USP1058分析仪器确认中英文对照

1、 ANALYTICAL INSTRUMENT QUALIFICATION分析仪器的确认INTRODUCTION介绍A large variety of laboratory equipment, instruments, and computerized analytical systems, ranging from simple nitrogen evaporators to complex multiple-function technologies (see Instrument Categories), are used in the pharmaceutical industry

2、to acquire data to help ensure that products are suitable for their intended use. An analysts objective is to consistently obtain reliable and valid data suitable for the intended purpose. Depending on the applications, users validate their procedures, calibrate their instruments, and perform additi

3、onal instrument checks, such as system suitability tests and analysis of in-process quality control check samples to help ensure that the acquired data are reliable. With the increasing sophistication and automation of analytical instruments, an increasing demand has been placed on users to qualify

4、their instruments. 极其多种多样的实验室设备、仪器、计算机分析系统，从简单的氮吹仪到复杂的多功能技术（见仪器种类），被应用于制药工业，以取得数据来确保产品适合其预定用途。分析员的目标是持续地获得适合其意图的可靠和有效的数据。取决于具体的应用，使用者验证其方法、校准其仪器，并进行额外的仪器检查，例如系统适用性测试和中间质量控制检查样品的分析，以便帮助确保所获得的数据是可靠的。随着分析仪器的复杂性和自动化程度不断增加，使用者已经感受到了不断增加的确认其仪器的要求。Unlike method validation and system suitability activities,

5、 analytical instrument qualification (AIQ) currently has no specific guidance or procedures. Competing opinions exist regarding instrument qualification and validation procedures and the roles and responsibilities of those who perform them. Consequently, various approaches have been used for instrum

6、ent qualification, approaches that require varying amounts of resources and generate widely differing amount of documentation. This chapter provides a scientific approach to AIQ and considers AIQ as one of the major components required for generating reliable and consistent data. Note that the amoun

7、t of rigor applied to the qualification process will depend on the complexity and intended use of the instrumentation. This approach emphasizes AIQs place in the overall process of obtaining the reliable data from analytical instruments. 不同于验证和系统适用性工作，分析仪器的确认（AIQ）目前尚没有具体的指导方针或程序。关于仪器确认和验证程序，以及这些程序的执

8、行者的角色和职责，存在着相互冲突的多种观点。由此导致，多种方法已经应用于仪器确认，而这些方法要求使用的资源数量各异并产生数量差距很大的文档。此通则为AIQ提供了科学的方法，并将AIQ视为产生可靠和一致的数据所必需的主要组成部分之一。注意，应用到确认过程的严格程度将由该仪器的复杂性和预定用途来决定。这个方法强调了AIQ在从分析仪器中获得可靠数据的全过程中的位置。Validation versus Qualification验证对确认In this chapter, the term validation is used for manufacturing processes, analytica

9、l procedures, and software procedures and the term qualification is used for instruments. Thus, the phrase “analytical instrument qualification” (AIQ) is used for the process of ensuring that an instrument is suitable for its intended application. 在此通则中，验证一词用于生产工艺、分析方法、软件程序，而确认一词用于仪器。因此，“分析仪器的确认”（AI

10、Q）一词用于确保仪器适用于其预定用途的过程。COMPONENTS OF DATA QUALITY数据质量的组成部分There are four critical components involved in the generation of reliable and consistent data (quality data). Figure 1 shows these components as layered activities within a quality triangle. Each layer adds to the overall quality. Analytical i

11、nstrument qualification forms the base for generating quality data. The other components essential for generating quality data are analytical method validation, system suitability tests, and quality control checks samples. These quality components are described as below.在产生可靠和一致的数据（质量数据）的过程中涉及了四个重要的

12、组成部分。图1以层叠形式在质量三角形内展示了这些组成部分。每层相加构成了总体质量。分析仪器确认构成了产生质量数据的基础。作为质量数据产生的基础的其他组成部分为分析方法验证、系统适用性测试、质量控制检验样品。这些质量部分描述如下。Quality Control Check SamplesSystem Suitability TestsAnalytical Method ValidationAnalytical Instrument QualificationFigure 1. Components of data qualityAnalytical Instrument Qualificatio

