養(yǎng)標準操作 規(guī)程 Consult the relative SOP 查閱 技術檔案 Purified water system sample standard operating procedures 純化水 取樣標準操作規(guī)程 Consult the relative SOP 查閱技術檔案 Purified water system cleaning standard operating procedures 純化水 系統清潔 標準操作 規(guī)程 Consult the relative SOP 查閱技術檔案 Out of the box inspection records 開箱驗收記錄 Consult equipment archives 查閱技術檔案 Installation and missioning records 安裝調試記錄 Consult equipment archives 查閱技術檔案 Test Run Record 試運行記錄 Consult equipment archives 查閱技術檔案 Pipeline Pressure Test Record 管道試壓記錄 Consult equipment archives and attached attachment 5. 查閱并附于附件 5 Purified Water System Validation Protocol 純化水系統驗證方案 Document Revision 00 Date 日期 20200301 Company Name 公司名稱 Page 頁碼 Page 6 of 39 Pipe cleaning records before use 管道使用前清洗記錄 Consult equipment archives and attached attachment 6. 查閱并附于附件 6 Pipeline passivation Records 管道 鈍 化記錄 Consult equipment archives and attached attachment 7. 查閱并附于附件 7 Pipe disinfection record before use 管道使用前消毒記錄 Consult equipment archives and attached attachment 8. 查閱并附于附件 8 Water purification water system work diagram 純化水系統用水網絡圖 Consult equipment archives and attached attachment 9. 查閱附于附件 9 Qualification proof of the equipment supplier 各設備生產企業(yè)資質證明材料 Consult equipment archives and attached attachment 10. 查閱附于附件 10 The equipment inspection reports 各設備檢驗報告 Consult equipment archives and attached attachment 11. 查閱附于附件 11 Instrument calibration verification/儀器、儀表的檢定或 校驗 確認 Instruments used in System such as Pressure gauges, conductivity meter, etc. shall be calibrated, and within the validity period. The confirm records be filled in attachment 12. Instruments as follow must be calibrated. 系統所用的壓力表等及檢測所用的電導率儀等須經檢定或檢驗合格，并在檢定有效期內，確認記錄填寫于附件 12。 下列儀器儀表必須經過校驗。 Instrument Name/名 稱 Specification/型 號 （規(guī)格） Count/數 量 Pressure gauges/耐振 壓力表 4 Pressure gauges/耐振壓力表 01MPa 7 conductivity meter/電導率儀 / 1 PH meter /PH 計 / 1 After service Qualification/售后服務確認 Check the purified water system supplier after service information and assure it is plete. The information include supplier name, address, phone, should filled in the attachment 13. 檢查各主要設備售后服務資料是否齊全。包括單位名稱、地址、聯系電話、保修及維修等詳細資料，確認記錄填寫于附件 13。 Purified Water System Validation Protocol 純化水系統驗證方案 Document Revision 00 Date 日期 20200301 Company Name 公司名稱 Page 頁碼 Page 7 of 39 Installation qualification/安裝確認 Public Media Connect, confirmation records fill in attachment 14. 公用介質連接確認，確認記錄填寫于附件 14。 Power Supply Installation confirmation/電源安裝確認 Item/項目 Standard/合格標準 Method/確認方法 electric voltage/電壓 380V177。 20 V Multimeter test/萬用表檢測 the line of electricity demand/進線要求 Threephase fivewire/三相五線 Onsite inspection/現場檢查 YJV4 +BVR1 Onsite inspection/現場檢查 Ground Protection/接地保護 Grounding resistance is less than 4Ω /接地電阻小于 4Ω Ohmmeter measurements/歐姆表測量 Water supply installation confirmation/進水安裝確認 Item/項目 Standard/合格標準 Method/確認方法 Water quality requirements/水質要求 Should meet drinking water health standards (GB 57492020)/應符合生活飲用水衛(wèi)生標準（ GB 57492020） See Water Quality Test Report/見水質檢測報告 Pressure/壓力 Measured with pressure gauge/壓力表測量 Pipe diameter/管道管徑 DN32 Measured with vernier caliper/游標卡尺測量 Pipe material/管道材質 PP Inspection by Visual/目測 Purified water pipeline and Valves installation confirmation, the records fill in attachment 15./純化水管道及閥門 (3 路 )安裝確認，確認記錄填寫于附件 15. Item/項目 Standard/合格標準 Method/確認方法 Work press/操作壓力 Measured with pressure gauge/壓力表測量 Pipe diameter/管道管徑 DN32 2 Measured with vernier caliper/游標卡尺測量 Purified Water System Validation Protocol 純化水系統驗證方案 Document Revision 00 Date 日期 20200301 Company Name 公司名稱 Page 頁碼 Page 8 of 39 Pipe material/管道材質 SS304 Consult pipe material certificate document and attach it in attachment16./檢查材質證明并附于附件 16 Valves material/閥門材質 SS304 C