1、EXECUTION APPROVAL SIGNATURES 批準執行簽名The signatures below indicate approval of this protocol and its attachments and indicate that it is ready forexecution. Any changes or modifications to the intent or the acceptance criteria of this protocol followingapproval requires the generation of an amendment

2、 which must be approved prior to execution.下面的簽名表示批準本文件及其附件，且表明已經為執行作好了準備。在批準后，對本文件的目的或驗收標準進行的任何改變或修正都必須起改善的作用，在執行以前就必須取得批準。 Department amp Site Signature amp Date 單位部門 簽名與日期 Issued by 起草 Reviewed by 審核 Authorized by 批準 Contents 目錄1.0 SCOPE 范圍 . 42.0 PURPOSE 目的. 43.0 BACKGROUND- 背景. 44.0 INTRODUCTIO

3、N 介紹 . 45.0 REFERENCES 參考書目. 56.0 RESPONSIBLE PARTIES AND RESPONSIBILITIES 責任方及其責任. 67.0 SYSTEM DESCRIPTION 系統說明 . 7 GENERAL DESCRIPTION 總說明 . 7 PRETREATMENT UNIT 預處理單元 . 7 REVERSE OSMOSIS RO SYSTEM 反滲透 RO 系統 . 8 MIXED BED SYSTEM 混床系統. 9 MONITOR AND CONTROL SYSTEM 監視和控制系統 . 108.0 TESTING PROCEDURES

4、檢驗程序 . 109.0 ACCEPTANCE CRITERIA 驗收標準. 12 ATTACHMENT 1 - VALIDATION TEST EQUIPMENT AND MATERIALS 附件 1驗證測試設備和材料 . 13 ATTACHMENT 2 - SPECIFICATION AND PURCHASE ORDER VERIFICATION 附件 2 規范和采購單確認. 14 ATTACHMENT 3 - ENGINEERING DRAWING LIST 附件工程圖紙清單. 14 ATTACHMENT 4 - STANDARD OPERATING PROCEDURES LIST 附件

5、 4標準操作程序清單. 16 ATTACHMENT 5 - OPERATION AND MAINTENANCE MANUAL LIST 附件 5操作和維護手冊清單 . 17 ATTACHMENT 6 - MAJOR COMPONENT LABELING LIST 附件 6 主要部件標簽清單 . 18 ATTACHMENT 7 - CRITICAL INSTRUMENT LIST 附件 7 關鍵儀器清單 . 18 ATTACHMENT 8 - NON-CRITICAL INSTRUMENT LIST 附件 8非關鍵儀器清單 . 19 ATTACHMENT 9 - SPARE PARTS LIST

6、 附件 9備件清單 . 20 ATTACHMENT 10 - INSTALLATION PROCEDURES VERIFICATION DATA SHEET 附件 10安裝程序確認數據表 . 21 ATTACHMENT 11 - UTILITY DATA SHEET: ELECTRICAL 附件 11公用工程數據表：電 . 23 ATTACHMENT 12 - UTILITY DATA SHEET: COMPRESSED AIR 附件 12公用工程數據表：壓縮空氣 . 23 ATTACHMENT 13 - UTILITY DATA SHEET: CITY WATER 附件 13公用工程數據表：

7、自來水 . 24 ATTACHMENT 14 - UTILITY DATA SHEET: WASTE/DRAIN 附件 14公用工程數據表：廢水/排水. 25 ATTACHMENT 15 - PW DISTRIBUTION LOOP DATA SHEET 附件 15純化水循環回路數據表 . 27 ATTACHMENT 16 CHEMICAL TANK AND DOSING PUMP DATA SHEET 附件 16化學罐和計量泵數據表 . 28 ATTACHMENT 17 SAND FILTER DATA SHEET 附件 17砂濾過濾器表 . 29 ATTACHMENT 18 - HEAT

8、EXCHANGER DATA SHEET PRETREATMENT 附件 18熱交換器數據表（預處理） . 30 ATTACHMENT 19 - ACTIVATED CARBON FILTER DATA SHEET 附件 19活性炭過濾器數據表. 31 ATTACHMENT 20 STERILIZATION PUMP DATA SHEET 附件 20滅菌循環泵數據表. 32 ATTACHMENT 21 - SOFTENER DATA SHEET 附件 21軟化器數據表 . 33 ATTACHMENT 22 - PRECISION FILTER DATA SHEET 附件 22精密過濾器數據表

