摘要
探讨原料药生产中混匀批号的生产日期确定办法。上一个混匀批的尾料(即:零头)混入下一批,尾料按照ICH指南的Q3A(R)的指导原则中控制杂质的标准来控制,确认混入商业批的尾料在混匀批中<0.1%时,可忽略。用尾料和生产批中最早的生产批次的生产日期定为混匀批的生产日期。
Identify the manufacturing date of APIs blended.The tail material of last batch blended with the next batch,control the tail material with ICH Q3A（R） guide lines which controls impurities;when the tail ma＇terial is less than 0.1% of the commercial batch,it can be iguored.The manufacture date of blended tail material and production batch is determined by the earliest production batch manufacturing date.
