APPENDIX 6 GUIDELINES ONQUALIFICATION 附录6-确认指南
1. Principle 原则
2. Scope 范围
3. Glossary 术语
4. General 概述
5. User requirementspecifications 用户需求说明
6. Designqualification 设计确认
7. Factoryacceptance test and site acceptance test FAT和SAT
8. Installationqualification 安装确认
9. Operationalqualification 运行确认
10. Performancequalification 性能确认
11. Periodicreview and requalification 定期审核和再确认
1.PRINCIPLE原则
1.1 In principle,premises, systems, utilities and equipment should be appropriately designed, installed, qualified, operated, cleaned andmaintained to suit their intended purpose.
原则上，厂房、系统、公用设施和设备应进行适当的设计、安装、确认、运行、清洁和维护，以符合其预期目的。
1.2 Qualitymanagement systems should be in place to ensure that these remain in aqualifiedstate throughout their life cycle.
质量管理系统应该到位，以确保它们在整个生命周期中保持确认状态。
1.3 Productsshould be manufactured on qualified equipment.
产品应使用经确认的设备生产。
1.4 Manufacturerswho may use an alternative verification framework to achieve qualification should ensure the qualificationexpectations within this guide are satisfied.
生产商也可以使用另一种验证框架来完成确认，以确保满足本指南中的确认期望。
2. SCOPE 范围
2.1 Theseguidelines describe the general approach to qualification, for example,premises,systems, computerized system,utilities and equipment.
这些指南描述了确认的一般方法，例如厂房、系统、计算机化系统、公用系统和设备。
2.2 The principlesin these guidelines may also be applied to the qualification of instruments,analytical instruments and testing devices, where appropriate.
在适当情况下，这些指南的原则也可适用于仪器、分析仪器和测试装置的确认。
2.3 These mayinclude and are not limited to: certain rooms; water purification systems;cleaning systems; heating, ventilation and air conditioning systems; compressedair systems; gas systems;steam systems; as well as production equipment and analytical instruments.
这些可能包括但不限于:特定房间;水系统;清洗系统;HVAC系统;压缩空气系统;其他气体系统;蒸汽系统;以及生产设备和分析仪器。
2.4 Separateguidelines in this series address other principles in validation such asprocess validationand cleaning validation (see references at the end of this document).
本系列中单独的指南方针讨论了验证中的其他原则，如工艺验证和清洁验证(请参阅本文末尾的参考资料)。
2.5 The principlecan be used when de-commissioning equipment to show that it remains fit for its purpose throughout the life cycle.
当设备退役时，可以使用该原理来表明它在整个生命周期中始终适用其用途。
3. GLOSSARY 术语
computerizedsystem. A computerizedsystem collectively controls the performance andexecution of one or more automated processes and/or functions. It includescomputerhardware, software, peripheraldevices, networks and documentation, for example, manuals and standard operating procedures (SOPs), aswell as personnel interacting with hardware and software.
计算机化系统。计算机化系统集体控制一个或多个自动化过程和/或功能的性能和执行。它包括计算机硬件、软件、外围设备、网络和文件，例如手册和标准操作程序，以及与硬件和软件交互的人员。
designqualification. Documentedevidence that, for example, the premises, supporting systems, utilities and equipment have beendesigned for their intended purposes and in accordance with the requirements of goodmanufacturing practices (GMP).
设计确认。有文件证明，例如，厂房、支持系统、公用设施和设备是按照其预期目的和药品生产质量管理规范(GMP)的要求设计的。
factoryacceptance test. A testconducted, usually at the vendor’s premises, to verify that the system, equipment or utility, asassembled or partially assembled, meets approved specifications. (new)
工厂验收测试。一种测试，通常在供应商场所进行，以确认组装或部分组装的系统、设备或公用设施是否符合批准的规格。(新)
installationqualification. Theperformance of tests to ensure that the installations (such as machines, measuring devices, utilitiesand manufacturing areas) used in a manufacturing process are appropriately selected andcorrectly installed and operate in accordance with established specifications.
