2022年USP分析仪器确认中英文对照.pdf

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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 analyst s 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 addi

3、tional 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 qualif

4、y 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精品资料 - - - 欢迎下载 - - - - - - - - - - - 欢迎下载 名师归纳 - - - - - - - - - -第 1 页，共 43 页 - - - - - - - - - - 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

5、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, analytical instrument qualification (AIQ) currently has no specific guidance or procedures. Competing opinions exist regarding instrument qualification and validation procedures and the roles

6、and responsibilities of those who perform them. Consequently, various approaches have been used for instrument 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 A

7、IQ as one of the major components required for generating reliable and consistent data. Note that the amount 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 th

8、e reliable data from analytical instruments. 精品资料 - - - 欢迎下载 - - - - - - - - - - - 欢迎下载 名师归纳 - - - - - - - - - -第 2 页，共 43 页 - - - - - - - - - - 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AI

9、Q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, analytical procedures, and software procedures and the term qualification is used for instruments.

10、 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”（AIQ）一词用于确保仪器适用于其预定用途的过程。精品资料 - - - 欢迎下载 - - - - - - - - - - - 欢迎下载 名师归纳 - - - - - - - - -

11、-第 3 页，共 43 页 - - - - - - - - - - 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 1shows these components as layered activities within a quality triangle. Each layer adds to the overall quality. A

12、nalytical instrument 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）

13、 的过程中涉及了四个重要的组成部分。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。精品资料 - - - 欢迎下载 - - - - - - - - - - - 欢迎下载 名师归纳 - - - - - - - - - -第 4 页，共 43 页 - - - - - - - - - - Analytical Instrument Qualification分析仪器确认AIQ is the collection of docum

14、ented 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 Validation分析方法验证Quality 精品资料 - - - 欢迎下载 - -

15、 - - - - - - - - - 欢迎下载 名师归纳 - - - - - - - - - -第 5 页，共 43 页 - - - - - - - - - - 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

16、 that the procedure will generate test data of acceptable quality. Additional 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

17、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 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 te

18、st. USP general chapter Chromatography presents a more detailed discussion of system suitability tests as related to chromatographic systems. 精品资料 - - - 欢迎下载 - - - - - - - - - - - 欢迎下载 名师归纳 - - - - - - - - - -第 6 页，共 43 页 - - - - - - - - - - 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

19、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/or calibration standards. Some analysts also require the inclusion of quality control check samples to provide an in-process o

20、r ongoing assurance of the test s suitable performance. In this manner, AIQ and analytical method validation contribute to the quality of analysis beforeanalysts conduct the tests. System suitability tests and quality control checks help ensure the quality of analytical results immediately beforeor

21、duringsample 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中，精品资料 - - - 欢迎下载 - - - - - - - - - - - 欢迎下载 名师归纳 - - - - - - - - - -第 7 页，共 43 页 - - - - - - - - - - 帮助确保分析结果的质量。ANALYTICAL I

22、NSTRUMENT 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 the scope of this chapter.

23、 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 phases: design qualification

24、(DQ), installation qualification (IQ), operational qualification (OQ), and performance qualification 精品资料 - - - 欢迎下载 - - - - - - - - - - - 欢迎下载 名师归纳 - - - - - - - - - -第 8 页，共 43 页 - - - - - - - - - - (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（ P

25、Q ） 。Some AIQ activities cover more than one qualification phase, and analysts potentially 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

26、in order to initiate other qualification activities. The AIQ activities will be defined 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 Inst

27、rument Qualification* 精品资料 - - - 欢迎下载 - - - - - - - - - - - 欢迎下载 名师归纳 - - - - - - - - - -第 9 页，共 43 页 - - - - - - - - - - Design QualificationInstallation QualificationOperational QualificationPerformance QualificationTiming and ApplicabilityPrior to purchase of a new model of instrumentAt installat

28、ion of each instrument (new, old, or existing unqualified)After installation or major repair of each instrumentPeriodically at specified intervals for each instrumentActivitiesAssurance of manufacturers DQDescriptionFixed parametersPreventive maintenance and repairsAssurance of Instrument Establish

