冷庫(kù)設(shè)計(jì)確認(rèn)

1、LOGODeSign QUalifiCatiOn PrOtOCOl and RePOrt 設(shè)計(jì)確認(rèn)方案和報(bào)告項(xiàng)目名稱(chēng)文件編號(hào)冷庫(kù)COld StOrage ROOmRqv.版本：OOlDeSign QUalifiCatiOn PrOtOCOl Of COId StOrage ROOmS冷庫(kù)設(shè)計(jì)確認(rèn)方案PreParatiOn 編制Name: 姓名Date: 日期Signature: 簽名ReVieW審核Name:Date:Signature:姓需日期簽名Name:Date:Signature:姓需日期簽名APPrOVal 批準(zhǔn)Name:Date:Signature:姓名日期簽名Name:Date:

2、Signature:姓需日期簽名Name:Date:Signature:姓需日期簽名Name:Date:Sisnature:姓需日期簽名Page 8 of 17Table Of COntent目錄LOGODeSign QUaIifiCatiOn PrOtOCOl and RePOrt 設(shè)計(jì)確認(rèn)方案和報(bào)告項(xiàng)目名稱(chēng)文件編號(hào)冷庫(kù)COld StOrage ROOmRz版本：OOl目錄1 INTRODUCTION 概述32 RESPONSIBILITY 職責(zé)33 SYSTEMQUIPMENT DESCRlPTION系細(xì)設(shè)備描述34 PROCEDURE 程序44PrereqUiSiteS for DQDQ

3、HU44.2 Table Of ReqUirementS需求表44.3 DQ設(shè)計(jì)確認(rèn)44.4 RePOrt 報(bào)告45 ABBREVIATIONS AND DEFINITIONS縮寫(xiě)和走義56 ReferenCe DOClllnentS 參考文件57 Change LOg 修訂日志APPendiX A PartiCiPant LiSt 附錄A 參會(huì)人員7APPendiX B DeSiglI documentation and URS VerifiCatiOn 附錄B 設(shè)計(jì)文件和用戶(hù)需求確認(rèn)8APPendiX C TabIe Of ReqUirenIent 附錄C 用戶(hù)需求確認(rèn)9APPendiX

4、D DeViatiOn LiSt 附錄 D 偏差歹U表15APPendiX E DeViatiOn RQpOlt附錄 E 偏差報(bào)告16LOGODeSign QUaIifiCatiOn PrOtOCOl and RePOrt 設(shè)計(jì)確認(rèn)方案和報(bào)告項(xiàng)目名稱(chēng)文件編號(hào)冷庫(kù)COld StOrage ROOmRz版本：OOl1 INTRODUCTION M½Tlle PUrPOSe Of the PrOtOCOvrq)Ort to describe ad document tle design qualification.本方案報(bào)告的目的是描述和記錄設(shè)計(jì)確認(rèn)。The PUiPOSe Of desi

5、gn qualification is to assess Wllether die PrOPOSed design Of die HtyZequipment is expected to be "fit for the intended use" Of the facltyequmet and meet IISer and COmPllalICe requirements".設(shè)訃確認(rèn)的目的是評(píng)估提出的設(shè)施/設(shè)備的設(shè)訃是否如預(yù)期滿(mǎn)足設(shè)施/設(shè)備的使用和符合性要求。2 RESPONSIBILITY 職責(zé)It is die IeSPOnSIbility Of engne

6、ermgrocess department to assure PrOCeSS requirements, equipment facilities ad OPeratIon IeqUIrementS are addressed In design documents.工程工藝部門(mén)的責(zé)任是確保工藝要求、設(shè)備設(shè)施和操作要求在設(shè)計(jì)文件中得到滿(mǎn)足。Tlle eiigmeering IeSPOnSlble approve this document On GMP compliance.質(zhì)量保證部負(fù)責(zé)審査本文件是否符合GMP要求。The quality Inanager is IeSPOIlSlble

7、for approving this document to meet the IeqUlrementS Of the quality management SyStem ad GMP質(zhì)量保證部負(fù)責(zé)批準(zhǔn)本文件符合質(zhì)量管理體系和GMP的要求。3 SYSTENrJEQUIPMENT DESCRIPTION 系統(tǒng)設(shè)備描述There are tlree COld StOrage IOOnIS m the first floor The COld StOrage IOOmS are USed to keep the 2-8 C environment to keep the materials and

