诺华制药洁净房间空调系统确认程序(双语版)

1、密级：保密Classification: Confidential管理体系文件Standard Operating Procedure编号 ( SOP NO.) ： QMS-DL-SOP-016A空调系统确认程序Qualification Procedure for HVAC System姓名日期签名NameDateSignature编制 Author年月日审核 Reviewed by年月日审核 Reviewed by年月日批准 Approved by年月日批准 Approved by年月日变更记录Document Change Record版本修改条款及主要内容实施日期VersionChan

2、ge DescriptionEffective DateA新建 New2010 年 9 月 30 日此变更记录最少保存最近 3 次修改内容。 The latest three times modified content should be saved in this record.发放编号 (Issue No.) :实施日期（ Effective Date）: 2010 年 9 月 30 日管理体系文件 SOP编号 (No.) ：QMS-DL-SOP-015A空调系统确认程序页码 (Page) ：2/19Qualification Procedure forHVAC System1.目的Pu

3、rpose本 SOP 描述了洁净空调系统确认的一般要求，这些洁净空调为奥星北京制造中心的生产车间提供合格的洁净空气。本SOP 编写的基础是国际通行的项目管理V-model 模型和国际标准ISO14644 -1 -2 -3 -4 -5 -6。部分 1：洁净等级部分 2：测试和监视的技术规范，持续提供合格的洁净空气部分 3：测量学和测试方法部分 4：设计，建造和启动部分 5：操作部分 6：术语和定义ThisQualificationproceduredescribestherequirementsfortheQualificationof HVACsystems which providing q

4、ualified air to the process rooms in Austar BJMC production zone. The basis of this SOP is the V-model of international project management and international standard ISO 14644 -1 -2 -3 -4 -5 -6.Part 1: Classification of air cleanlinessPart 2: Specifications for testing and monitoring to prove contin

5、ued compliance with ISO14644-1Part 3: Metrology and test methodsPart 4: Design, construction and start-upPart 5: OperationsPart 6: Terms and definitions2. 范围 Scope本确认程序用于奥星北京制造中心的空调系统的确认。本SOP的范围限定在空调系统的物理界限，空调系统确认的范围物理界限定义如下：? 空调机组? 空气处理单元? 空气处理设备，例如：加热器，表冷器，除湿器，加湿器2管理体系文件SOP编号 (No.) ：QMS-DL-SOP-015

6、A空调系统确认程序页码 (Page) ：3/19Qualification Procedure forHVAC System?外部提供热源和冷源的接口部分，例如蒸汽，热水，冷冻水?控制的区域和房间?送回风管道?控制系统（例如： PLC, PLC /SCADA,DDC等）本确认程序包括项目阶段的确认活动（设计确认，安装确认，操作确认，运行确认），还包括运行阶段的再确认。This Qualification procedure applies to the qualification activities of HVAC systems in AustarBJMC. The scope of th

7、is SOP is limited to the physical boundaries of the HVAC system. The Physical boundaries are defined as follows:? Air handling units (AHUs)? Air conditioning units (ACUs)? Air treatment equipment (e.g., heating/cooling, dehumidification, humidification).? The interface of externally supplied heating

8、 and cooling sources such as steam, hot water, or chilled water.? Controlled areas/rooms are included? Supply air and return air duct work up to, inside rooms or controlled areas.? Control System Installation Testing for Computerized Systems (i.e., PLC, PLC /SCADA, DDC, etc.)This Qualification proce

9、dure includes qualification activities (DQ, IQ, OQ, PQ) during projectphase, and requalification during operation phase.3. 职责和权限 Responsibility3.1项目工程部Project & Engineering Department经理Manager? 编制用户需求描述 URS ；? 确定空调系统的技术参数，例如：洁净等级，风量，换气次数，压差，温湿度，布置形式，组成，布局 ;? 编制施工图；? 设备参数确定，设备选型；3管理体系文件 SOP编号 (No

