Application Evaluation of Hazard Analysis and Critical Control Point System in Wet Granulation and Tableting Technology
10.6039/j.issn.1001-0408.2015.25.02
- VernacularTitle: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
- Author:
Yong YU
;
Jiahui GU
;
Wenbo CUI
;
Fang FANG
;
Qiwen SHEN
- Publication Type:Journal Article
- Keywords:
Hazard analysis;
Critical control point;
Wet granulation and tableting technology;
Quality control;
Good manufac-turing practices;
Loratadine tablets
- From:
China Pharmacy
2015;(25):3460-3463
- CountryChina
- Language:Chinese
-
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.
