所有您需要知道的无菌检测设备验证。

IF 5.4 2区 医学 Q1 MICROBIOLOGY
Journal of Clinical Microbiology Pub Date : 2025-09-10 Epub Date: 2025-08-11 DOI:10.1128/jcm.01477-24
James E T Gebo, Kayla M Feehely, Chase E Lattimore, Dylan P Mogavero, Anna F Lau
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引用次数: 0

摘要

由于先进治疗方法的快速发展,产品无菌检测要求在临床微生物实验室变得越来越普遍。大多数实验室主任对进行此类测试犹豫不决,因为它们属于由美国食品和药物管理局(FDA)监管的现行良好生产规范(cGMP),其期望与临床要求(由医疗保险和医疗补助服务中心监管)不同。当考虑在临床实验室进行cGMP测试时,大多数焦点放在分析测试验证上。在这篇小型综述中,我们概述了cGMP质量体系中的一个关键要素,即通过安装、操作和性能确认(IQ、OQ、PQ或IOPQ)对设备、软件和系统进行验证。这个术语在临床实验室中并不常见,并且IQ和OQ部分经常被忽视,没有执行,和/或没有记录,尽管存在阶段II CAP要求(COM.30550和COM.30575)。这篇小型综述将概述IOPQ框架,包括什么以及它与CAP要求的不同之处,IOPQ的重要考虑因素,以及与设备验证相关的FDA引用摘要。我们提供了使用血液培养系统的例子,控制温度单位(ctu;例如,培养箱)和实验室信息管理系统,考虑到它们在临床实验室cGMP活动中使用的可能性。重要的是,这里总结的IOPQ要求也与2025年3月31日裁决撤销之前归类为“器械”的实验室开发测试(ldt)相关。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

All you need to know about equipment validation for sterility testing.

All you need to know about equipment validation for sterility testing.

All you need to know about equipment validation for sterility testing.

Product sterility testing requests are becoming increasingly common in clinical microbiology laboratories due to the rapid development of advanced therapies. Most laboratory directors are hesitant to bring on such tests because they fall under current Good Manufacturing Practices (cGMP) regulated by the United States Food and Drug Administration (FDA), where expectations differ from clinical requirements (regulated by the Centers for Medicare and Medicaid Services). When considerations are made for cGMP testing in the clinical lab, most focus is placed on analytical test validation. In this mini-review, we provide an overview of one critical element within the cGMP quality system-validation of equipment, software, and systems through installation, operational, and performance qualification (IQ, OQ, and PQ or IOPQ). This terminology is not common in clinical laboratories, and the IQ and OQ portions are often overlooked, not performed, and/or not documented, although phase II CAP requirements exist (COM.30550 and COM.30575). This mini-review will provide an overview of the IOPQ framework, what is included and how it differs from CAP requirements, important considerations for an IOPQ, and a summary of FDA citations relating to equipment validation. We provide examples using blood culture systems, controlled temperature units (CTUs; e.g., incubator), and the laboratory information management system, given their likelihood for use in cGMP activities in the clinical lab. Importantly, the IOPQ requirements summarized here would have also been relevant to laboratory-developed tests (LDTs) classified as "devices" prior to the March 31, 2025, annulment of the ruling.

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来源期刊
Journal of Clinical Microbiology
Journal of Clinical Microbiology 医学-微生物学
CiteScore
17.10
自引率
4.30%
发文量
347
审稿时长
3 months
期刊介绍: The Journal of Clinical Microbiology® disseminates the latest research concerning the laboratory diagnosis of human and animal infections, along with the laboratory's role in epidemiology and the management of infectious diseases.
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