多品种原料药生产线更换生产品种的质量风险评估

Assessment of Quality Risk in Multi-products Production Line while Changing Product

对多品种原料药生产线更换生产品种时存在的质量风险进行识别、分析、评估、控制、降低、接受、沟通直至关闭,达到从源头上确保多品种原料药生产线能最大限度地降低污染、交叉污染、混淆和差错的风险的目的。

The quality risk existed in multi-products production line while changing products was identified, analyzed and accessed. The risk should be controlled and reduced to the level which can be accepted, or else after being communicated, the line should be closed so that the risks of contamination, cross contamination, confusion and errors can be reduced to lowest extension from the origin of the line.