10、.) ：QMS-DL-SOP-015A空调系统确认程序页码 (Page) ：4/19Qualification Procedure forHVAC System? 编制系统功能描述 FS ；? Work out URS;? Confirm the technology parameters of HVAC System, such as, Classification of air cleanliness, air volume, air change rate, pressure differential, temperature, relative humidity, type, comp

11、onents specification, layout;? Work out construction drawings;? Confirm the technology parameters of equipments, confirm the model of equipments.? Work our FS.项目主管project supervisor? 编制 IQ 文件；? 组织 IQ 实施。? Work out IQ documents;? Implement IQ activities.暖通技术员HVAC Technical? 编制 DQ ，OQ，PQ 文件；? 组织 DQ ，O

12、Q，PQ 实施。? Work out DQ ，OQ ， PQ documents;? Implement DQ ， OQ ，PQ activities. 3.2 动力设备部 Utility & Equipment Department经理Manager? 编写操作，监视，维护保养SOP ；? 培训操作工。? Work out SOP of operation, monitoring and maintenance;? Training operator.校验技术员Calibration technical? 确保校验设备仪器的有效性；? 进行校验仪表的校验确认分析；? 校验实施。4管理

13、体系文件SOP空调系统确认程序Qualification Procedure forHVAC System? Guarantee the calibration instruments to be available;? Perform the Sensors Risk Assessment.? Implement Calibration activities.维护保养组Maintenance Team? 执行 IQ, OQ ， PQ 中的具体工作；? 执行校验的具体工作；? 执行再确认工作。?Implement the physical activities during IQ, OQ， P

14、Q;? Implement the physical activities of calibration;? Implement the Re-qualification.编号 (No.) ：QMS-DL-SOP-015A页码 (Page) ：5/193.3动力工程部Utility & Engineering Department;经理Manager? 本 SOP的编制和升级；? 编写确认方案；? 确认工作的总协调；? 培训人员；? 批准和确认“确认文件” ；? 编写批准各阶段释放文件；? 编写确认报告。? Work out this SOP , and revised;? Work

15、out qualification protocol;? Coordination of all qualification activities;? Training of internal maintenance personnel;? Approval and review all qualification documents;? Work out release report for every qualification phase and approval it;? Work out qualification report.设备技术员Equipment Technical? 技

16、术资料的收集，整理，归档；5管理体系文件SOP空调系统确认程序Qualification Procedure forHVAC System? 确认文件的收集，整理，归档；? 确认工作的协调；? 参与 DQ ， IQ， OQ ， PQ 各阶段的工作。? Collection, settle and file the technology documents;? Collection, settle and file the qualification documents;? Coordination;编号 (No.) ：QMS-DL-SOP-015A页码 (Page) ：6/19?Take pa

17、rt in activities of DQ， IQ ，OQ ， PQ3.4Quality Assurance:? Ensuring that the Qualification SOP complies with the requirements of cGMP;? Implementation of the H13 Filter Leakage Test, Particle Count Test, Microbiological test required for the Qualification procedure;? Evaluation of the test results;?

18、确保本确认 SOP 符合 cGMP 的要求；? 执行 H13 高效过滤器泄漏检测，尘埃粒子计数检测，微生物检测，确认程序要求的；? 评价检测结果。4. 工作程序 Procedure4.1 常规需求 General Requirement?洁净空调系统要符合中国的GMP ，也要符合cGMP , 例如： FDA, WHO ,MHRA, TGA等机构。?The HVAC system should comply with local Chinese GMP, as well as cGMP， agenciessuch FDA, WHO, MHRA, TGA etc.4.2 洁净空调系统确认Quali

19、fication of HVAC System确认基于V-model模式，根据奥星北京制造中心的要求，以下步骤是确认工作的基础内容，必须要遵循。文件的内容在确认方案中定义。? 用户需求描述；? 风险评估? 设计确认? 安装确认6管理体系文件 SOP编号 (No.) ：QMS-DL-SOP-015A空调系统确认程序页码 (Page) ：7/19Qualification Procedure forHVAC System? 操作确认? 运行确认? 确认报告在运行确认和微生物检测执行之前，DQ ， IQ 和 OQ 必须完成，并没有质量关键性任务遗留。The Qualification should

