Medicated feed CGMPs (Part 225) and type A medicated article CGMPs (Part 226) - combining discrete batches into a commingled lot
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.
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.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
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