基于固体制剂生产工艺的质量风险管理研究

Study on Quality Risk Management Based on the Production Process of Solid Preparation

目的:降低固体制剂生产工艺中的质量风险,确保产品质量。方法:在分析固体制剂生产工艺的基础上,运用质量风险管理工具(失败模式和效果评价,FMEA)对固体制剂生产工艺包含的基本操作单元中存在的质量风险进行风险评估、风险控制及风险审核,并对固体制剂生产工艺提出改进完善建议。结果与结论:在固体制剂生产工艺中,混合操作单元中的混合时间、制软材操作单元中的黏合剂用量和黏合剂加入速度以及干燥操作单元中的干燥温度均属于高风险影响因素。建议可通过建立标准操作规程、实施参数及中间体控制、进行生产工艺验证以及开展定期风险评估来改进固体制剂生产工艺,以确保产品质量。

OBJECTIVE：To reduce quality risk of the solid preparation production process,and to ensure the quality of the product. METHODS：On the basis of analysis of solid preparation production process,the quality risk management tool（failure mode and effect analysis,FMEA）was used to take risk assessment,risk control and risk review in the basic production unit of solid preparation. Then suggestions were put forward for the improvement of solid preparation production process. RESULTS CONCLUSIONS：In solid preparation production process,the mixing time of mixing operation unit,the mount of adhesives and adhesives joining speed of soft material preparation unit,and drying temperature of drying operation unit are high risk factors. It＇s suggested that the production process of solid preparation can be improved by establishing standard operational procedures,controlling parameters and intermediates,taking production process validation and carrying out regular risk assessment.