8、PrOdUCtS that are temperanre SenSitiV巴一層3個(gè)拼裝式冷藏庫(kù)。冷藏室保持2-8攝氏度的環(huán)境，以保護(hù)對(duì)溫度敏感的材料和產(chǎn)品。TheIgeration SyStem Of the COld StOrage COnSIStS Of a direct expansion mdoor fan COlI ut, a COmPreSSOrIOCated On the OUtdOOr IOOf and a COndenSer IOCated on the ceiling.冷庫(kù)的制冷系統(tǒng)由直接膨脹式的室內(nèi)風(fēng)機(jī)盤(pán)管單元，一個(gè)位于室外屋面的圧縮機(jī)和一個(gè)位于吊頂 的冷凝器組成。TW

9、O COOlUlg SyStem (One is Stalldby) Shall be COnSidered for each COld room.每一個(gè)冷庫(kù)應(yīng)考慮兩套制冷系統(tǒng)(一用一備)。4 PROCEDURE41 PrereqUiSiteS for DQ DQ 前提USer requirement SPeCifICatIOn and design SPeCifiCatIOnS are approved.LOGODeSign QUaIifiCatiOn PrOtOCOl and RePOrt 設(shè)計(jì)確認(rèn)方案和報(bào)告項(xiàng)目名稱(chēng)文件編號(hào)冷庫(kù)COld StOrage ROOmRz版本：OOl用戶(hù)需求和設(shè)

10、計(jì)已批準(zhǔn)。4.2 TabIe Of ReqUirementS 需求表 PlePaTatlolI Of table Of requirements. FiIl in table Of requirements With IeqUIrementS from TS 準(zhǔn)備需求表。在需求表中填入用戶(hù)需求要求 EnClOSe table Of IeqUIreIllentS for PrOtOCOl as APPendlX B將需求表作為本方案的附錄B4.3 DQ設(shè)計(jì)確認(rèn) DQ PrOtOCOl is approved.設(shè)計(jì)確認(rèn)方案批準(zhǔn)。 PrOdUCtion responsible PerSon CaIl

11、S in a design qualification meeting benveen PrOdUCtIOIl IeSPOnSible person. QA and SyStem IeSPOnSible (if relevant). ReView the SeIeCted IeqUIrementS and design documents to make SUre that the IeqUirementS are IefleCted m the design documentation. AlI PerSonllel InVOlVed need Sigll in PartICiPant li

12、st, APPendIX A生產(chǎn)負(fù)責(zé)人召集生產(chǎn)負(fù)責(zé)人、QA和系統(tǒng)負(fù)責(zé)人參加的設(shè)計(jì)確認(rèn)會(huì)議。審核需求和設(shè)計(jì)文件確 保設(shè)計(jì)文件中反映了需求。所有相關(guān)人員需在參加者名單(附錄A)上簽字 Verify the approved URS and design documents relevant. RegiSter tle VeISionS in APPendIX B 驗(yàn)證批準(zhǔn)的URS和相關(guān)設(shè)計(jì)文件。在附錄B中登記版本 APPIy actions if the IeqUIremelltS are not InIPlemented in the design. ACtionS to be applied

13、are documented In DeViatiOn LISt (APPeildIX C)如果需求在設(shè)汁中未實(shí)施，應(yīng)采取措施。采取的措施記錄在偏差淸單里(附錄C) All the VenfkatIOll Can be Perfbmled In e-fbrm and then Prmted out, SIgXl and date by the executor. 所有驗(yàn)證都可以通過(guò)電子表格進(jìn)行，然后由執(zhí)行人打印、簽名和日期4.4 RePOrt 報(bào)告APPly the OVelaII ConChISIOn On the design qualification In the COnClUSiOn

14、 box When actions are fllfilled. 措施完成時(shí)，在結(jié)論欄寫(xiě)入設(shè)計(jì)確認(rèn)的總結(jié)論。Tlle PrOtOCOl section, the COmPleted table Of IeqUIrementS and ACtIon List, ad the COnClUSion COnStiUlte the report.設(shè)計(jì)確認(rèn)的方案、完成的需求表和措施淸單及結(jié)論組成報(bào)告。Approve the IePort When the IeqUIred actoas are fulfilled and the COnCkISIOn is PrePared-當(dāng)必需的措施完成且完成結(jié)論部

