【作者】 吕巧莉； 王艳春； 谢纳泽； 孙建勋；

【Author】 Lv Qiaoli;Wang Yanchun;Xie Naze;Sun Jianxun;College of Pharmacy,Henan University;

【机构】 河南大学药学院；

【摘要】 目的:通过对格列吡嗪片工艺参数进行评估,确定其质量风险管理的关键控制点(CCP)并建立HACCP工作计划,按照HACCP计划进行生产从而消除和降低格列吡嗪片整个生产过程的质量风险。方法:运用危害分析及关键控制点(HACCP)法对2013—2014年洛阳新春都生物制药有限公司生产的22批格列吡嗪片进行分析。结果和结论:按照针对格列吡嗪片的生产情况进行一系列的质量风险评估所制定的HACCP计划在格列吡嗪片生产实施可将风险降低和消除,有效控制产品质量。更多还原

【Abstract】 Object:The technology parameters of glipizide tablets is evaluated to determine the critical control points(CCP) of quality of risk management and to estabUsh the HACCP work schedule,according to which,the glipizide tablets quality risk in the whole production process can be eliminated and reduced.Methods:The method of hazard analysis and critical control point(HACCP) is applied to analyze the production of 22 batches of glipizide tablets in Luoyang XinChunDu Bio-Pharm.Co.,LTD.from 2013 to 2014.Results and Conclusion:By using the HACCP work schedule based on a series of risk assessments in quality of the production of glipizide tablets,the implementation risk of glipizide tablets production can be reduced and eliminated,and the product quality can be effectively controlled.更多还原