HVAC安装确认方案

有限公司InstallationQualificationProtocolforHVACSystem净化空调控制系统安装确认方案No./编号：HVAC-IQP-001Page/页码：1/29ProtocolApproval方案批准:批准指空调自控系统安装确认方案已经被审核并且是完整和可接受的。PROTOCOLREVIEW/APPROVALSIGNATURES方案审核/批准签字Date/日期Submittedby/提出人Reviewedby/审核人Approvedby/批准人有限公司InstallationQualificationProtocolforHVACSystem净化空调控制系统安装确认方案No./编号：HVAC-IQP-001Page/页码：2/29Content目录1.Purpose目的................................................................................................................................32.Scope范围.....................................................................................................................................33.Responsibilities职责....................................................................................................................34.References参考资料.....................................................................................................................55.Abbreviations缩略语....................................................................................................................56.Instruction介绍.............................................................................................................................56.1.厂房概要.........................................................................................................................................56.2.HVAC系统描述..............................................................................................................................66.3.控制系统描述..................................................................................................................................67.Pre-requirementsbeforeStartingIQ安装确认前的准备工作......................................................78.QualificationPlan验证计划..........................................................................................................79.IQ实施...........................................................................................................................................89.1.先决条件.........................................................................................................................................89.2.文件确认.......................................................................................................................................109.3.控制系统硬件架构的确认..............................................................................................................129.4.关键仪表检查................................................................................................................................159.5.接线和电气图的确认.....................................................................................................................199.6.控制系统软件配置检查..................................................................................................................219.7.静态人机界面的确认.....................................................................................................................249.8.公用设施的确认.............................................................................................................................2610.DeviationandChanges偏差和变更...........................................................................................281.1验证偏差.......................................................................................................................................281.2变更控制.......................................................................................................................................29有限公司InstallationQualificationProtocolforHVACSystem净化空调控制系统安装确认方案No./编号：HVAC-IQP-001Page/页码：3/291.Purpose目的厂房一洁净区房间是依照中国GMPD级区药品生产厂房设计标准设计，质检楼微生物实验室是依照中国GMPC级区药品生产厂房设计标准设计。各项指标：能够满足URS；符合车间产品生产工艺和GMP相应洁净度级别的要求。确保设计符合中国GMP的要求。满足相关设计规范、功能规范的要求与确认。2.Scope范围本设计方案适用于洁净房间的空调自控系统的安装确认。3.Responsibilities职责姓名（所在部门/职务）验证小组职务职责XXXX技术部/验证工程师组员负责起草验证方案，对相关人员进行培训。配合执行验证实施，并在方案的相应附录中记录检测结果。配合完成验证实施过程中发生的偏差调查、相关处理措施的执行，确保系统达到设计和验证标准要求。XXXX项目负责人组长负责组织验证方案审核和实施；负责组织协调设计确认进行；负责组织起草安装确认最终报告。XXXX生产部经理组员负责执行验证实施；提出生产对于空调系统的设计要求。有限公司InstallationQualificationProtocolforHVACSystem净化空调控制系统安装确认方案No./编号：HVAC-IQP-001Page/页码：4/29XXXQA部经理组员负责验证方案及验证记录的审核；负责对验证活动进行监督与管理；参与偏差调查，监督处理过程。XXXXQC部经理组员负责执行验证实施；提出生产对于空调系统的设计要求。有限公司InstallationQualificationProtocolforHVACSystem净化空调控制系统安装确认方案No./编号：HVAC-IQP-001Page/页码：5/294.References参考资料4.1.(CFDA)中国GMP2010年版4.2.欧盟药品法规第4卷GMP（人用和兽用药品）4.3.欧盟GMP的附录11-计算机化系统4.4.欧盟GMP的附录15-验证和确认4.5.((GAMP5)良好自动化生产实践指南-遵从GXP计算机化系统监管的风险管理方法，第5版4.6.用户需求说明5.Abbreviations缩略语缩略语定义HVACHeating,VentilatingandAirConditioning采暖通风与空调IQInstallationQualification安装确认GAMP5GoodAutomatedManufacturingPractice良好的自动化生产实践指南GMPGoodManufacturingPractice药品生产质量管理规范P&IDPipingandInstrumentsDiagram仪表和管路图DDCDirectDigitalControl直接数字控制控制器HMIHumanMachineInterface人机界面URSUserRequirementSpecification用户需求说明UPSUninterruptedPowerSupply不间断电源DIDigitalInput数字量输入DODigitalOutput数字量输出AIAnalogueInput模拟量输入AOAnalogueOutput模拟量输出6.Instruction介绍6.1.厂房概要有限公司InstallationQualificationProtocolforHVACSystem净化空调控制系统安装确认方案No./编号：HVAC-IQP-001Page/页码：6/29各技术区具体面积和洁净级别见下表：