20、be carried out based on the V-model.ThebelowbasicstepsshouldbefollowedforQualificationwithintheAustarBJMCrequirements. The content of the documents it should be defined in the Qualification Protocol.? User Requirements Specifications (URS)? Risk Assessment (RA)? Design Qualification (DQ)? Installati

21、on Qualification (IQ)? Operational Qualification (OQ)? Performance Qualification (PQ)? Qualification reportThe HVAC system qualification (DQ, IQ, and OQ) must be completed, and there must be noquality-criticaltaskspending,beforePerformanceQualification(PQ)is carriedout withtherelevant microbiologica

22、l tests.4.3 设计确认Design Qualification（ DQ ）空调系统的DQ 文件要满足URS 和 GMP 风险评估。 DQ 确认详细的技术设计。设计/工程文件必须被奥星的动力工程部的空调工程师和动力工程师检查并批准。是否需要其它部门的检查批准根据需要决定，例如HSE ，生产， QA 等。图纸，文件和数据首次批准后，变更控制程序将贯穿整个项目生命周期。在设计确认阶段，供应商提供的技术参数要认真地与URS 比较。DQ 文件至少要包括以下文件，部分文件将在下一阶段确认工作中被使用。? 工艺流程图? 部件技术参数? 功能描述? 传感器风险评估7管理体系文件 SOP编号 (No.

23、) ：QMS-DL-SOP-015A空调系统确认程序页码 (Page) ：8/19Qualification Procedure forHVAC System? 报警列表在确认文件列表中定义的文件必须被确认，并存档在测试文件夹。全部的设计文件加盖DQ 章，并相关人员签字，设计被确认；DQ 释放文件被大家批准后，工作完成。DQ documents that the design of HVAC system fulfills the URS and GMP Risk Assessment.DQ confirms the details of the technical design.Design

24、/ Engineeringdocumentsmustbe approvedandcheckedagainstthe identifiedcritical elements by the responsible Utility engineer or the HVAC engineer.By any other department (i.e. HSE, Production, QA, etc.) as deemed necessary.After first approval, each document, drawing or data must follow approved change

25、 control procedures throughout the project life cycle.During the Design Qualification (DQ), the supplier s offered specification is compared withthe approved URS.TheDQ documentations shouldatleast includethe blow files,those documentspartiallyrequired for the next qualification steps.?PID,?Component

26、s Specification,?Function Specification.?Sensor Risk Assessment?Alarm ListAllrelevant designdocuments,aredefined in the QualificationDocuments List,shall bequalified and filed in the Test Binder.The Design is qualified when all design documents are marked with a signed DQ stamp and approved with app

27、roval signatures. The DQ is completed when the DQ Release Form is signed by all relevant approvers.4.4 安装确认Installation Qualification(IQ)IQ 由一系列的测试组成，这些测试证明系统被正确地安装在了现场。三个问题要考虑，全部部件被安装了，正确的部件被安装了，部件被正确地安装了。8管理体系文件SOP空调系统确认程序Qualification Procedure forHVAC System编号 (No.) ：QMS-DL-SOP-015A页码 (Page) ：9/

28、19IQ contains a series of tests which documents that the system has been appropriately installed on Site. Three things should be considered, all components have been installed, correct components have been installed, and components correctly have been installed.IQ 工作开展的前提条件：? DQ 释放文件必须被批准；? 确认文件列表中的

29、全部文件必须有效，并存档在测试文件夹；? 全部 IQ 测试的技术规定必须被奥星的专业工程师批准，测试工作才能开始；? 全部的测试仪器必须被校验，有校验证书，并在有效期内；? 在 IQ 执行过程中发现的偏差按偏差处理程序处理。IQ pre-requisites:? The DQ release form has to be signed by all relevant approvers?All documents on theQualification Documents List must be availableand filedin theTest Binder? All IQ Test

30、 Specifications have to be approved by Austar Discipline Engineer before test activities can begin?All test instruments shall be calibrated and have calibration certificates， its available.? All deviations found during IQ execution will be handled according to the deviation management以下的确认活动是IQ 的典型工

