质量风险管理在药品固体制剂车间的应用

Application of Quality Risk Management in the Pharmaceutical Solid Preparation Workshop

目的:降低在药品固体制剂车间多品种共线生产中的质量风险,确保产品质量。方法:根据药品固体制剂生产的主要操作工序大致相同的特点,运用质量风险管理的方法和工具,建立药品固体制剂车间的质量风险管理模型。结果与结论:通过对固体制剂车间多品种共用厂房、设施、设备生产中可能存在的风险进行评估,对风险高的环节采取有效的控制措施,使多品种共线生产所产生的质量风险降低到可以接受的水平,保证药品质量。

Objective： To reduce the quality risk of different products produced on the same line in the pharmaceutical solid preparation workshop, and to ensure the quality of the products. Methods： Based on the fact that the pharmaceutical solid preparations have the similar main operation processes, the quality risk management model of pharmaceutical solid preparation workshop was established using the methods and tools of quality risk management. Results and Conclusion： According to the evaluation of the possible risks of the common buildings, facilities and production equipment used to produce different products in the solid preparation workshop, effective measures were taken to control the risks and to decrease the quality risk arising from the collinear production to an acceptable level so as to ensure the quality of drugs.