USP1058分析仪器的确认Word文档下载推荐.docx

1、s place in the overall process of obtaining reliable data from analytical instruments.不同于方法学验证和系统适用性试验，分析仪器确认（AIQ）目前并没有明确的指导和规程。关于仪器确认和验证程序，以及执行它们的角色和职责，存在着互相矛盾的观点。由此导致，已有多种方法应用于仪器确认，而这些方法需要使用的资源数量各异并产生数量差异巨大的文件。本节为分析仪器确认（AIQ）提供了科学的方法，并将分析仪器确认（AIQ）作为产生可靠性和一致性数据的重要组成部分。注意，精确应用于确认工序的程度取决于仪器的复杂程度和预期用途。

2、这种方法强调了AIQ从分析仪器中获得可靠数据的全过程中的地位。Validation versus Qualification 验证vs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. Thus, the phrase “analytical instrument qualification” （AI

3、Q） is used for the process of ensuring that an instrument is suitable for its intended application.在本节中，验证一词用于生产工艺、分析方法及软件程序中，而确认一词则用于仪器。因此，“分析仪器的确认”（AIQ）用于确保仪器适用于预期用途的过程。COMPONENTS OF DATA QUALITY 数据质量的组成There are four critical components involved in the generation of reliable and consistent data （

4、quality data）. Figure 1 shows these components as layered activities within a quality triangle. Each layer adds to the overall quality. Analytical instrument qualification forms the base for generating quality data. The other components essential for generating quality data are analytical method val

5、idation, system suitability tests, and quality control check samples. These quality components are described below. 组成可靠和一致数据（质量数据）的有四个关键部分。图1将这些部分展示在质量三角形的层级区域内。每层相加构成了整体质量。分析仪器的确认是产生质量数据的基础。构成质量数据的其他部分为分析方法验证、系统适用性试验和质量控制检验样品。这些质量部分详情如下。Figure 1. Components of data quality.图1.质量数据的组成Analytical Ins

6、trument Qualification 分析仪器的确认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汇总了为确定仪器符合预期用途的文件证明。使用合格的分析仪器能提高生成数据的有效性。Analytical Method

7、 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 quali

8、ty. Additional guidance on validation of compendial procedures may be found in the general information chapter Validation of Compendial Procedures . 分析方法验证汇总了分析过程适用于预期用途的文件证明。使用经确认的分析仪器和验证过的方法所产生的测试数据才可能符合规定。关于药典中验证方法的额外指导可参见通则药典方法的验证。System Suitability Tests 系统适用性试验System suitability tests verify t

9、hat 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 discussion of sys

10、tem suitability tests as related to chromatographic systems.系统适用性试验用于证实该系统符合方法中设定的标准。这些试验连同样品分析一起，确保系统的性能在测试时是适用的。USP通则色谱法呈现了对色谱系统适用性试验更详细的讨论。Quality Control Check Samples 质量控制检查样品Many analysts carry out their tests on instruments standardized using reference materials and/or calibration standards.

11、Some analyses 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 tests. System suitability

12、tests and quality control checks help ensure the quality of analytical results immediately before or during sample analysis.许多分析员用经标准物质和/或校准标准品校准后的仪器进行测试。有些分析员还要求添加质量控制检查样品来保证试验过程中或持续的试验适用性。通过这种方式，AIQ和分析方法验证在测试前提高了分析的质量。系统适用性试验和质量控制检查则在样品分析前或过程中确保了分析结果的质量ANALYTICAL INSTRUMENT QUALIFICATION PROCESS分析

13、仪器确认程序The following sections address in detail the AIQ process. The other three components of building quality into analytical dataanalytical method validation, system suitability tests, and quality control check samplesare not within the scope of this chapter.下面将详述AIQ过程。组成分析数据质量的另三种成分，分析方法验证、系统适用性试

14、验、质量控制检查样品，不在此范围内。Qualification Phases 确认阶段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 （DQ）, installation qualification （IQ）, operational qua

15、lification （OQ）, and performance qualification （PQ）.仪器确认并非一个单独连续的过程，而是若干个独立处理的结果。方便起见，这些处理可分为四个阶段：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

16、 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 and documented. 一些AIQ涵盖多个确认阶段，分析员倾向于进行多个阶段的确认（见表1）。然而，在很多情况下，AIQ有特定顺序要求；比如，必须先进行安装确

17、认才能开始实施其它确认。AIQ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*表1.分析仪器确认每一阶段的时间表、适用性和活动Design Qualification设计确认Installation Qualification安装确认Operational Qualification运行确认Performance Qualification性能确认Timing and Applicability时间表和适用性Prio

18、r to purchase of a new model of instrument购买仪器之前At installation of each instrument （new, old, or existing unqualified）安装仪器时（新的、旧的或一直未经确认的）After installation or major repair of each instrument安装完成后或大修之后Periodically at specified intervals for each instrument仪器在规定间隔内定期进行Activities活动Assurance of manufac

19、turers DQ保证制造商设计确认Description描述Fixed parameters固定参数Preventive maintenance and repairs预防性维护Assurance of adequate support availability from manufacturer保证制造商给予充分支持Instrument delivery仪器运送Establish practices to address operation, calibration, maintenance, and change control建立相关规程用以处理操作、校准、维护及变更控制Instrum

20、ents fitness for use in laboratory仪器在实验室使用的适用性Utilities/facility 公用设施/设备Environment环境Assembly and installation组装与安装Network and data storage网络和数据储存Secure data storage, backup, and archive安全数据储存、备份与存档Installation verificationInstrument function tests仪器性能测试Performance checks性能检查* Activities under each

21、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 activity listed under a given pha

22、se 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. 每个阶段的活动通常按表中所列进行。但在某些情况下，某个活动可能更适合采用另一阶段或者与之结合来进行确认。这些活动横跨不只一个阶段，如表中双箭头所示。

23、如果某个列于给定阶段下的活动在另一阶段中完成，那么就没有必要在列出该活动的阶段重复进行。完成该项活动比该活动处于哪个阶段重要得多。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 selection of the vendor, based on the intended p

24、urpose 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 manufacturer is generally responsible for robust design and maintaining information describing how the analytical instrument is manufac

25、tured （design specifications, functional requirements, etc.） and tested before shipment to users. Nonetheless, the user should ensure that commercial off-the-shelf （COTS） instruments 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 previous interaction with the manufacturer.设计确认（DQ）是基于仪器的预定用途，对仪器的