初步危害分析(PHA):制药行业风险分析的重要方法

Soniya Kundnani, Dhara Patel, Dhananjay Meshram
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摘要

初步危害分析(PHA)是一种半定量的评价,用于识别系统的早期布局和定义级别,所有可能导致事故的潜在危害和危险事件,根据其严重程度对已识别的危险事件进行分类,并确定所需的危害控制和相应的后续行动。它是一个很好的工具,开始认识到一个系统的危害。在某些情况下,分析一个简单的系统只需要一个PHA。这也是对更复杂系统进行危害分析的第一步。这篇综述说明了PHA在分析维护过程/程序中的应用,讨论了设计不良可能造成的伤害,并提出了解决方案。
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Preliminary Hazard Analysis (PHA): Great approach to risk analysis in pharmaceutical industry
Preliminary Hazard Analysis (PHA) is a semi-quantitative evaluation executed to recognize, early within side the layout and definition level of a system, all potential hazards and hazardous events that can cause an accident, classify identified hazardous events according to their severity and identify the required hazard controls and their respective follow-up actions. It is a great tool for beginning to recognize the hazards of a system. In some cases, a PHA is all that is needed to analyse a simple system. It is also the first step in the hazard analysis of more complicated systems. This review illustrates PHA's use for analysing a maintenance process/procedure and discusses the injuries that can occur with poor design and recommend solutions.
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