(1997; 248 pages) [French]
2.3 Quantities of material
Batch: “a quantity of any drug produced during a given cycle of manufacture.”1
1 As defined in Good Practices in the Manufacture and Quality Control of Drugs (WHO Official Records, No. 226, 1975, p. 88).
If the manufacturing process is continuous, the batch originates in a defined period of time during which the manufacturing conditions have not been modified.
Consignment: quantity of a bulk starting material, or of a drug product, made by one manufacturer that is supplied at one time in response to a particular request or order. A consignment may comprise one or more packages or containers and may include material belonging to more than one batch.
Sampling unit: discrete part of a consignment, such as an individual package, drum or container.