USP 1058 分析仪器的确认.docx

USP1058 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 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 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 users 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 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 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 AIQ 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 AIQ’s place in the overall process of ob