安装确认。确保在制造过程中使用的设备(如机器、测量设备、公用设施和制造区域)按照既定的规格被适当地选择，正确地安装和操作。
operationalqualification. Documentedverification that the system or subsystem performs as intended over all anticipatedoperating ranges.
运行确认。用文件来确认系统或子系统在所有预期的操作范围内按预期运行。
performancequalification. Documentedverification that the equipment or system operates consistently and givesreproducibility within defined specifications and parameters for prolonged periods. (In the context ofsystems, the term “process validation” may also be used.)
性能确认：有文件证明设备或系统运行一致，并在规定的规格和参数内提供长时间的重现性。(在系统上下文中，也可以使用“工艺验证”一词。)
site acceptancetest. A test conducted atthe site of use to verify that the system, equipmentor utility, as assembled or partially assembled meets approved specifications. (new)
现场验收测试：在使用现场进行的测试，以验证组装或部分组装后的系统、设备或公用设施是否符合批准的规格。(新)
system. A regulated pattern of interactingactivities and techniques that are united to form an organized whole.
系统：相互作用的活动和技术的规范模式，它们联合起来形成一个有组织的整体。
userrequirement specifications.An authorized document that defines the requirements for use of the system, equipment or utilityin its intended production environment. (amended)
用户需求说明：在预期的生产环境中定义系统、设备或公用设施使用要求的授权文件。(修改)
utility. A system consisting of one or morecomponents to form a structure designed to collectively operate, function or performand provide a service such as electricity, water, ventilation or other. (new)
公用设施。一种由一个或多个部件组成的系统，形成一种结构，其设计目的是共同操作、工作或提供服务，如电力、水、通风或其他。(新)
4. GENERAL 概述
Note: Theremainder of the text in these guidelines will refer to utilities and equipmentasexamples, even though theprinciples may be applicable to others such as premises and systems.
注:本指南的其余部分将以公用工程和设备为例，尽管这些原则可能适用于其他领域，如厂房和系统。
4.1 The validationmaster plan, or other relevant document, should specify the policy, organization, planning, scope and stagesapplied in qualification on site, and should cover, for example, production, quality control andengineering.
验证主计划或其他相关文件应详细说明在现确认中应用的政策、组织、计划、范围和阶段，并应包括，例如，生产、质量控制和工程。
4.2 Quality riskmanagement principles should be applied in qualification. These include:
确认应使用质量风险管理原则。包括：
· Aclear understanding of the system, and the role it plays in establishing/protecting the process andquality and all of the potential ways (risks) the process or quality could be impacted byfailures, events, errors, or time/use-based factors (deterioration, out of tolerance instruments,wear and tear, and so on);
系统的清晰的理解, 它在建立/保护工艺和质量中所起的作用，以及工艺或质量可能受到失败、事件、错误或基于时间/使用的因素(损坏、超出波动允许范围的仪器、磨损等)的影响的所有潜在方法(风险);
l Defining all of the Design, Procedural and/orQuality System Controls required to protect against these potential risks.These controls either mitigate/reduce the risks and/or detect the impact to quality orprocess – should the risk occur. (To ensure the “failure” does not impact final productquality);
定义所有的设计、程序和/或质量体系控制，以防止这些潜在的风险。这些控制可以减轻/减少风险和/或检测风险发生时对质量或工艺的影响。(确保“故障”不影响最终产品质量);
Compiling evidence during the design,engineering, commissioning and qualification to demonstrate that all of theserequired “controls” have been properly implemented and verified. (Including“function” where applicable – such as alarms on operatingparameters);
在设计、工程、调试和确认过程中收集证据，以证明所有这些必需的“控制”都得到了适当的实施和确认。(包括“功能”(如适用)-例如有关操作参数的报警);
· Appropriate control and oversight of changeonce the controls have been verified.
一旦控制得到确认，对变更进行适当的控制和监督。
4.3 The scope andextent of qualification and requalification should be determined based on the principles of impact assessment andrisk management principles.
