请参见ICH指南.
Batch (or Lot):
A specific quantity of material produced in a process or series of processes so that it is expected to be homogeneous within specified limits. In the case of continuous production, a batch may correspond to a defined fraction of the production. The batch size can be defined either by a fixed quantity or by the amount produced in a fixed time interval.
批:
由一个或一系列工艺过程生产的一定数量的物料,因此在规定的限度内是均一的。在连续生产中,一批可能对应于与生产的某一特定部分。其批量可规定为一个固定数量,或在固定时间间隔内生产的数量。