9、. 34 ATTACHMENT 23 BOOSTER PUMPS DATA SHEET 附件 23增壓泵數據表. 34 ATTACHMENT 24 RO CLEANING TANK AND PUMP DATA SHEET 附件 24 RO 藥洗箱和泵數據表. 36 ATTACHMENT 25 - REVERSE OSMOSIS RO SYSTEM DATA SHEET 附件 25 -反滲透 RO 系統數據表. 37 ATTACHMENT 26 - INTERMEDIATE STORAGE TANK DATA SHEET 附件 26 - 中間儲罐數據表. 38 ATTACHMENT 27 - M

10、IXED BED SYSTEM DATA SHEET 附件 27 -混床系統數據表. 39 ATTACHMENT 28 MIXED BED REGENERATION TANKS AND PUMPS DATA SHEET 附件 28 混床再生酸堿箱和泵數據 表 . 40 ATTACHMENT 29 - MICRO FILTER DATA SHEET 附件 29微濾器數據表. 41ATTACHMENT 30 -4T DEIONIZED WATER STORAGE TANK DATA SHEET 附件 30 4 噸去離子水儲罐數據表. 42ATTACHMENT 31 -1T PW STORAGE T

11、ANK DATA SHEET 附件 31 1 噸純水儲罐數據表 . 43ATTACHMENT 32- STORAGE TANK SPRAY BALL DATA SHEET 附件 32 儲罐噴淋球數據表 . 44ATTACHMENT 33 - UV SANITIZER UNIT DATA SHEET 附件 33 - UV 滅菌器數據表. 45ATTACHMENT 34 RESIN TANK DATA SHEET 附件 34核子級樹脂罐表. 46ATTACHMENT 35 -2T PW STORAGE TANK DATA SHEET 附件 35 2 噸純水儲罐數據表 . 47ATTACHMENT

12、36 -300L PW STORAGE TANK DATA SHEET 附件 36 300L 純水儲罐數據表. 48ATTACHMENT 37 -HEAT EXCHANGER LOOP BUFFER TANK DATA SHEET 附件 37 熱交換器循環緩沖罐數據表 . 49ATTACHMENT 38 - VALVE DATA SHEET 附件 38 - 閥門數據表 . 50ATTACHMENT 39 - SAMPLE PORTS DATA SHEETS 附件 39 - 取樣口數據表 . 51ATTACHMENT 40 - SIGNATURE VERIFICATION LIST 附件 40

13、- 簽名確認清單 . 52ATTACHMENT 41 - PROTOCOL DEVIATION LOG 附件 41 - 文件偏差日志 . 52ATTACHMENT 42 - PROTOCOL DEVIATION RECORD 附件 42 - 文件偏差記錄. 54ATTACHMENT 43 - PROTOCOL EXECUTION APPROVAL SIGNATURES DATA SHEET 附件 43 -文件執行批準簽名數據表 . 551.0 SCOPE 范圍 This Installation Qualification IQ study will be performed on the P

14、urified Water PW System located in YUNG SHIN PHARM.IND.KSCO.LTD. 本次安裝鑒定 IQ將會在位于永信藥品工業（昆山）有限公司的純化水（PW）系統上實施。 This protocol describes the equipment test procedures specifications documents and references used to establish that the manufacturing facility Purified Water PW System has been installed and

15、operates in accordance with the manufacturers design specifications and those of YUNG SHIN PHARM.IND.KSCO.LTD. Company LTD. The facility shall be referred to as YUNG SHIN PHARM.IND.KSCO.LTD. throughout the remainder of this document. The unit will be referred to as the “PW system” throughout this do

16、cument. 本文件內容涉及設備、測試步驟、規格、文檔和參考書目，這些是用來確保純化水PW系統已經按生 產商設計規范和永信藥品工業（昆山）有限公司要求安裝和操作。本文件下文中工廠指的是永信藥品 工業（昆山）有限公司，單元指的是“純化水系統”。 This documentation package has been prepared by Shanghai Baoju personnel. This document will provide for the delineation of responsibilities of Shanghai Baoju and YUNG SHIN PHAR

17、M.IND.KSCO.LTD. appropriate approval signatures support documentation and other factors that are normally included in a protocol package. All supporting data and documentation will be attached to this validation protocol when completed. 本文件包由納盛機電準備。本文件將定義納盛機電和永信藥品工業（昆山）有限公司的責任、相關的 批準簽名、支持文件和其他一般文件包中

18、都有的因素。完成本驗證文件后附上所有的支持數據和文 件。2.0 PURPOSE 目的 The execution of this protocol will demonstrate and document that the PW system has been installed and operates according to the manufacturers specifications and YUNG SHIN PHARM.IND.KSCO.LTD. requirements. 本文件的執行將記錄和證明純化水系統已經按生產商規范和永信藥品工業（昆山）有限公司要求安裝 和操作。3.