13、n分析仪器确认AIQ is the collection of documented evidence that an instrument performs suitably for its intended purpose. Use of a qualified instrument in analyses contributes to confidence in the validity of generated data. AIQ是证明某个仪器表现得适合其预定用途的文件证据的汇总。在分析中使用确认过的仪器确保了对所生成数据的有效性的信心。Analytical Method Valida

14、tion分析方法验证Analytical method validation is the collection of documented evidence that an analytical procedure is suitable for its intended use. Use of a validated procedure with qualified analytical instruments provides confidence that the procedure will generate test data of acceptable quality. Addi

15、tional guidance on validation of compendial procedures may be found in the general information chapter Validation of Compendial Procedures . 分析方法验证是某个分析方法适合其预定用途的文件证据的汇总。使用确认过的分析仪器和验证过的方法确保了该方法将会产生质量可接受的测试数据的信心。关于药典方法的验证方法的额外指导原则可以在通则药典方法的验证中找到。System Suitability Tests系统适用性测试System suitability tests

16、 verify that the system will perform in accordance with the criteria set forth in the procedure. These tests are performed along with the sample analyses to ensure that the systems performance is acceptable at the time of the test. USP general chapter Chromatography presents a more detailed discussi

17、on of system suitability tests as related to chromatographic systems. 系统适用性测试证实该系统的表现将会符合此方法中设定的标准。这些测试与样品分析仪器进行，从而确保此系统的表现在测试的时候是可以接受的。USP通则色谱法呈现了对于色谱系统的系统适用性测试的更加具体讨论。Quality Control Check Samples质量控制检验样品Many analysts carry out their tests on instruments standardized using reference materials and/

18、or calibration standards. Some analysts also require the inclusion of quality control check samples to provide an in-process or ongoing assurance of the tests suitable performance. In this manner, AIQ and analytical method validation contribute to the quality of analysis before analysts conduct the

19、tests. System suitability tests and quality control checks help ensure the quality of analytical results immediately before or during sample analysis. 许多分析员在以标准物质和/或校准标准品进行标准化的仪器上进行他们的测试。一些分析员还要求加入质量控制检验样品，以便对此测试的适当表现提供中间或持续的保证。在这个方面，在分析员进行该测试之前，AIQ和分析方法验证就对分析质量起到了作用。系统适用性测试和质量控制检查，则在样品分析马上开始之前或在其过程

20、中，帮助确保分析结果的质量。ANALYTICAL INSTRUMENT QUALIFICATION PROCESS分析仪器确认程序The following sections address in detail the AIQ process. The other three components of building quality into analytical data - analytical method validation, system suitability tests, and quality control check samples - are not within

21、the scope of this chapter. 下面的章节具体解答了AIQ的过程。确保分析数据质量的其他3个组成部分，分析方法验证、系统适用性测试、质量控制检验样品，不在此通则的范围之内。Qualification Phases确认的阶段Instrument qualification is not a single continuous process, but instead results from several discrete activities. For convenience, these activities can be grouped into four phas

22、es: design qualification (DQ), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).仪器确认不是一个单独的连续过程，而是源自若干独立活动的结果。为方便起见，这些活动可以被归为4个阶段：设计确认（DQ）、安装确认（IQ）、运行确认（OQ）、性能确认（PQ）。Some AIQ activities cover more than one qualification phase, and analysts potential

23、ly could perform them during more than one of the phases (see Table 1). However, in many instances there is need for specific order to the AIQ activities; for example, installation qualification must occur first in order to initiate other qualification activities. The AIQ activities will be defined

24、and documented. 一些AIQ活动包括了超过一个确认阶段，并且分析员倾向于可以跨阶段进行这些活动（见表1）。但是，在很多情况下，AIQ活动有特定的顺序要求；例如，安装确认必须首先发生，以便启动其他确认活动。AIQ活动将被定义并以文件形式记录。Table 1. Timing, Applicability, and Activities for Each Phase of Analytical Instrument Qualification* Design QualificationInstallation QualificationOperational Qualification

