The glossary in Q7A defines “batch” as “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”. In API manufacturing, it is common to process material coming from one reactor through
various centrifuge loads because of capacity limitations of the equipment, or various drying loads
because of the same reason. This is still considered one batch. They are sub-batches of the
same material coming from one reactor. When these sub-batches are brought back together, this
is considered a mixing operation. If portions of different batches are combined, this is considered
blending.
