Batch and Batch Number


A defined quantity of starting material, packaging material or finished pharmaceutical product processed in a single process or series of processes so that it is expected to be homogeneous.

It may sometimes be necessary to divide a batch into a number of sub-batches, which are later brought together to form a final homogeneous batch.

In the case of terminal sterilization, the batch size is determined by the capacity of the autoclave. In continuous manufacture, the batch must correspond to a defined fraction of the production, characterized by its intended homogeneity.

The batch size can be defined either as a fixed quantity or as the amount produced in a fixed time interval.

Batch Number (or Lot Number)

A unique combination of numbers, letters, and/or symbols that identifies a batch (or lot) and from
which the production and distribution history can be determined.

Related Topics:

Data IntegrityBiotechnologyBioinformatics

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