目的 阐述过程分析技术(PAT)提出的背景和意义,对PAT内容进行归纳,并综述近年来PAT在制药领域的应用、研究进展及对我国制药行业的启示。方法 查阅国内外近年来文献,进行归纳总结。结果与结论 PAT促进对生产过程和药品的理解,提高对药品生产效率,强化对药品质量的控制,是未来制药行业生产的发展方向。我国制药行业需加强对PAT的理解,将其融入生产过程,从药品质量的源头抓起,提高药品质量。随着研究的深入和重视程度的提高,制药行业将从现有的传统生产模式向一个具有前瞻性的PAT生产模式转变。
关键词
药品生产质量管理规范 /
过程分析技术 /
过程控制 /
过程理解 /
应用
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参考文献
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