过程分析技术在药品生产过程中的应用
Application of process analysis technology in pharmaceutical production process
分类号：R917
出版年·卷·期（页码）：2018,38 (5):748-757
DOI:
10.16155/j.0254-1793.2017.01.01
-----摘要：-------------------------------------------------------------------------------------------
首先阐述过程分析技术（process analysis technology，PAT）的概念并探讨了其与实时放行（real time release，RTR）、质量源于设计（quality by design，QbD）、设计空间（design space，DS）及质量风险管理（quality risk management，QRM）的关系；其次概述了PAT研究应用的工具并重点综述近红外光谱（near infrared spectroscopy，NIR）技术在化学药品及中药实际生产过程的应用；最后总结了PAT存在的问题及其应用前景。
-----英文摘要：---------------------------------------------------------------------------------------
This paper introduces the concept of process analysis technology (PAT), and discusses its relationship with real time release (RTR),quality by design (QbD),design space (DS) and quality risk management (QRM). And then the technology involved in PAT is summarized,and the application of near infrared spectroscopy (NIR) in the actual production process of chemicals and traditional Chinese medicine is mainly reviewed.Finally,the existing problems and application prospects of PAT are summarized.
-----参考文献：---------------------------------------------------------------------------------------
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