19、0 BACKGROUND- 背景 The manufacturing facility PW system is designed to provide PW grade water for manufacturing use in YUNG SHIN PHARM.IND.KSCO.LTD. This water will be for general manufacturing and formulation use. 生產設備純化水系統為永信藥品工業（昆山）有限公司提供純化水級別的生產用水。這些水將用于一 般生產和配制使用。4.0 INTRODUCTION 介紹 This Installa

20、tion Qualification IQ protocol is specific for the manufacturing facility PW system located in YUNG SHIN PHARM.IND.KSCO.LTD. 本安裝確認文件（IQ）文件專用于位于永信藥品工業（昆山）有限公司的生產用純化水系統。 Installation checks will be performed to verify and document that the equipment is installed with the proper supporting utilities se

21、rvices and components. All instrument calibration standardization or adjustment will be performed and documented for the measuring equipment used during the execution of this protocol. Standards used will be traceable to the National Institute of Standards and Technology NIST. Other accepted standar

22、ds will be used where applicable if NIST standards do not exist. 進行安裝檢查，以確認和記錄設備已經與相關的公用工程、服務和部件連接。在文件執行過程中，作 為測量工具，所有的儀器校驗、標準化或調整都將進行，且記錄下來。所使用的標準都可追溯到美國 國家標準和技術研究院NIST。如果 NIST 不涉及的地方也可使用其他的驗收標準。 Documentation associated with the system such as operators or owners manuals system drawings purchase s

23、pecifications cut sheets component specification sheets materials listings installation diagrams component plans and other data etc. will be reviewed in this report. Copies of these will be included in this report or the storage location of the documentation will be recorded. 在本報告中審核與系統有關的文件，如操作者或所有

24、者手冊、系統圖紙、采購要求、部件規范表、材 料清單、安裝圖紙、平面布局圖和其他的數據，等等。該報告包括有他們的復印件，或記錄了文檔儲 存地點。 Any deviations from the protocol or from specifications or any exceptional conditions encountered will be documented and identified for review on the Protocol Deviation Report Form. The deviations and exceptional conditions note

25、d will be investigated and appropriate actions determined and implemented. The investigations along with the corrective actions and their justifications will be documented on the Protocol Deviation Report Form. 任何與文件或規范的偏差或遇到任何例外的情況都要記錄下來，加以鑒別，以供文件偏差報告表的審 查。記錄的偏差和例外情況要進行調查，而且決定并采取相應的措施。文件偏差報告表中需記錄有調

26、 查、糾正性措施及其理由。 Final protocol package approval will be by the same personnel who initially approved the protocol by their designee or by another person holding an equivalent level of authority. 最終文件包的批準人必須是文件最初批準人、其指定人、或其他的有同等權力的人員。5.0 REFERENCES 參考書目 This protocol conforms to the applicable guidelin

27、es of the publications listed below. Each publication shall be the latest revision with all addenda in effect on the date of approval of the protocol unless otherwise noted. 該文件符合下列出版物中的規范。除非另外注明，否則每個出版物都指的是截止批準之日的最新的版 本，其附錄也有效。 21 CFR Part 211: Code of Federal Regulations Current Good Manufacturing

28、 Practice for Finished Pharmaceuticals 21 CFR 第 210 和 211 部分：聯邦條例法典，成品藥 cGMP USP 28 - United States Pharmacopeia USP 28 美國藥典 NIST - National Institute of Standards and Technology NIST 美國國家標準技術研究所 Draft SOP of the PW System 純化水系統的 SOP6.0 RESPONSIBLE PARTIES AND RESPONSIBILITIES 責任方及其責任 Shanghai Baoju Fluid Equipment Engineering Co. Ltd. 納盛機電流體設備工程有限公司：. Writing of this protocol. 編寫本文件 Review and approval of the original protocol. 審核和批準原始文件 Review and approval of the completed protocol package 審核和批準完成的文件包 Engineering / Maintenance Responsibilities: 工程/維護責任：