HACCP在口服固体制剂包衣工艺中的应用

摘要

Objective:To use risk management tool for the risk management of oral solid drug. Methods:HACCP was adopted to analyze the hazard of the coating process for enteric coated tablets, conifrm critical control points and monitoring procedure and compare the situation of quality before and after implementation of HACCP. Results:The release rate and the appearance quality of the product A were obviously improved and the quality risk was reduced when HACCP was implemented. Conclusion:HACCP is an effective risk management tool to estimate hazard and establish the control system.%　　目的：运用风险管理工具进行口服固体制剂风险管理。方法：采用HACCP对肠溶片包衣工艺进行危害分析，确定关键控制点和监控程序，比较实施前后质量情况。结果：实施HACCP后，A产品释放度和外观质量明显改善，降低了质量风险。结论：HACCP是一种有效的评估危害和建立控制体系的风险管理工具。