质量风险管理在药物口服固体制剂生产中的应用  

Application of Quality Risk Management in the Production of Oral Solid Pharmaceutical Preparations

作　　者：梁伟连 LIANG Weilian(Guangzhou Baiyunshan Mingxing Pharmaceutical Co.,Ltd.,Guangzhou 510220,China)

机构地区：[1]广州白云山明兴制药有限公司,广东广州510220

出　　处：《山东化工》2025年第4期208-210,共3页Shandong Chemical Industry

摘　　要：药物口服固体制剂是一个市场较为广阔的药物类型,而且作为我国临床药物开发的主要种类之一,各方面的开发、市场流程都是有效关注的重点。质量风险管理主要包括对生产环节的风险评估、风险管控,以及针对性质量检测、管理,是一项综合性的工作内容。以提升药物口服固体制剂生产质量风险管理水平为目标,相关企业不能够忽略市场实际的需求与药品生产情况,建立更加合理的质量风险管理流程。从质量风险管理优化方面深入,分析质量风险管理对药物口服固体制剂生产,讨论质量风险管理的关键点,总结管理优化的方向,并提出建议以供参考。Oral solid drug preparation is a relatively broad market of drug types,and as one of the main types of clinical drug development in our country,the development of various aspects of the market process are the focus of effective attention.Quality risk management mainly includes risk assessment,risk control of production links,as well as targeted quality testing and management,which is a comprehensive work content.Withe the gool of improving the quality risk management level of oral solid drug preparation,relevant enterprises can not ignore the actual market demand and drug production situation,and establish a more reasonable quality risk management process.From the aspect of quality risk management optimization,this paper analyzes the impact of quality risk management on the production of oral solid drug preparations,discusses the key points of quality risk management,summarizes the direction of management optimization,and puts forward suggestions for reference.

关 键 词：质量管理 风险管理 口服药物 固体制剂生产 

分 类 号：TQ460[化学工程—制药化工]