2.3 Batch 批

defined quantity of raw material, packaging material or product issued from one process or series of processes so that it could be expected to be homogeneous

从某个或多个操作获得的、认为是一致的特定数量的原料，包材或产品。

2.4 batch number 批号

distinctive combination of numbers, letters and/or symbols, which specifically identifies a batch

单个数字，字母，或字母和数字结合的，用来指定识别一批产品的代码.

2.5bulk produc 散装产品

any product which has completed manufacturing stages up to, but not including, final packaging

经过所有制造工艺过程的产品，除了没有填充到独立包装的产品。

2.6Calibration 校准

set of operations that establish, under specified conditions, the relationship between values indicated by a measuring

instrument or measuring system, or values represented by a material measure, and the corresponding known values of a reference standard

在特定条件下，通过一系列操作在测量仪器或测量系统所指示的量值，或事物量具或参考事物表示的值，和按标准实现的相应值间建立起一种关系。

2.7 change control 变更控制

internal organization and responsibilities relative to any planned change of one or several activities covered by the Good Manufacturing Practices in order to ensure that all the manufactured, packaged, controlled and stored products correspond to the defined acceptance criteria

为确保生产，包装，控制，储存符合接收标准，组织所作的内部机构、职责与 GMP 内容有关的任何计划的变动。