冷库设计确认

1、LOGODeSign QUalifiCatiOn PrOtOCOl and RePOrt 设计确认方案和报告项目名称文件编号冷库COld StOrage ROOmRqv.版本：OOlDeSign QUalifiCatiOn PrOtOCOl Of COId StOrage ROOmS冷库设计确认方案PreParatiOn 编制Name: 姓名Date: 日期Signature: 签名ReVieW审核Name:Date:Signature:姓需日期签名Name:Date:Signature:姓需日期签名APPrOVal 批准Name:Date:Signature:姓名日期签名Name:Date:

2、Signature:姓需日期签名Name:Date:Signature:姓需日期签名Name:Date:Sisnature:姓需日期签名Page 8 of 17Table Of COntent目录LOGODeSign QUaIifiCatiOn PrOtOCOl and RePOrt 设计确认方案和报告项目名称文件编号冷库COld StOrage ROOmRz版本：OOl目录1 INTRODUCTION 概述32 RESPONSIBILITY 职责33 SYSTEMQUIPMENT DESCRlPTION系细设备描述34 PROCEDURE 程序44PrereqUiSiteS for DQDQ

3、HU44.2 Table Of ReqUirementS需求表44.3 DQ设计确认44.4 RePOrt 报告45 ABBREVIATIONS AND DEFINITIONS缩写和走义56 ReferenCe DOClllnentS 参考文件57 Change LOg 修订日志APPendiX A PartiCiPant LiSt 附录A 参会人员7APPendiX B DeSiglI documentation and URS VerifiCatiOn 附录B 设计文件和用户需求确认8APPendiX C TabIe Of ReqUirenIent 附录C 用户需求确认9APPendiX

4、D DeViatiOn LiSt 附录 D 偏差歹U表15APPendiX E DeViatiOn RQpOlt附录 E 偏差报告16LOGODeSign QUaIifiCatiOn PrOtOCOl and RePOrt 设计确认方案和报告项目名称文件编号冷库COld StOrage ROOmRz版本：OOl1 INTRODUCTION M½Tlle PUrPOSe Of the PrOtOCOvrq)Ort to describe ad document tle design qualification.本方案报告的目的是描述和记录设计确认。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".设讣确认的目的是评估提出的设施/设备的设讣是否如预期满足设施/设备的使用和符合性要求。2 RESPONSIBILITY 职责It is die IeSPOnSIbility Of engne

6、ermgrocess department to assure PrOCeSS requirements, equipment facilities ad OPeratIon IeqUIrementS are addressed In design documents.工程工艺部门的责任是确保工艺要求、设备设施和操作要求在设计文件中得到满足。Tlle eiigmeering IeSPOnSlble approve this document On GMP compliance.质量保证部负责审査本文件是否符合GMP要求。The quality Inanager is IeSPOIlSlble

7、for approving this document to meet the IeqUlrementS Of the quality management SyStem ad GMP质量保证部负责批准本文件符合质量管理体系和GMP的要求。3 SYSTENrJEQUIPMENT DESCRIPTION 系统设备描述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巴一层3个拼装式冷藏库。冷藏室保持2-8摄氏度的环境，以保护对温度敏感的材料和产品。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.冷库的制冷系统由直接膨胀式的室内风机盘管单元，一个位于室外屋面的圧缩机和一个位于吊顶 的冷凝器组成。TW

9、O COOlUlg SyStem (One is Stalldby) Shall be COnSidered for each COld room.每一个冷库应考虑两套制冷系统(一用一备)。4 PROCEDURE41 PrereqUiSiteS for DQ DQ 前提USer requirement SPeCifICatIOn and design SPeCifiCatIOnS are approved.LOGODeSign QUaIifiCatiOn PrOtOCOl and RePOrt 设计确认方案和报告项目名称文件编号冷库COld StOrage ROOmRz版本：OOl用户需求和设

10、计已批准。4.2 TabIe Of ReqUirementS 需求表 PlePaTatlolI Of table Of requirements. FiIl in table Of requirements With IeqUIrementS from TS 准备需求表。在需求表中填入用户需求要求 EnClOSe table Of IeqUIreIllentS for PrOtOCOl as APPendlX B将需求表作为本方案的附录B4.3 DQ设计确认 DQ PrOtOCOl is approved.设计确认方案批准。 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生产负责人召集生产负责人、QA和系统负责人参加的设计确认会议。审核需求和设计文件确 保设计文件中反映了需求。所有相关人员需在参加者名单(附录A)上签字 Verify the approved URS and design documents relevant. RegiSter tle VeISionS in APPendIX B 验证批准的URS和相关设计文件。在附录B中登记版本 APPIy actions if the IeqUIremelltS are not InIPlemented in the design. ACtionS to be applied