25、Performance QualificationTiming and ApplicabilityPrior to purchase of a new model of instrumentAt installation of each instrument (new, old, or existing unqualified)After installation or major repair of each instrumentPeriodically at specified intervals for each instrumentActivitiesAssurance of manu

26、facturers DQDescriptionFixed parametersPreventive maintenance and repairsAssurance of adequate support availability from manufacturerInstrument deliveryEstablish practices to address operation, calibration, maintenance, and change controlInstruments fitness for use in laboratoryUtilities/facilityEnv

27、ironmentAssembly and installationNetwork and data storageSecure data storage, backup, and archiveInstallation verificationInstrument function testsPerformance checks*Activities under each phase are usually performed as given in the table. However, in some cases, it may be more appropriate to perform

28、 or combine a given activity with another phase. Such activities, spanning more than one qualification phase are shown as connected by double arrows. If an activity listed under a given phase is performed under another phase, it is not necessary to repeat the activity under the phase where the activ

29、ity is listed. Performing the activity is far more important than the phase under which the activity is performed.表1. 分析仪器确认每个阶段的时间表、实用性、活动设计确认安装确认运行确认性能确认时间表和实用性在购买新型仪器之前在安装每个仪器时(新的、旧的、或一直未经确认的)在每个仪器安装或大修之后每个仪器在规定的间隔定期进行活动确认制造商设计确认描述固定参数预防性保养和维修确认制造商可以给与充分支持仪器运送设立相关规程，以解决操作、校准、维护、变更控制仪器在实验室中使用的适用性公

30、用设施/设施环境组装与安装网络和数据储存安全的数据储存、备份、存档安装确认仪器功能测试性能测试在每个阶段下的活动通常按照表中列出地进行。但是，在某些情况下，可以更加适合进行或合并某个特定活动于其他阶段。这样跨域超过一个确认阶段的活动用双箭头连接来显示。如果某个列出于特定阶段的活动进行于另外一个阶段，没有必要在列出该活动的阶段重复进行。进行该活动要比该活动在那个阶段进行重要许多。DESIGN QUALIFICATION设计确认Design qualification (DQ) is the documented collection of activities that define the f

31、unctional and operational specifications of the instrument and criteria for the selection of the vendor, based on the intended purpose of the instrument. Design qualification (DQ) may be performed not only by the instrument developer or manufacturer but also may be performed by the user. The manufac

32、turer is generally responsible for robust design and maintaining information describing how the analytical instrument is manufactured (design specifications, functional requirements, etc.) and tested before shipment to users. Nonetheless, the user should ensure that commercial off-the-shelf (COTS) i

33、nstrument are suitable for their intended application and that the manufacturer has adopted a quality system that provides for reliable equipment. Users should also determine the manufacturers capability for support installation, services, and training. This determination might be aided by the users

34、 previous interaction with the manufacturer. 设计确认（DQ）是基于仪器预定用途，对仪器的功能与操作标准和提供商的选取标准做出规定的活动总汇，并以文件记录。设计确认（DQ）不仅可以由仪器开发者或制造商进行，也可以有使用者进行。制造商通常负责稳健设计和维护信息，描述该分析仪器如何制造（设计标准、功能要求等）在发给客户之前如何测试。虽然如此，使用者仍应该确保商用成品仪器适用于他们的预定用途，并且制造商已经采纳了能够保证仪器可靠的质量系统。使用者也应该确定制造商在辅助安装、服务、培训方面的能力。确定的过程可以借助使用者以前与制造商的互动交流。INSTALL

35、ATION QUALIFICATION安装确认Installation qualification (IQ) is the documented collection of activities necessary to establish that an instrument is delivered as designed and specified, and is properly installed in the selected environment, and that this environment is suitable for the instrument. IQ appl

