USP分析仪器确认中英文对照.docx

1、USP分析仪器确认中英文对照 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 multiplefunction technologies (see Instrument Categories）， are used in the pharmaceuti

2、cal industry 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 p

3、erform additional 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 user

4、s to qualify 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 suitabilit

5、y activities， 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 use

6、d 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 AIQ as one of the major components required for generating reliable and consistent data。 Note t

7、hat 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 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

8、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 process

9、es， analytical 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

10、,“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.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.

11、 Analytical 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

12、)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。Quality Control Check SamplesSystem Suitability TestsAnalytical Method ValidationAnalytical Instrument QualificationFigure 1. Components of data qualityAnalytical Instrument

13、 Qualification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

14、Method Validation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

15、quality. Additional guidance on validation of compendial procedures may be found in the general information chapter Validation of Compendial Procedures 1225。 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1225中找到。System Suitability Tests系统适用性测试Sys

16、tem 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 test。 USP general chapter Chromatography 呈现了对于色谱系统的系统

17、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 inprocess or ongoing assurance of the test

18、s suitable performance. In this manner, AIQ and analytical method validation contribute to the quality of analysis before analysts conduct the 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

19、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,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 buil

20、ding quality into analytical data - analytical method validation, system suitability tests, and quality control check samples - are not within 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 s

21、ingle continuous process， but instead results from several discrete activities. For convenience， these activities can be grouped into four phases: 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

22、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 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; fo

23、r example, installation qualification must occur first 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

24、， and Activities for Each Phase of Analytical Instrument Qualification* Design QualificationInstallation QualificationOperational QualificationPerformance QualificationTiming and ApplicabilityPrior to purchase of a new model of instrumentAt installation of each instrument （new， old， or existing unqu

25、alified）After installation or major repair of each instrumentPeriodically at specified intervals for each instrumentActivitiesAssurance of manufacturers DQDescriptionFixed parametersPreventive maintenance and repairsAssurance of adequate support availability from manufacturerInstrument deliveryEstab

26、lish practices to address operation, calibration, maintenance, and change controlInstruments fitness for use in laboratoryUtilities/facilityEnvironmentAssembly and installationNetwork and data storageSecure data storage, backup, and archiveInstallation verificationInstrument function testsPerformanc

27、e checksActivities under each phase are usually 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 ac

28、tivity listed under a given phase is performed 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

29、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

30、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 functional and operational specifications of the instrument and criteria for the selection of the vendor， based on the intended purpose of the instrument. Desi

31、gn qualification （DQ） may be performed not only by the instrument developer or manufacturer but also may be performed by the user. The manufacturer 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。 Nonethel