USP1058分析仪器的确认.docxVIP

分析仪器的确认 (USP39-NF34 Page1055) INTRODUCTIO 介绍 A large variety of laboratory equipme nt, i nstrume nts, 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 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 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. 各种各样的实验室设备、 仪器、计算机化分析系统， 从简单的氮吹仪到复杂的多 功能技术(见 Instrument Categories )，均被用于制药行业，以获得数据来确 保产品达到预期用途。分析的目的是持续获得符合预期目的的可靠的有效数据。 基于实际应用，使用者进行工艺验证、仪器校准，并进行额外的仪器检核，如系 统适用性试验和中间质量控制分析检查样品， 以确保所获得数据的可靠性。 随着 分析仪器的日益复杂化和自动化，对仪器确认的要求也在不断增加。 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 in strume nt qualificati on, approaches that require vary ing amounts of resources and gen erate widely differi ng amounts of docume ntati on. This chapter provides a scie ntific approach to AIQ and con siders AIQ as one of the major comp onents required for gen erat ing reliable and con siste nt data. Note that the amount of rigor applied to the qualification process will depe nd on the complexity and inten ded use of the in strume ntati on. This approach emphasizes AIQs place in the overall process of o