15、分，批準(zhǔn)報(bào)告。LOGODeSign QUaIifiCatiOn PrOtOCOl and RePOrt 設(shè)計(jì)確認(rèn)方案和報(bào)告項(xiàng)目名稱(chēng)文件編號(hào)冷庫(kù)COld StOrage ROOmRz版本：OOl5 ABBREy7IATIONSAND DEFINlTlONS 縮寫(xiě)和定義AbbreViatiOnS 縮略語(yǔ)Deflnition 定義GMPGOOd ManUfaCtUring PraCtiCe 藥品生產(chǎn)質(zhì)量管理規(guī)范DQDCSign QUaIifiCatiOn 設(shè)計(jì)確認(rèn)IQInStalIatiOn QUaIifiCatiOn 安裝確認(rèn)OQOPeratiOnal QUalifiCatiOn 運(yùn)行確認(rèn)SATS

16、ite ACCePtanCe TeSt 現(xiàn)場(chǎng)驗(yàn)收測(cè)試6 ReferenCe DOCUmentS 參考文件X'Good ManUfaCnIrmg PraCtiCe for PharmaCeUtiCal PrOdUCtS5' (2010 VerSiOn)藥品生產(chǎn)質(zhì)量管理規(guī)范(2010年修訂版)。> COId StOrage design COde (GB5OO72-2010)冷庫(kù)設(shè)訃規(guī)范(GB500722010)> COde for COnStrUCtiOn and acceptance Of field equipment, industrial PiPe Weldi

17、ng engineering (GB50236-201)現(xiàn)場(chǎng)設(shè)備、工業(yè)管道焊接工程及驗(yàn)收規(guī)范(GB50236-2011)> COde for COnStrUCtiOn and acceptance Of refrigeration and air SeParating equipment installation engineering (GB50274-2010)制冷設(shè)備、空氣分離設(shè)備安裝工程施工及驗(yàn)收規(guī)范(GB50274-2010)> RClatiVe StandardS Of EMEA and FDA CGMP歐盟和美國(guó)相關(guān)CGMP標(biāo)準(zhǔn)> RelatiVe Standa

18、rd OfIEC (InternatiOnal EleCtrO-technical COnImiSSiOn)IEC (國(guó)際電工委員會(huì))相關(guān)標(biāo)準(zhǔn)> Other relative Standardregulationcode Of local/national.地方及國(guó)家相應(yīng)的的苴它規(guī)范、規(guī)泄及標(biāo)準(zhǔn)LOGODeSign QUaIifiCatiOn PrOtOCOl and RePOrt 設(shè)計(jì)確認(rèn)方案和報(bào)告項(xiàng)目名稱(chēng)文件編號(hào)冷庫(kù)COld StOrage ROOmRz版本：OOl7 Change Log修訂日志Date 時(shí)間Name 姓名ReViSiOn 修訂SeCtiOn章節(jié)Change/Com

19、ments 更改描述OOlNeW DOCUmCnt 新文件LOGODeSign QUalifiCatiOn PrOtOCOl and RePOrt 設(shè)計(jì)確認(rèn)方案和報(bào)告項(xiàng)目名稱(chēng)文件編號(hào)冷庫(kù)COld StOrage ROOmRqv.版本：OOlAPPendiX A Pailicipant LiSt 附錄A 參會(huì)人員Name 姓名TltIe職位SignatureXDate 簽名日期LOGODeSign QUalifiCatiOn PrOtOCOl and RePOrt 設(shè)計(jì)確認(rèn)方案和報(bào)告項(xiàng)目名稱(chēng)文件編號(hào)冷庫(kù)COld StOrage ROOmRqv.版本：OOlAPPendiX B DeSign do

20、cumentation and URS VerifiCatiOn 附錄B 設(shè)計(jì)文件和 用戶(hù)需求確認(rèn)No. 序號(hào)DoCUment/Drawing TitIe 文件/圖紙名稱(chēng)Doc/drawing No. 文件/圖紙編號(hào)VerSiOn 當(dāng)前版本Ol0203040506070809101112131415DeSign QUaIifiCatiOn PrOtOCOl and RePOrt 設(shè)計(jì)確認(rèn)方案和報(bào)告冷庫(kù)COld StOrage ROOmRh版本：OOlAPPendiX C TabIe OfReqUiIement 附錄C 用戶(hù)需求確認(rèn)URS ID用戶(hù)要求編號(hào)ReqUirement URS要求DeS

