中国药房Issue(25)：3460-3463,4.DOI:10.6039/j.issn.1001-0408.2015.25.02
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
Application Evaluation of Hazard Analysis and Critical Control Point System in Wet Granulation and Tableting Technology
于泳 1顾家慧 1崔文波 2方芳 3沈启雯4
作者信息
- 1. 东南大学成贤学院，南京 210088
- 2. 上海市食品药品监督管理局，上海 200439
- 3. 南京医药中等专业学校，南京 211100
- 4. 中国药科大学国际医药商学院，南京210009
- 折叠
摘要
Abstract
OBJECTIVE:To evaluate the feasibility and effectiveness of Hazard analysis and critical control point (HACCP) system in the process of production of Loratadine tablets. METHODS:Taking wet granulation and tableting technology of Lorata-dine tablets as an example,and through the introduction of the concept of HACCP,the basic theory and method of HACCP were applied for hazard analysis on each production link to find critical control points and set critical limits for production quality man-agement. RESULTS:By HACCP analysis,three links namely drying,granules fitting and mixing,internal and external packaging were finally determined as the critical control points in the process of production of Loratadine tablets,thereby critical control lim-its were set for monitoring. After effective control over the risks in the process was ensured,HACCP work plan was made and veri-fied,and the results showed that HACCP system could effectively control and reduce the risks in the process of production and en-sure quality safety. CONCLUSIONS:Application of HACCP system to wet granulation and tableting technology of Loratadine tab-lets can fully embody its feasibility and effectiveness.关键词
危害分析/关键控制点/湿法制粒压片工艺/质量控制/药品生产质量管理规范/氯雷他定片Key words
Hazard analysis/Critical control point/Wet granulation and tableting technology/Quality control/Good manufac-turing practices/Loratadine tablets分类
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于泳,顾家慧,崔文波,方芳,沈启雯..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[J].中国药房,2015,(25):3460-3463,4.
