A Risk Assessment and Risk Based Approach Review of Pre-use/Post Sterilization Integrity Testing (PUPSIT).

Q3 Medicine
Kelly Waldron, Amanda McFarland, Hal Baseman, Maik Jornitz
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引用次数: 0

Abstract

In January 2023, ICHQ9 was updated to include expanded guidance on risk-based decision-making, emphasizing its application in informing science-driven and strategic decisions. The revised guidance highlights that while quality risk management can aid decision-making, it does not eliminate the industry's obligation to comply with regulatory requirements. This article introduces a framework for evaluating the risks and benefits of pre-use/post-sterilization integrity testing (PUPSIT) using risk management principles. It provides a structured approach to assess the acceptability of alternative methods to the EU Annex 1 PUPSIT requirement, which acknowledges that PUPSIT may not always be feasible due to constraints such as the filtration of small solution volumes. In such cases, Annex 1 permits alternative approaches if a comprehensive risk assessment is conducted and effective controls are implemented to mitigate the risk of non-integral filtration systems. The proposed framework considers three critical domainspatient safety, process integrity, and regulatory complianceto ensure decisions are well-informed and balanced. By applying this science- and risk-based approach, organizations can navigate PUPSIT requirements effectively, ensuring compliance while addressing operational limitations.

消毒前/消毒后完整性检测(PUPSIT)的风险评估和基于风险的方法综述。
2023年1月,ICHQ9进行了更新,扩大了对基于风险的决策的指导,强调了其在科学驱动和战略决策中的应用。修订后的指南强调,虽然质量风险管理可以帮助决策,但它并没有消除行业遵守监管要求的义务。本文介绍了一个使用风险管理原则评估使用前/灭菌后完整性测试(PUPSIT)的风险和收益的框架。它提供了一种结构化的方法来评估欧盟附件1 PUPSIT要求的替代方法的可接受性,其中承认由于过滤小溶液体积等限制,PUPSIT可能并不总是可行的。在这种情况下,如果进行了全面的风险评估并实施了有效的控制以减轻非整体过滤系统的风险,则附录1允许采用替代方法。提议的框架考虑了三个关键领域——患者安全、流程完整性和法规遵从性,以确保决策是充分了解和平衡的。通过应用这种基于科学和风险的方法,组织可以有效地驾驭PUPSIT需求,在解决操作限制的同时确保遵从性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
1.90
自引率
0.00%
发文量
34
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