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Implementing PAT for pharmaceutical processes

机译:实施PAT进行药物过程

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Process Analytical Technology (PAT) includes all tools that can be used for analysing and controlling manufacturing through timely measurements (i.e., during processing) of critical quality and performance attributes of raw and in-process materials and processes with the goal of ensuring final product quality. The aim of the presentation is to show practical examples of the implementation of PAT to increase process understanding and efficiency on an industrial scale. The tools for process understanding and control are mainly based on multivariate data acquisition and analysis methods, and modern spectroscopic process analysers. These tools provide a scientific risk-based approach to justify how real time quality assurance may be equivalent to, or better than, laboratory-based testing on collected samples.
机译:过程分析技术(PAT)包括所有工具,可用于通过及时测量(即,在处理期间)的临界质量和性能属性的临界质量和性能属性以及用于确保最终产品质量的过程的临界质量和性能属性来分析和控制制造。介绍的目的是表明执行实施实际示例,以提高工业规模的过程理解和效率。用于过程理解和控制的工具主要基于多变量数据采集和分析方法,以及现代光谱过程分析仪。这些工具提供了一种基于科学的风险的方法,以证明实时质量保证如何相当于或优于基于实验室的样本的测试。

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