36、ies to an instrument that is new or was pre-owned, or to any instrument that exists on site but has not been previous qualified. Relevant parts of IQ would also apply to a qualified instrument that has been transported to another location or is being reinstalled for other reasons, such as prolonged

37、storage. The activities and documentation typically associated with IQ are as follows. 安装确认（IQ）是对用于确定某个仪器按照设计和规定的方式运输并正确安装在选定的环境中，以及该环境适合于此仪器所必需的活动总汇，并以文件记录。IQ应用于某件仪器，其可以是新的或是二手的，或应用于任何已经在现场但是此前从未确认过的仪器。IQ的相关部分也会用于某个已经确认的设备，但是该设备经过运输至另外的一个场所或由于其他原因（例如，延长的存储）重新安装。通常与IQ相关的活动和文件如下。Description- Provide

38、a description of the instrument or the collection of instrument components, including its manufacturer, model, serial number, software version, and location. Use of drawings and flow chart where appropriate. 描述-提供该仪器或者仪器组成部分汇总的描述，包括其制造商、型号、编号、软件版本、放置位置。适当情况下使用图纸和流程图。Instrument Delivery- Ensure that

39、the instrument, software, manuals, supplies, and any other instrument accessories arrive as specified in the purchase order and that they are undamaged. For a pre-owned or existing instrument, manuals and documentation should be obtained. 仪器运输- 确保该仪器、软件、手册、供给品，以及其他仪器附件按照订单中规定的方式抵达，并且他们没有损坏。对于二手或已有的仪

40、器，手册和记录文件必须得到。Utilities/Facility/Environment-Verify that the installation site satisfactorily meets manufacturer-specified environmental requirements. 公用设施/设施/环境-证实安装区域令人满意地达到了制造商规定的环境要求。Assembly and installation- Assembly and install the instrument, and perform any preliminary diagnostics and testi

41、ng. Assembly and installation may be done by the manufacturer, vendor, specialized engineers, or qualified in-house personnel. Manufacturer-established installation tests and guides provide a valuable baseline reference for determining instrument acceptance. Any abnormal event observed during assemb

42、ly and installation merits documenting. Installation packages purchased from the manufacturer or the vendor may, however, need to be supplemented with user-specific criteria. 组装和安装- 组装和安装仪器，并进行任何预诊断和测试。组装和安装可以由其制造商、供应商、专业工程师、或有资质的内部员工来进行。对于确定仪器的验收，制造商确定的安装测试和指导提供了具有价值的基本参考。在组装和安装过程中观察到的任何异常事件均需以文件记录

43、。但是，购自制造商或供应商的安装包需要根据用户的具体标准进行补充。Network and Data Storage- Some analytical systems require users to provide network connections and data storage capabilities at the installation site. When required, connect the instrument to the network, and check its functionality. 网络和数据储存- 一些分析系统要求使用者在安装场所提供网络连接和数

44、据存储能力。当需要时，将仪器连接到网络，并检查其功能。Installation Verification- Perform the initial diagnostics and testing of the instrument after installation. 安装认证- 在安装之后，进行该仪器的初始诊断和测试。OPERATIONAL QUALIFICATION运行确认After a successful IQ, the instrument is ready for OQ testing. Operational qualification (OQ) is the document

45、ed collection of activities necessary to demonstrate that an instrument will function according to its operational specification in the selected environment. Testing activities in the OQ phase consist of these test parameters. 在成功的IQ之后，此仪器就可以进行OQ测试了。操作确认（OQ）是证实某个仪器将会在选定的环境中按照其操作规范运行所必需的活动总汇，并以文件记录。在

46、OQ阶段的测试活动包含了这些测试参数。Fixed Parameter- These tests measure the instruments non-changing parameter such as length, height, weight, voltage inputs, acceptable pressures, and loads. If the manufacturer-supplied specifications for these parameters satisfy the user, the test requirements may be waived. Howe

47、ver, if the user wants to confirm the parameters, testing can be performed at the users site. Fixed parameters do not change over the life of the instrument, and therefore never need redetermination. NOTE: These tests could also be performed during the IQ phase (see Table 1); if so, fixed parameters