13、are documented In DeViatiOn LISt (APPeildIX C)如果需求在设汁中未实施，应采取措施。采取的措施记录在偏差淸单里(附录C) All the VenfkatIOll Can be Perfbmled In e-fbrm and then Prmted out, SIgXl and date by the executor. 所有验证都可以通过电子表格进行，然后由执行人打印、签名和日期4.4 RePOrt 报告APPly the OVelaII ConChISIOn On the design qualification In the COnClUSiOn

14、 box When actions are fllfilled. 措施完成时，在结论栏写入设计确认的总结论。Tlle PrOtOCOl section, the COmPleted table Of IeqUIrementS and ACtIon List, ad the COnClUSion COnStiUlte the report.设计确认的方案、完成的需求表和措施淸单及结论组成报告。Approve the IePort When the IeqUIred actoas are fulfilled and the COnCkISIOn is PrePared-当必需的措施完成且完成结论部

15、分，批准报告。LOGODeSign QUaIifiCatiOn PrOtOCOl and RePOrt 设计确认方案和报告项目名称文件编号冷库COld StOrage ROOmRz版本：OOl5 ABBREy7IATIONSAND DEFINlTlONS 缩写和定义AbbreViatiOnS 缩略语Deflnition 定义GMPGOOd ManUfaCtUring PraCtiCe 药品生产质量管理规范DQDCSign QUaIifiCatiOn 设计确认IQInStalIatiOn QUaIifiCatiOn 安装确认OQOPeratiOnal QUalifiCatiOn 运行确认SATS

16、ite ACCePtanCe TeSt 现场验收测试6 ReferenCe DOCUmentS 参考文件X'Good ManUfaCnIrmg PraCtiCe for PharmaCeUtiCal PrOdUCtS5' (2010 VerSiOn)药品生产质量管理规范(2010年修订版)。> COId StOrage design COde (GB5OO72-2010)冷库设讣规范(GB500722010)> COde for COnStrUCtiOn and acceptance Of field equipment, industrial PiPe Weldi

17、ng engineering (GB50236-201)现场设备、工业管道焊接工程及验收规范(GB50236-2011)> COde for COnStrUCtiOn and acceptance Of refrigeration and air SeParating equipment installation engineering (GB50274-2010)制冷设备、空气分离设备安装工程施工及验收规范(GB50274-2010)> RClatiVe StandardS Of EMEA and FDA CGMP欧盟和美国相关CGMP标准> RelatiVe Standa

18、rd OfIEC (InternatiOnal EleCtrO-technical COnImiSSiOn)IEC (国际电工委员会)相关标准> Other relative Standardregulationcode Of local/national.地方及国家相应的的苴它规范、规泄及标准LOGODeSign QUaIifiCatiOn PrOtOCOl and RePOrt 设计确认方案和报告项目名称文件编号冷库COld StOrage ROOmRz版本：OOl7 Change Log修订日志Date 时间Name 姓名ReViSiOn 修订SeCtiOn章节Change/Com

19、ments 更改描述OOlNeW DOCUmCnt 新文件LOGODeSign QUalifiCatiOn PrOtOCOl and RePOrt 设计确认方案和报告项目名称文件编号冷库COld StOrage ROOmRqv.版本：OOlAPPendiX A Pailicipant LiSt 附录A 参会人员Name 姓名TltIe职位SignatureXDate 签名日期LOGODeSign QUalifiCatiOn PrOtOCOl and RePOrt 设计确认方案和报告项目名称文件编号冷库COld StOrage ROOmRqv.版本：OOlAPPendiX B DeSign do

20、cumentation and URS VerifiCatiOn 附录B 设计文件和 用户需求确认No. 序号DoCUment/Drawing TitIe 文件/图纸名称Doc/drawing No. 文件/图纸编号VerSiOn 当前版本Ol0203040506070809101112131415DeSign QUaIifiCatiOn PrOtOCOl and RePOrt 设计确认方案和报告冷库COld StOrage ROOmRh版本：OOlAPPendiX C TabIe OfReqUiIement 附录C 用户需求确认URS ID用户要求编号ReqUirement URS要求DeS

21、ign Doc. Name SeCtiOn if relevant 设计文件名称相关章节OK/ not OKACtiOIl No. 措施编号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.冷库必须配备两套独立的制冷系统。在一套制