21、ign Doc. Name SeCtiOn if relevant 設(shè)計(jì)文件名稱(chēng)相關(guān)章節(jié)OK/ not OKACtiOIl No. 措施編號(hào)General FUnCtiOn RCqUirement 通用功能要求4.1.1The COld StOrage InUSt be CqUiPPed With two independent refrigeration systems. ThC temperature in COld StOrage is evenly and Stable WhCn One refrigeration SyStem is down.冷庫(kù)必須配備兩套獨(dú)立的制冷系統(tǒng)。在一套制

22、冷系統(tǒng)停機(jī)時(shí)可以保持庫(kù)溫 均勻穩(wěn)定。General FUnCtiOn RCqUireInent 通用功能要求4.1.2ThC tag number is to be applied to CritiCal COmPOnentS and to all cables. 關(guān)鍵組件和線纜需標(biāo)有位號(hào)。4.1.3DeSign document 設(shè)計(jì)文件DraWing(S) ShOWing room lay-out. incl. COOling units, Panet racks SenSOr IOCatiOn(s), COOIine Unit COntrOller(S)房間布局的圖紙，包括冷機(jī)設(shè)備、托盤(pán)

23、、傳感器位置、冷機(jī)設(shè)備控制器。DeSign QUaIifiCatiOn PrOtOCOl and RePOrt 設(shè)計(jì)確認(rèn)方案和報(bào)告冷庫(kù)COld StOrage ROOmRz：版本：OOlURS ID 用戶(hù)要求編號(hào)ReqUirenlentURS要求DeSign Doc. Name SeCtiOn if relevant 設(shè)計(jì)文件名稱(chēng)相關(guān)章節(jié)OK/ not OKACtiOII No. 措施編號(hào)LiSt COntaininS InanUfaCtUrer and model Of main COmPOnentS 包含制造商和主要組件型號(hào)的淸單4.1.4Operating/ maintenance In

24、anUal(S) for: 操作/維護(hù)手冊(cè)：COOIing Unit COntrOller冷機(jī)控制器COnIPreSSOr Unit壓縮機(jī)COOIing Unit冷機(jī)InStrUCtiOn for maintenance Of Inain cling SyStem components:主要冷卻系統(tǒng)組件維護(hù)指南：COmPreSSOr Unit壓縮機(jī)COOling Unit冷機(jī)4.1.5ThC Iighting in the rn is 200 Lux. 房間內(nèi)的照明強(qiáng)度為200 Lux0DeSign QUaIifiCatiOn PrOtOCOl and RePOrt 設(shè)計(jì)確認(rèn)方案和報(bào)告冷庫(kù)CO

25、ld StOrage ROOmRz：版本：OOlURS ID 用戶(hù)要求編號(hào)ReqUirenlentURS要求DeSign Doc. Name SeCtiOn if relevant 設(shè)計(jì)文件名稱(chēng)相關(guān)章節(jié)OK/ not OKACtiOII No. 措施編號(hào)4.1.6NOtSe IeVel 80 dB(A) 噪聲不超過(guò)80分貝。4.1.7All inner SUrfaCeS ShOUId be SmOOth and CIeanable 所有內(nèi)表而必須光滑，易于淸潔。MeaSUrement ReqUirenlentS 測(cè)量要求4.2.1PriOr to OPerating the COld StOr

26、age room, the temperature COntrOning SenSOr ShOUId have the risht type, measure range. MPE and accuracy, also be Calibrated.在操作該冷庫(kù)前，溫度控制傳感器要有正確的選型、量程、MPE和精度， 且都要經(jīng)過(guò)校準(zhǔn)。AlanIK arming and message 報(bào)警、警告和信息431When the temperature is OUt Of range, an alan Shan be activated. 當(dāng)溫度超出范圍時(shí)，應(yīng)啟動(dòng)報(bào)警。COntrOl SyStem 控制