确认和再确认的范围和程度应根据影响评估原则和风险管理原则确定。
4.4 Qualificationshould be executed by trained personnel. Training records should be maintained.
确认应由经过培训的人员执行。应保存培训记录。
4.5 Whereappropriate, new premises, systems, utilities and equipment should be subjectedtoall stages of qualification.This includes the preparation of user requirement specifications (URS),design qualification (DQ), installation qualification (IQ), operationalqualification (OQ) and performance qualification (PQ).
在适当情况下，新厂房、系统、公用设施和设备应进行所有的确认检查。包括编写用户需求说明(URS)、设计确认(DQ)、安装确认(IQ)、运行确认(OQ)和性能确认(PQ)。
4.6 Justificationshould be provided where it is decided that not all stages of qualification are required.
当决定不需要进行完整确认阶段时，应提供理由。
4.7 Qualificationshould be done in accordance with predetermined and approved qualification protocols. The protocolshould specify the prerequisites and test details, including acceptance criteria.
确认必须按照预先确定和批准的确认方案进行。方案应该指定先决条件和测试细节，包括验收标准。
4.8 The results ofthe qualification should be recorded and reflected in qualification reports.
确认的结果应当记录在案，并反映在确认报告中。
4. 9 Aqualification report prepared at the completion of each protocol or stage ofqualification (Installation/Operational/Performance) should include, orreference as appropriate, the following:
在每个确认报告或确认阶段(安装/运行/性能)完成时编制的确认报告应包括或酌情参考以下内容:
testresults, including supporting calculations, documentation and raw/original data,
测试结果，包括支持性计算、文件和原始数据。
test failures, 测试失败的情况
protocol departures, 方案偏离情况
recommendations and justification for issue resolution, and 问题解决的建议和理由
conclusions. 结论
4.10 There shouldbe a logical sequence for executing qualification, such as premises (rooms), thenutilities and equipment.
应该有一个执行确认的逻辑顺序，例如厂房(房间)，然后是公用设施和设备。
4.11 Normally,qualification stages should be sequential. (For example, operational qualificationshould follow after the successful completion of installation qualification.)In some cases, different stages of qualification may be executed concurrently.This should be justified and documented in the validation master plan (or qualificationprotocol).
通常，确认阶段应该是连续的。(例如，运行确认应该在成功执行安装确认后进行。)在某些情况下，确认的不同阶段可以同时执行。这应该在验证主计划(或验证方案)中证明并记录在案。
4.12 Equipmentshould be released for routine use only once there is documented evidence that the qualification has been successful.
只有在有文件证明确认成功执行的情况下，设备才应放行用于日常使用。
4.13 Certainstages of the qualification may be done by a supplier or a third party, subjecttothe conditions andresponsibilities as defined in a written agreement between the parties. The contract giver remains responsible toensure that the qualification is done in accordance with the principles of GMP.
确认的某些阶段可以由供应商或第三方完成，但须符合双方书面协议中规定的条件和责任。设备所有方仍有责任确保确认符合GMP的原则。
4.14 The relevantdocumentation associated with qualification, including SOPs, specifications and acceptance criteria, certificates andmanuals, should be available.
应提供与确认有关的相关文件，包括标准操作规程、规范和验收标准、证书和手册，应生效。
4.15 Utilities andequipment should be maintained in a qualified state and should be periodically reviewed for the need forrequalification. Requalification should be considered when changes are made.
公用设施和设备应保持在确认状态，并应定期审查是否需要再确认。如果有变更，应该考虑再确认。
5. USERREQUIREMENT SPECIFICATIONS用户需求说明
5.1 URS should beprepared for, but not limited to, utilities and equipment, as appropriate.
公用设施和设备应该准备URS，但不限于此。
5.2 URS should beused at later stages in qualification to verify that the purchased and supplied utility or equipment is inaccordance with the user’s needs.
URS在确认的后期阶段使用，以确定购买和提供的公用设施或设备是否符合用户的需要。
6. DESIGNQUALIFICATION 设计确认
6.1 DQ shoulddemonstrate that the system, as designed, is appropriate for its intended useasdefined in the URS.
DQ应证明系统的设计适用于URS所界定的预期用途。
6.2 A suitablesupplier should be selected and approved for the relevant utility or equipment.
对于相关的公用设施或设备，应选择批准的合适的供应商。
7. FACTORYACCEPTANCE TEST AND SITE ACCEPTANCE TEST
FAT和SAT
7.1 Where autility or equipment is assembled, or partially assembled at a site other thanthatof the purchaser or end-user,testing and verification may be done, based on quality risk management principles, to ensure that it isappropriate and ready for dispatch.
