ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Batch

A defined quantity of starting material, packaging material or product processed in one process or series of processes so that it could be expected to be homogeneous.

Publication Source: Rules and Guidance for Pharmaceutical Manufacturers and Distributors. Medicines Control Agency (MCA)

See also: Lot

Batch

(IEEE) Pertaining to a system or mode of operation in which inputs are collected and processed all at one time, rather than being processed as they arrive, and a job, once started, proceeds to completion without additional input or user interaction.

Publication Source: FDA Glossary of Computerized System and Software Development Technology

Contrast with:

Batch

(ICH Q7) 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 lot. The batch size can be defined either by a fixed quantity or by the amount produced in a fixed time interval.

Publication Source: ISPE Baseline® Guide, Vol. 6: Biopharmaceutical Manufacturing Facilities

Publication Date: 2004

See also: Lot

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