22、冷系统停机时可以保持库温 均匀稳定。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. 关键组件和线缆需标有位号。4.1.3DeSign document 设计文件DraWing(S) ShOWing room lay-out. incl. COOling units, Panet racks SenSOr IOCatiOn(s), COOIine Unit COntrOller(S)房间布局的图纸，包括冷机设备、托盘

23、、传感器位置、冷机设备控制器。DeSign QUaIifiCatiOn PrOtOCOl and RePOrt 设计确认方案和报告冷库COld StOrage ROOmRz：版本：OOlURS ID 用户要求编号ReqUirenlentURS要求DeSign Doc. Name SeCtiOn if relevant 设计文件名称相关章节OK/ not OKACtiOII No. 措施编号LiSt COntaininS InanUfaCtUrer and model Of main COmPOnentS 包含制造商和主要组件型号的淸单4.1.4Operating/ maintenance In

24、anUal(S) for: 操作/维护手册：COOIing Unit COntrOller冷机控制器COnIPreSSOr Unit压缩机COOIing Unit冷机InStrUCtiOn for maintenance Of Inain cling SyStem components:主要冷却系统组件维护指南：COmPreSSOr Unit压缩机COOling Unit冷机4.1.5ThC Iighting in the rn is 200 Lux. 房间内的照明强度为200 Lux0DeSign QUaIifiCatiOn PrOtOCOl and RePOrt 设计确认方案和报告冷库CO

25、ld StOrage ROOmRz：版本：OOlURS ID 用户要求编号ReqUirenlentURS要求DeSign Doc. Name SeCtiOn if relevant 设计文件名称相关章节OK/ not OKACtiOII No. 措施编号4.1.6NOtSe IeVel 80 dB(A) 噪声不超过80分贝。4.1.7All inner SUrfaCeS ShOUId be SmOOth and CIeanable 所有内表而必须光滑，易于淸洁。MeaSUrement ReqUirenlentS 测量要求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.在操作该冷库前，温度控制传感器要有正确的选型、量程、MPE和精度， 且都要经过校准。AlanIK arming and message 报警、警告和信息431When the temperature is OUt Of range, an alan Shan be activated. 当温度超出范围时，应启动报警。COntrOl SyStem 控制

27、系统DeSign QUaIifiCatiOn PrOtOCOl and RePOrt 设计确认方案和报告冷库COld StOrage ROOmRz：版本：OOlURS ID 用户要求编号ReqUirenlentURS要求DeSign Doc. Name SeCtiOn if relevant 设计文件名称相关章节OK/ not OKACtiOII No. 措施编号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. 冷库的就地控制器Dlc应提供通讯接口给BMS用于对其监视包括运行状态 和故障报警的监视。FUnCtiOnal ReqUirement for ACCeSS AUthOrity 访问权限功能需求4.5.1OnIy authorized PerSOnnel is allowed access to Change the SettingS Of the PrOCeSS ParalneterS Of the COOlinS Imit COntrOIler.只有授权的人允许变更冷机控制器工艺参数的设置。4

29、.5.2The COld StOraSe Can Only be accessed by authorization. 进入冷库，必须要有授权。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 设计确认方案和报告冷库COld StOrage ROOmRz：版本：OOlURS ID 用户要求编号ReqUirenlentURS要求DeSign Doc. Name SeCtiOn if relevant 设计文件名称相关章节OK/ not OKACtiOII No. 措施编号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冷库室内温度必须保证产品是处于2-8。C的环境中，并且房间在下列情况下 都要保持在2-8摄氏度：房间内各部分各装载水平甚至当任何一台制冷系统岀故障的时候冷库初次的空载和满载期间的验证再验证的满载期间4.6.2The air-stream from the COOling Unit(S) exit must not hit the PrOdUCtS directly On the horizo

32、n IeVeL冷风机出口的冷风不能直接(水平方向)吹在产品上。4.6.3PlaCeS Where PrOdUCt must not be StOred must be marked 不能存放产品的地方必须标记。DeSign QUaIifiCatiOn PrOtOCOl and RePOrt 设计确认方案和报告冷库COld StOrage ROOmRz：版本：OOlURS ID 用户要求编号ReqUirenlentURS要求DeSign Doc. Name SeCtiOn if relevant 设计文件名称相关章节OK/ not OKACtiOII No. 措施编号4.6.4There must be Pet COntrOI. 需有昆虫和动物控制措施。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.不论门锁和读卡器处于何种状态，所有的门都可以从内部打开。COnClUSion： 结论Page 14 of 17LOGODeSign QUalifiCatiOn PrOtOCOl and RePOrt 设计确认方案