31、作。该列表不是测试和评价一个系统的最小要求，可能会要求增加，列表中的工作也可能被删减和修改，根据风险评估来决策，在确认方案中规定：? 校验列表? 校验记录? 空调机组到场验收? 空调机组安装检查? 风机和马达安装检查? 过滤器安装检查9管理体系文件 SOP编号 (No.) ：QMS-DL-SOP-015A空调系统确认程序页码 (Page) ：10/19Qualification Procedure forHVAC System? 风管清洁记录? 风管巡线检查? 风管压力测试? 冷冻水管道巡线检查? 冷冻水管道压力测试? 风阀控制器功能确认? 水阀功能确认? 接线巡线检查IQ 释放文件被批准后，

32、IQ 工作完成。The following qualification activities are typically defined in the IQ. This list is not intended tobe a requirement for the minimum testing and evaluation for a system. Additional activities maybe required or activities in this list may be deleted or modified, depending on the particular re

33、quirements and configuration of the system as it may be deemed from the RA and stipulated in the Q. Protocol.? Calibration List? Calibration Record? AHU SAT? AHU Installation check? Fans & Motor installation check? Filters Installation check? Air Duct Cleaning Record? Air Duct Walk-down Check? A

34、ir Duct Pressure Test? Chiller Water Pipe Walk-down Check? Chiller Water Pipe Pressure Test? Function Verification of Damper Controller? Function Verification of Control Valves? Wiring/Pneumatic Diagram Walk-down Check10管理体系文件 SOP编号 (No.) ：QMS-DL-SOP-015A空调系统确认程序页码 (Page) ：11/19Qualification Procedu

35、re forHVAC SystemThe IQ is complete when the IQ Release Form is signed by all relevant approvers.4.5 操作确认Operation Qualification(OQ)操作确认由一系列的测试组成，这些测试证明系统的功能能够按照功能描述一样执行；OQ 工作开展的前提条件：? IQ 释放文件必须被批准；? 确认文件列表中的全部文件必须有效，并存档在测试文件夹；? 全部 OQ 测试的技术规定必须被奥星的专业工程师批准，测试工作才能开始；? 全部的测试仪器必须被校验，有校验证书；? 系统调试完成操作确认工作

36、分两阶段执行：空调机组部分和空调自控系统。操作确认的工作如下表所列：? 空气流量和换气次数测试? 房间压差测试? 过滤器压差测试? H13 过滤器泄漏测试? 报警测试? PLC 程序备份和恢复测试? 控制功能测试? 维护保养和操作手册? 培训记录OQ contains a series of testswhich documents that the system s function performs asdescribed in the Functional Specification.OQ pre-requisites:11管理体系文件 SOP编号 (No.) ：QMS-DL-SOP-0

37、15A空调系统确认程序页码 (Page) ：12/19Qualification Procedure forHVAC System? The IQ release form has to be signed by all relevant approvers.?All documents on theQualification Documents List must be availableand filedin theTest Binder?All OQ Test Specifications have to be approved byAustar Discipline Engineer

38、beforetest activities can begin? All test instruments shall be calibrated and have calibration certificates? The system is commissionedThe OQ will be executed in two phases: HVAC equipment and HVAC automation system.OQ tests are listed in the OQ Test Specification as below.? Air volumes and Air Chan

39、ges Rates Test? Room Differential Pressure Tests? Filter Differential Pressure Test? H13 Filter Leakage Test? Alarm Test? PLC Program Backup and Recovery Test? Controller Function Specification Test? Maintenance and Operational Manual? Austar Training Record在 OQ 执行期间发生的任何偏差按偏差管理流程处理。OQ 释放文件被批准后，OQ 工

40、作完成。All deviations found during OQ execution will be handled according to the deviationmanagement.The OQ is complete when the OQ Release Form is signed by all relevant approvers.4.6 运行确认Performance Qualification (PQ)运行确认包括一系列的测试，这些测试证明空调系统和连接的房间表现符合洁净区域的设计和 URS 的要求。12管理体系文件 SOP编号 (No.) ：QMS-DL-SOP-0