48、 need not be redetermined as part of OQ testing.固定参数- 这些测试测量该仪器的不变参数，例如长度、高度、重量、输入电压、可接受压力、载荷等。如果由制造商提供的这些参数的规格令用户满意，可以放弃测试要求。但是，如果用户需要确认这些参数，可以在使用者的场地进行测试。固定参数在仪器的寿命周期内不会变化，并且因此不需重测。【注意：这些测试还可以在IQ阶段（见表1）进行；如果这样，固定参数作为OQ测试的一部分，无需重测。】Secure Data Storage, Backup, and Archiving- When applicable, test s

49、ecure data handling such as storage, backup, audit trails, and archiving at the users site according to written procedures. 安全数据存储、备份、存档- 当可行的时候，根据书面程序，在用户的场所测试安全数据处理工作，例如存储、备份、审计追踪、存档等。Instrument Function Tests- Instrument functions required by the user should be tested to verify that the instrumen

50、t operates as intended by the manufacturer. Manufacturer-supplied information is useful in identifying specifications for these parameters and in designing tests to evaluate the identified parameters. Users, or their qualified designees, should perform these tests to verify that the instrument meets

51、 manufacturer or user specifications in the users environment. 仪器功能测试- 使用者要求的仪器功能应该被测试，以确认该仪器能够按照制造商所预期地操作。制造商提供的信息有助于识别这些参数的规范，并帮助设计用于评估这些识别出来的参数的测试。使用者，或者他们的有资质的设计师，应该进行这些测试，以便证实该仪器在使用者的环境中达到了制造商或使用者的标准。The extent of OQ testing that an instrument undergoes depends on its intended applications. The

52、refore, no specific OQ tests for any instrument or application are offered in this chapter. 某个仪器经历的OQ测试的程度取决于其预定用途。因此，在此通则中没有为任何仪器或用途提供任何具体的OQ测试。Routine analytical tests do not constitute OQ testing. OQ tests are specifically designed to verify the instruments operation according to specifications i

53、n the users environment, and repeating the testing at regular intervals may not be required. However, when the instrument undergoes major repairs or modifications, relevant OQ and/or PQ tests should be repeated to verify whether the instrument continues to operate satisfactorily. If an instrument is

54、 moved to another location, an assessment should be made of what, if any, OQ test should be repeated. 日常分析检测不构成OQ测试。OQ测试是特别设计，用于确认在用户环境中该仪器根据其规范的运行情况，并且定且重复该测试可能没有必要。但是，当仪器经历大修或改装时，相关的OQ和/或PQ测试应该重复，以便确认该仪器是否继续令人满意地运转。如果某个仪器移到另一个位置，应该进行一项评估，以确定什么OQ测试应该被重复（如果确实有的话）。OQ tests can be modular or holistic.

55、 Modular testing of individual components of a system may facilitate interchanging of such components without requalification. Holistic tests, when involve the entire system, are also acceptable. OQ测试可以为模块式或整体式。系统中的单个组成部分的模块式测试可以方便这样的组成部分的交换，而无需重新确认。设计整个系统的整体式测试也是可以接受的。PERFORMANCE QUALIFICATION性能确认P

56、erformance qualification (PQ) is the documented collection of activities necessary to demonstrate that an instrument consistently performs according to the specifications defined by the user, and is appropriate for the intended use. After IQ and OQ have been performed, the instruments continued suit

57、ability for its intended use is demonstrated through performance qualification. The PQ phase may include the following parameters. 性能确认（PQ）是证实某个仪器持续地按照由用户定义的规范运行，并适合其预定用途的活动总汇，并以文件记录。在IQ和OQ已经执行之后，该仪器对其预定用途的持续适用性通过性能确认来证实。此PQ阶段可以包括下列参数。Performance Checks- Set up a test or series of tests to verify the acceptable performance of the instrument for its intended use. PQ tests are usually based on the instruments typical on-site applications and may consist of analyzing known components or standards. The tests should be based on good science and reflect the general intended use of the instrum