浅析在中药注射剂生产企业中建立危害分析和关键控制点管理体系

摘要

OBJECTIVE: To improve the quality of TCM injection, and to avoid the occurrence of adverse event for poor quality of TCM injection. METHODS: Taking production technology of TCM injection of final sterilization small capacity as example, the principle and process of hazard analysis and critical control point (HACCP) management system were introduced. RE-SULTS&CONCLUSION: The quality of TCM injection can be improved by hazard analysis of production process of TCM injection, finding out critical control point, determining the critical limits, setting up monitoring system and corrective action, ensuring the effective implementation of HACCP system.%目的:提高中药注射剂质量,避免因中药注射剂质量不合格引起的药害事件的发生.方法:以最终灭菌小容量中药注射剂的生产工艺为例,介绍危害分析和关键控制点(HACCP)管理体系的原理和步骤.结果与结论:对中药注射剂的生产过程进行危害分析,找出关键控制点,确定关键限值,建立监测体系和纠偏措施,保证HACCP管理体系的有效实施,可提高中药注射剂的质量.