如果公用设施或设备是在买方或最终用户以外的地点组装或部分组装的，则可以根据质量风险管理原则进行测试和验证，以确保该设备是适当的，并已准备好进行分派。
7.2 The checks andtests during factory acceptance test (FAT) should be recorded.
工厂验收测试(FAT)期间的检查和测试应记录在案。
7.3 Theacceptability of the assembly and overall status of the utility or equipmentshould bedescribed in a conclusion ofthe report for the FAT, prior to shipment.
在装运前，关于FAT报告的结论应说明装配的可接受性和公用设施或设备的总体状况。
7.4 Tests, basedon quality risk management principles, may be performed to verify the acceptability of the utility or equipmentwhen it is received at the end-user. This is a site acceptance test (SAT).
根据质量风险管理原则，可以进行测试，以验证公用设施或设备在最终用户收到时是否可接受。这是一个现场验收测试(SAT)。
7.5 The results ofthe tests should be evaluated and the outcome of the acceptability of the utility or equipment should be recorded inthe conclusion section of the report for the SAT.
应评估测试结果，并在SAT报告的结论部分记录共用设施或设备的可接受标准的结果。
8. INSTALLATIONQUALIFICATION 安装确认
8.1 Utilities andequipment should be correctly installed, in an appropriate location.
公用设施和设备应正确安装在适当的位置。
8.2 There shouldbe documented evidence of the installation. This should be in accordance with the IQ protocol which contains all therelevant details.
应该有安装的证明文件。这应该符合IQ方案，它包含了所有相关的细节。
8.3 IQ shouldinclude identification and installation verification of relevant components identified, e.g. services, controls andgauges.
IQ应该包括相关组件的识别和安装确认，例如服务、控制和仪表。
8.4 Identifiedmeasuring, control and indicating devices, should be calibrated on site unless otherwise appropriately justified. Thecalibration should be traceable to national or international standards. Traceable certificates should beavailable.
用于测量、控制和指示装置应在现场进行校准，除非另有适当理由。校准应符合国家或国际标准。应提供可追溯的证书。
8.5 Deviations andnon-conformances, including those from URS, DQ and acceptance criteria specified and observed duringinstallation, should be recorded, investigated, and corrected or justified.
应记录、调查、纠正或证明偏差和不合格项，包括在安装过程中特定的和观察的URS、DQ和验收标准的偏差和不合格。
8.6 Normally, theoutcome of the IQ should be recorded in the conclusion of the report, before OQ is started.
通常情况下，IQ的结果应该记录在报告的结论中，并在OQ开始之前。
9. OPERATIONALQUALIFICATION 运行确认
9.1 Requirementsand procedures for operation (or use), calibration, maintenance and cleaning should normally be preparednormally before OQ and approved prior to PQ.
操作(或使用)、校准、维护和清洗的要求和程序通常应在OQ之前正常准备，并在PQ之前批准。
9.2 Utilities andequipment should operate correctly and their operation should be verified in accordance with an OQ protocol. OQ normallyfollows IQ but, depending on the complexity of utility or equipment, it may be performedas a combined installation/operation qualification (IOQ). This should be justified anddocumented in the validation master plan (or qualification protocol).
公用设施和设备应正确操作，其操作应根据OQ方案进行验证。OQ通常在IQ之后，但是，根据具体设施或设备的复杂性，它可以作为一个组合安装/运行确认(IOQ)来执行。这应该在验证主计划(或验证方案)中证明并记录在案。
9.3 OQ shouldinclude, but is not limited to, the following:
OQ应包括但不限于以下内容：
Ø tests that have been developed from theknowledge of processes, systems and equipment to ensure the utility orequipment is operating as designed; and
根据工艺、系统和设备知识进行的测试，以确保公用设施或设备按设计运行;和
Ø tests to confirm upper and lower operatinglimits, and/or “worst case” conditions.