27、系統(tǒng)DeSign QUaIifiCatiOn PrOtOCOl and RePOrt 設(shè)計(jì)確認(rèn)方案和報(bào)告冷庫(kù)COld StOrage ROOmRz：版本：OOlURS ID 用戶(hù)要求編號(hào)ReqUirenlentURS要求DeSign Doc. Name SeCtiOn if relevant 設(shè)計(jì)文件名稱(chēng)相關(guān)章節(jié)OK/ not OKACtiOII No. 措施編號(hào)4.4.1Stand-alone PLC Of COld StOrage Shall PrOVide COmmUniCatiOn interface to BMS for SySteln nonitorins including St

28、atUS monitoring & fan fault alarm monitoring. 冷庫(kù)的就地控制器Dlc應(yīng)提供通訊接口給BMS用于對(duì)其監(jiān)視包括運(yùn)行狀態(tài) 和故障報(bào)警的監(jiān)視。FUnCtiOnal ReqUirement for ACCeSS AUthOrity 訪問(wèn)權(quán)限功能需求4.5.1OnIy authorized PerSOnnel is allowed access to Change the SettingS Of the PrOCeSS ParalneterS Of the COOlinS Imit COntrOIler.只有授權(quán)的人允許變更冷機(jī)控制器工藝參數(shù)的設(shè)置。4

29、.5.2The COld StOraSe Can Only be accessed by authorization. 進(jìn)入冷庫(kù)，必須要有授權(quán)。PerfOrmanCe ReqUirement 性能需求4.6.1TemPeratUre inside the COId StOrage InUSt ensure that the PrOdUCtS are kept at a temperature between 2-8 °C.ThC COld StOrage temperature between 2-8 OC InUSt be Inaintaincd:In all PartS Of C

30、Old StOrageAt all filling IeVeIS Of COld StOrageDeSign QUaIifiCatiOn PrOtOCOl and RePOrt 設(shè)計(jì)確認(rèn)方案和報(bào)告冷庫(kù)COld StOrage ROOmRz：版本：OOlURS ID 用戶(hù)要求編號(hào)ReqUirenlentURS要求DeSign Doc. Name SeCtiOn if relevant 設(shè)計(jì)文件名稱(chēng)相關(guān)章節(jié)OK/ not OKACtiOII No. 措施編號(hào)EVen in CaSe One COOIing SyStem is OUt Of SerViCe DUring empty IOad and

31、 full IOad for initial COld StOrage qualification.During full IOad for revalidation Of the COld StOrage冷庫(kù)室內(nèi)溫度必須保證產(chǎn)品是處于2-8。C的環(huán)境中，并且房間在下列情況下 都要保持在2-8攝氏度：房間內(nèi)各部分各裝載水平甚至當(dāng)任何一臺(tái)制冷系統(tǒng)岀故障的時(shí)候冷庫(kù)初次的空載和滿(mǎn)載期間的驗(yàn)證再驗(yàn)證的滿(mǎn)載期間4.6.2The air-stream from the COOling Unit(S) exit must not hit the PrOdUCtS directly On the horizo

32、n IeVeL冷風(fēng)機(jī)出口的冷風(fēng)不能直接(水平方向)吹在產(chǎn)品上。4.6.3PlaCeS Where PrOdUCt must not be StOred must be marked 不能存放產(chǎn)品的地方必須標(biāo)記。DeSign QUaIifiCatiOn PrOtOCOl and RePOrt 設(shè)計(jì)確認(rèn)方案和報(bào)告冷庫(kù)COld StOrage ROOmRz：版本：OOlURS ID 用戶(hù)要求編號(hào)ReqUirenlentURS要求DeSign Doc. Name SeCtiOn if relevant 設(shè)計(jì)文件名稱(chēng)相關(guān)章節(jié)OK/ not OKACtiOII No. 措施編號(hào)4.6.4There must be Pet COntrOI. 需有昆蟲(chóng)和動(dòng)物控制措施。Safety全4.7.1ACCeSS doors are Well designed SO that they Can always be OPened from the inside regardless Of the State Of door IOCkS and/or Card reader.不論門(mén)鎖和讀卡器處于何種狀態(tài)，所有的門(mén)都可以從內(nèi)部打開(kāi)。COnClUSion： 結(jié)論P(yáng)age 14 of 17LOGODeSign QUalifiCatiOn PrOtOCOl and RePOrt 設(shè)計(jì)確認(rèn)方案