29、精品资料 - - - 欢迎下载 - - - - - - - - - - - 欢迎下载 名师归纳 - - - - - - - - - -第 10 页，共 43 页 - - - - - - - - - - adequate support availability from manufacturerdeliverypractices to address operation, calibration, maintenance, and change controlInstrument s fitness for use in laboratoryUtilities/facilityEnvironm

30、entAssembly and installationNetwork and data storageSecure data storage, backup, and archive精品资料 - - - 欢迎下载 - - - - - - - - - - - 欢迎下载 名师归纳 - - - - - - - - - -第 11 页，共 43 页 - - - - - - - - - - Installation verificationInstrument function testsPerformance checks*Activities under each phase are usuall

31、y performed as given in the table. However, in some cases, it may be more appropriate to perform 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

32、 under another phase, it is not necessary to repeat the activity under the phase where the activity 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在 安装 每 个在每 个 仪 器每个仪器在精品资料 - - - 欢迎下载

33、 - - - - - - - - - - - 欢迎下载 名师归纳 - - - - - - - - - -第 12 页，共 43 页 - - - - - - - - - - 仪器之前仪 器 时 ( 新的、旧的、或一 直未 经 确认的)安装 或 大 修之后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用设施 / 设施环境组装与安装精品资料 - - - 欢迎下载 - - - - - - - - - - - 欢迎下载 名师归纳 - - - - - - - - - -第 13

34、 页，共 43 页 - - - - - - - - - - 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

35、activities that define the functional 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 perfor

36、med 精品资料 - - - 欢迎下载 - - - - - - - - - - - 欢迎下载 名师归纳 - - - - - - - - - -第 14 页，共 43 页 - - - - - - - - - - by the user. The manufacturer is generally responsible for robust design and maintaining information describing how the analytical instrument is manufactured (design specifications, functional re

37、quirements, etc.) and tested before shipment to users. Nonetheless, the user should ensure that commercial off-the-shelf (COTS) instrument are suitable for their intended application and that the manufacturer has adopted a quality system that provides for reliable equipment. Users should also determ

38、ine the manufacturer s capability for support installation, services, and training. This determination might be aided by the user s 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

39、（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。精品资料 - - - 欢迎下载 - - - - - - - - - - - 欢迎下载 名师归纳 - - - - - - - - - -第 15 页，共 43 页 - - - - - - - - - - INSTALLATION QUALIFICATION安装确认Installation qualification (IQ) is th

40、e 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 applies to an instrument that is new or was pre-owned, or to any

41、 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 storage. The activities and documentation typically associat

42、ed 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。精品资料 - - - 欢迎下载 - - - - - - - - - - - 欢迎下载 名师归纳 - - - - - - - - - -第 16 页，共

43、 43 页 - - - - - - - - - - Description- Provide 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。

44、适当情况下使用图纸和流程图。Instrument Delivery - Ensure that 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、

45、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精品资料 - - - 欢迎下载 - - - - - - - - - - - 欢迎下载 名师归纳 - - - - - - - - - -

46、第 17 页，共 43 页 - - - - - - - - - - 定的环境要求。Assembly and installation- Assembly and install the instrument, and perform any preliminary diagnostics and testing. Assembly and installation may be done by the manufacturer, vendor, specialized engineers, or qualified in-house personnel. Manufacturer-establ

47、ished installation tests and guides provide a valuable baseline reference for determining instrument acceptance. Any abnormal event observed during assembly and installation merits documenting. Installation packages purchased from the manufacturer or the vendor may, however, need to be supplemented

48、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。 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 精品资料 - - - 欢迎下载 - - - - - - - - - - - 欢迎下载 名师归纳 - -

49、 - - - - - - - -第 18 页，共 43 页 - - - - - - - - - - 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据存储能力。当需要时，将仪器连接到网络，并检查其功能。Installation

50、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 documented collection of activities necessary t