41、15A空调系统确认程序页码 (Page) ：13/19Qualification Procedure forHVAC SystemPQ 工作开展的前提条件：? OQ 释放文件必须被批准；? 确认文件列表中的全部文件必须有效，并存档在测试文件夹；? 全部 PQ 测试的技术规定必须被奥星的专业工程师批准，测试工作才能开始；? 全部的测试仪器必须被校验，有校验证书；?洁净空调系统和连接的房间必须根据相关SOP 清洁并检查；运行确认工作分两阶段执行：静态和动态。PQ contains a series of tests which documents that the HVAC system and

42、the connectedrooms performance are in compliance with the Zoning Diagram and the URS.PQ pre-requisites:? The OQ release form has to be signed by all relevant approvers? All documents on the Qualification Document List must be available and filed in the Test Binder? All PQ Test Specifications have to

43、 be approved by Austar Discipline Engineer before test activities can begin? All test instruments shall be calibrated and have calibration certificates? The HVAC system and the connected rooms must be cleaned and checked according to approved cleaning SOPs.The PQ will be executed in two phases: PQ a

44、t rest and PQ in operation.静态 PQPQ at rest静态 PQ 应该包括以下测试：? 换气次数? 温湿度测试13管理体系文件 SOP编号 (No.) ：QMS-DL-SOP-015A空调系统确认程序页码 (Page) ：14/19Qualification Procedure forHVAC System? 房间压差测试? 尘埃粒子计数检测? 微生物检测在静态 PQ 执行过程中发生的任何偏差都要按偏差处理流程处理。静态 PQ 释放文件被批准，静态PQ 工作结束。PQ at rest should include the listed tests in the P

45、Q Test Specification.? Determination of Air Change Rates? Temperature and Relative Humidity test? Room Differential Pressure test? Particle Count Test? Microbiological TestAll deviations found during PQ“ at rest” execution will be handled according to the deviationhandling.The PQ at rest is complete

46、 when the PQ at rest Release Form is signed by all relevant approvers.动态 PQPQ in operation动态 PQ 应该包括一下测试：? 温湿度测试? 房间压差测试? 尘埃粒子计数检测? 微生物检测动态 PQ 在常规操作条件下执行。在动态 PQ 执行过程中发生的任何偏差都要按偏差处理流程处理。14管理体系文件 SOP编号 (No.) ：QMS-DL-SOP-015A空调系统确认程序页码 (Page) ：15/19Qualification Procedure forHVAC System动态 PQ 释放文件被批准，动态

47、PQ 工作结束。PQ in operation should include the listed tests in the PQ Test Specification.? Temperature and Relative Humidity test? Room Differential Pressure test? Particle Count Test? Microbiological TestPQ in operation shall be executed under normal operation conditions.All deviations found during PQ“

48、 in operation” execution will be handledccoring to thedeviation handling.The PQ in operation is complete when the PQ in operation Release Form is signed by allrelevant approvers.4.7 确认报告Qualification Report静态 PQ 完成后，确认报告开始准备，总结DQ ， IQ， OQ 和静态 PQ 的活动和测试结果。确认报告确认在确认方案中描述的确认工作，除动态PQ 外，已经全部成功实施，并且符合接受标准

49、。况且，全部的偏差已经处理并成功关闭。动态 PQ 完成后，一份终版的确认报告将准备，总结动态PQ 的全部活动和结果。批准的确认报告和终版的报告证明确认工作已经完成，并且系统完全符合要求。When the PQ“ at rest” is completed, the Qualification Report (QR) will be prepared, and it willsummarize all qualification activities and results from DQ, IQ,OQ and PQ “ at rest“.The Qualification Report verifies that all qualification activities described in the QualificationPlan, except PQ“ in operation“ , have been successfully performed and fulfills the accept criteria.Further more, that all observed deviations have been handled and closed successfully.After the PQ“ in operation“ , a Final R