测试以确定操作限度的上下限和/或“最坏情况”条件。
9.4 Training ofoperators for the utilities and equipment should be provided and training records maintained.
对公用设施和设备的操作人员进行培训，并保存培训记录。
9.5 Calibration,cleaning, maintenance, training and related tests and results should be verified to be acceptable.
校准、清洗、维护、培训及相关测试和结果应被确认是合格的。
9.6 Deviations andnon-conformances observed should be recorded, investigated and corrected or justified.
应记录、调查和纠正观察到的偏差和不符合项。
9.7 The resultsfor the verification of operation should be documented in the OQ report.
运行确认的结果应记录在OQ报告中。
The outcome of theOQ should be recorded in the conclusion of the report, normally before PQ is started.
通常情况下，在PQ开始之前，OQ的结果应该记录在报告的结论中。
10. PERFORMANCEQUALIFICATION 性能确认
10.1 PQ shouldnormally follow the successful completion of IQ and OQ. In some cases, it may be appropriate to perform PQ inconjunction with OQ or process validation. This should be justified and documented in the validationmaster plan (or qualification protocol).
PQ通常应在成功完成IQ和OQ后进行。在某些情况下，与OQ或工艺验证一起执行PQ可能是合适的。这应该在验证主计划(或验证方案)中证明并记录在案。
10.2 PQ shouldinclude, but is not limited to, the following: PQ可能包括但不限于以下内容：
Ø tests using production materials, qualifiedsubstitutes or simulated products proven to have equivalent behaviour undernormal operating conditions with worst case scenario and batch sizes whereappropriate; and
使用生产材料、合格的替代品或经证明具有同等性能的模拟产品进行测试，在正常运行条件下，在最坏的情况下进行测试，并在适当的情况下进行批量生产;
Ø tests should cover the intended operatingrange. 测试应该覆盖预期的操作范围。
10.3 Utilities and equipment shouldconsistently perform in accordance with their design specifications and URS.The performance should be verified in accordance with a PQ protocol.
公用设施和设备应始终按照其设计规范和URS执行。性能应该根据PQ方案进行验证。
10.4 There shouldbe records (for example, a PQ report) for the PQ to indicate the satisfactory performance over a predefined period oftime. Manufacturers should justify the period over which PQ is done.
应该有PQ的记录(例如，PQ报告)来表示在预定义的一段时间内的符合要求的性能。制造商应该证明PQ完成的时间是合理的。
11. PERIODICREVIEW AND REQUALIFICATION定期审核和再验证
11.1 Utilities andequipment should be maintained in a qualified state through the life cycle of the utility or equipment.
公用设施和设备在其生命周期内应保持在合格状态。
11.2 Utilities andequipment should be reviewed periodically to confirm that they remain in a qualified state or to determine the needfor requalification.
应定期审查公用设施和设备，以确认它们仍处于合格状态或确定需要再验证。
11.3 Where theneed for requalification is identified, this should be performed. 在确定需要再验证的地方，应该执行此操作。
11.4 Riskmanagement principles should be applied in the review and requalification andthepossible impact of smallchanges over a period of time should further be considered (such as, through change control).
风险管理原则应应用于审核和再确认，并应进一步考虑在一段时间内小的变更可能产生的影响(例如，通过变更控制)。
11.5 Riskmanagement principles may include factors such as calibration, verification, maintenance data and other information.
风险管理原则可能包括诸如校准、验证、维护数据和其他信息等因素。
11.6 Thequalification status and requalification due dates should be documented, forexample,in a qualification matrix,schedule or plan.
确认状态和再验证的截止日期应该被记录，例如，在确认矩阵，时间表或计划中。
11.7 In case autility or equipment in use is identified, where it had not been subjected to qualification, a qualification protocolshould be prepared where elements of URS, design specifications, operation and performanceare verified for acceptability. The outcome of this qualification should be recorded in areport.
如果确定使用中的公用设施或设备，而该设备尚未经过确认，则应编制确认方案，以核实URS、设计规范、运行和性能等要素的可接受标准。确认结果应该记录在报告中。
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