危害分析和关键控制点体系在湿法制粒压片工艺中的应用评价

发布时间：2018-03-05 12:44

本文选题：危害分析　切入点：关键控制点　出处：《中国药房》2015年25期 　论文类型：期刊论文

【摘要】：目的:评价危害分析和关键控制点(HACCP)体系在氯雷他定片生产过程中应用的可行性和有效性。方法:通过介绍HACCP的概念,并以氯雷他定片的湿法制粒压片工艺为例,应用HACCP的基本理论与方法对其各生产环节进行危害分析,找出关键控制点并建立关键限值,进行生产质量管理。结果:经HACCP分析,最终确定干燥、整粒与混合、内外包装3个环节为氯雷他定片生产过程中的关键控制点,并据此设定关键控制限值进行监控,在确保对工艺过程的风险进行有效控制后建立HACCP工作计划并进行验证,结果显示,HACCP体系能有效控制与降低其生产过程中的风险,确保其质量安全。结论:将HACCP体系运用于氯雷他定片湿法制粒压片工艺,可以较为完整地体现其在该工艺中应用的可行性与有效性。
[Abstract]:Objective: To evaluate the hazard analysis and critical control point (HACCP) system in the feasibility of the application of Loratadine Tablets in the production process and effectiveness. Methods: through the introduction of the concept of HACCP, and the wet granulation tabletting process Loratadine Tablets as an example, the basic theory and method of application of HACCP hazard analysis of the production process, find out the key control and establish critical limits for production quality management. Results: by HACCP analysis, and ultimately determine the whole grain drying and mixing, and packaging as 3 critical control points in the production process of Loratadine Tablets, and then set the key control limits for monitoring, effective control to ensure the process after the establishment of risk HACCP work plan and verify the results show that HACCP system can effectively control and reduce the risk in the process of the production, ensure the quality and safety. Conclusion: the HACCP system use Loratadine Tablets in the wet granulation process, can be fully reflected in the process of its feasibility and effectiveness.

【作者单位】：东南大学成贤学院;上海市食品药品监督管理局;南京医药中等专业学校;中国药科大学国际医药商学院;
【分类号】：R95

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