化学原料药生产过程中质量风险管理研究  

Research on Quality Risk Management in the Production Process of Chemical Raw Materials

作　　者：周宝祥 胡杰 曹清 ZHOU Baoxiang;HU Jie;CAO Qing

机构地区：[1]浙江手心制药有限公司,浙江杭州311227

出　　处：《化工设计通讯》2024年第11期158-160,共3页Chemical Engineering Design Communications

摘　　要：本研究通过精心设计的实验,深入探究了化学原料药生产过程中质量风险管理的关键环节。实验数据揭示,生产参数对关键质量指标的影响显著,进而影响着产品的安全性和生产效率。现有质量风险管理策略虽有一定效果,但在某些条件下仍存在局限性。不仅展示实验数据的统计结果和变化趋势,还深入分析潜在风险,并提出针对性的风险控制方法和技术,这些发现对于优化化学原料药生产过程、提升产品质量具有重要的理论和实践意义。This study delves into the key aspects of quality risk management in the production process of chemical raw materials through carefully designed experiments.Experimental data reveals that production parameters have a significant impact on key quality indicators,which in turn affect product safety and production efficiency.Although existing quality risk management strategies have some effectiveness,they still have limitations under certain conditions.This article not only presents the statistical results and trends of experimental data,but also deeply analyzes potential risks and proposes targeted risk control methods and technologies.Thesefindings have important theoretical and practical significance for optimizing the production process of chemical raw materials and improving product quality.

关 键 词：化学原料药 质量风险管理 生产参数 风险控制 

分 类 号：TQ460.7[化学工程—制药化工]