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INTRODUCTION 简介 A large variety of analytical instruments, ranging from a simple apparatus to complex computerized systems, is used in the pharmaceutical industry to acquire data that will help ensure that products meet their specifications. Many of these instruments combine a metrological function with software control. There are many ways of demonstrating that an instrument is qualified and under control, and these can include qualification, calibration, validation, and maintenance. In order to ensure “fitness for purpose”, an integrated approach, based upon a risk assessment, is recommended. For the purposes of this chapter, the term “instrument” includes any apparatus, equipment, instrument, or instrument system used in pharmacopeial analyses. 制药行业使用各种各样的分析仪器，包括简单仪器直至复杂的计算机化系统，以获取有助于确保产品符合其规格标准的数据。其中许多仪器将计量功能与软件控制结合在一起。有多种方法可以证明仪器是合格的并处于控制之下，这些方法包括确认，校准，验证和维护。为确保“适用性”，建议采用基于风险评估的综合方法。就本章而言，术语“仪器”包括用于药典分析的任何装置，设备，仪器或仪器系统。 This informational chapter provides general guidance in a scientific, risk-based approach for carrying out an analytical instrument qualification (AIQ). Detailed instrument operating parameters to be qualified are found in the respective general chapters for specific instrument types. It is left to each laboratory to justify and document its specific approaches. The instrument owners/ users and their management are responsible for assuring their instruments are suitably qualified. 本信息章节为分析仪器确认（AIQ）执行提供了科学的，基于风险方法的通用指导。具体仪器类型的有待确认的详细仪器操作参数可以在相应的通用章节中找到。每个实验室应证明并记录其具体方法。仪器所有者/用户及其管理层有责任确保他们的仪器具经过适当的确认。 This chapter uses various terms, acronyms, and activities common to analytical laboratories and validation disciplines. These terms and activities may not be identical to their usages in all laboratories. The reader is encouraged to be flexible in interpreting the application of these terms and activities in the context and intent of this chapter. 本章使用分析实验室和验证学科常见的各种术语，缩略语和活动。这些术语和活动的使用并不可能与所有实验室中的使用方式相同。鼓励读者在本章的背景和意图下灵活地释义这些术语和活动的应用。 The risk assessment for an AIQ enables the classification of the instrument to determine the extent of qualification and actions needed to demonstrate fitness for purpose. Generally, the more complex the instrument, or the higher the criticality of the measurement, the greater the amount of work that is required to ensure that quality data will be generated. In addition, attention must be paid to ensuring that data integrity and security are maintained. 通过AIQ的风险评估可以对仪器进行分类，从而确定确认和活动的范围程度以证明其适用性。一般来说，仪器越复杂，或者测量的关键性越高，确保生成质量数据所需的工作量就越大。另外，必须注意确保数据完整性和安全性得到维护。 Instruments can generally be classified as belonging to Groups A, B, or C. It should be noted that the same type of instrument can fit into one or more categories, depending on its intended use. 仪器通常可以归类为A，B或C三类。应该注意的是，相同类型的仪器可以适合一个或多个类别 ，这取决于其预期用途。 Group A includes the least complex, standard instruments that are used without measurement capability or user requirement for calibration, such as a magnetic stirrer or vortex mixer. Proper function is ensured by observation, and no further qualification activities are needed for this group. A类包括最不复杂的标准仪器，这些仪器没有测量能力或用户校准需求，例如磁力搅拌器或涡旋混合器。该类仪器仅需通过观察确保适当的功能，并且不需要进一步的确认活动。 Group B includes instruments that may provide a measurement or an experimental condition that can affect a measurement. Examples include a pH meter or an oven. Proper function of instruments in this group may require only routine calibration, maintenance, or performance checks. The extent of activities may depend on the criticality of the application. Generally, these instruments may have firmware but not software that is updated by the user. B类包括提供测量或提供可能会影响测量的实验条件的仪器。例如pH计或烤箱。该类仪器的适当功能可能仅需要例行校准，维护或性能检查。活动的范围和程度可能取决于仪器应用的重要程度。通常，这些仪器可能具有固件，但不包含由用户更新的软件。 Group C comprises analytical instruments with a significant degree of computerization and complexity, such as high-pressure liquid chromatographs and mass spectrometers. All elements of qualification, including software validation, must be considered to ensure proper functioning of instruments in this group. 1S (USP40) C类包含具有高度的计算机化和复杂性的分析仪器，例如高压液相色谱仪和质谱仪。必须考虑所有确认要素，包括软件验证，以确保该类仪器的正常运行。1S (USP40) 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 (quality data). Figure 1 shows these components as layered activities within a quality triangle. Each layer adds to the overall quality. AIQ 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 check samples. These quality components are described below. 产生可靠和一致性数据（质量数据）包括四个关键要素。图1用质量三角形的分层形式描述了这些组成部分。每一层都在总体质量中。分析仪器确认组成了获得质量数据的基础。其他产生质量数据的必要的组成部分包括分析方法验证，系统适用性试验，质量控制检查样品。这些质量组成部分描述如下： Figure 1. Components of data quality. 图1. 数据质量的组成
Analytical Instrument 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是收集文件化证据证明仪器的使用符合其预期用途。在分析中，使用已确认的仪器有助于提高对生成数据有效性的信任度。
Analytical 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 quality. Additional guidance on validation of compendial procedures may be found in Validation of Compendial Procedures 1225>. 分析方法验证是收集文件化证据证明分析程序适用于预期用途。在确认过的仪器上运行验证过的分析程序进行检测，所产生的产品合格检测数据将值得信赖。在药典程序验证〈1225〉中可以找到关于药典程序验证的附加指导。
System Suitability Tests 系统适用性实验 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 system's performance is acceptable at the time of the test. Chromatography <621>presents a more detailed discussion of system suitability tests related to chromatographic systems. 系统适用性试验证明系统将根据程序中规定的标准执行。这些试验与样品分析一起进行，以保证在检测时系统的性能是可接受的。与色谱系统有关的系统适用性试验在色谱分析〈621〉章节中有更详细的讨论。
Quality Control Check Samples 质量控制检查样品 Many analysts carry out their tests on instruments that have been standardized by1S (USP40) using reference materials and/or calibration standards. Some analyses also require the inclusion of quality control check samples to provide an in-process or ongoing assurance of the test'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. 许多分析员已经使用对照品和/或校准标准标准化的1S (USP40)仪器上进行测试。一些分析还要求加入质量控制检查样本，以对测试的适当性能提供过程或持续保证。以这种方式，AIQ和分析方法验证有助于在分析人员进行测试之前提高分析质量。系统适用性试验和质量控制检查有助于确保样品分析前或样品分析过程中分析结果的质量。 |
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