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Sec. 680.400 Medicated feeds -- Combined Batches (CPG 7126.37)
Medicated feed CGMPs (Part 225) and type A medicated article CGMPs (Part 226) -
combining discrete batches into a commingled lot
BACKGROUND:
A number of manufacturers of type A medicated articles and medicated feeds produce
discrete batches in batch mixers which are subsequently combined in a holding bin from
which packaging occurs. The batches in the holding bin are often unit packaged to fill a
single customer or packaging order. Although the product in the holding bin is not
uniformly mixed as a unit, it is assigned a single lot number. The reason for this
procedure is to permit efficient production practices and to facilitate unit packaging.
POLICY:
A single lot number may be assigned to commingled batches as described above provided
the production and distribution records afford an identifiable history back to the
individual batch records. If an individual batch or any portion of the commingled lot is
out of potency specification or otherwise adulterated, the entire commingled lot will be
considered adulterated.
Since the mixer batches are not subsequently mixed as a unit under this procedure,
there is no assurance that samples from the holding bin are representative of the
contents. Therefore, the sampling and assay schedules in the CGMPs are to be applied to
the individual mixer batches, and not to the commingled lot.
As part of its internal quality control, the manufacturer should determine that
ingredient segregation does not occur in the holding bins during the packaging process.
This may be done by sampling and assaying periodically under an
appropriately designed procedure, i.e., at appropriate intervals during packaging until
the bin is empty.
Issued: 3/1/82
Revised: 6/1/86