Current through Register Vol. 54, No. 44, November 2, 2024
(a) To
assure uniformity from batch to batch, a master production and control record
for each drug product and each batch size of drug product shall be prepared,
dated, and signed or initialed by a competent and responsible individual and
shall be independently checked, reconciled, dated and signed by a second
competent and responsible individual. The master production and control record
shall include:
(1) The name of the product,
description, of the dosage form, and a specimen or copy of each label and all
other labeling associated with the retail or bulk unit, including copies of
such labeling signed or initialed and dated by the person or persons
responsible for approval of such labeling.
(2) The name and weight or measure of each
active ingredient per dosage unit or per unit of weight or measure of the
finished drug, and a statement of the total weight or measure of any dosage
unit.
(3) A complete list of
ingredients designated by names or codes sufficiently specific to indicate any
special quality characteristic; and accurate statement of the weight or measure
of each ingredient regardless of whether it appears in the finished product,
except that reasonable variations may be permitted in the amount of components
necessary in the preparation in dosage form provided that provisions for such
variations are included in the master production and control record; an
appropriate statement concerning any calculated excess of an ingredient; an
appropriate statement of theoretical weight or measure at various stages of
processing; and a statement of the theoretical yield.
(4) A description of the containers,
closures, and packaging and finishing materials.
(5) Manufacturing and control instructions,
procedures, specifications, special notations, and precautions to be
followed.
(b) The batch
production and control record shall be prepared for each batch of drug produced
and shall include complete information relating to the production and control
of each batch. These records shall be retained for at least two years after the
batch distribution is complete or at least 1 year after the batch expiration
date, whichever is longer. These records shall identify the specific labeling
and lot or control numbers used on the batch and shall be readily available
during such retention period. The batch record shall include:
(1) An accurate reproduction of the
appropriate master formula record checked, dated, and signed or initialed by a
competent and responsible individual.
(2) A record of each significant step in the
manufacturing, processing, packaging, labeling, testing, and controlling of the
batch, including dates, individual major equipment and lines employed; specific
identification of each batch of components used; weights and measures of
components and products used in the course of processing; in-process and
laboratory control results; and identifications of the individuals actively
performing and the individuals directly supervising or checking each
significant step in the operation.
(3) A batch number that identifies all the
production and control documents relating to the history of the batch and all
lot or control numbers associated with the batch.
(4) A record of any investigation made
according to §
25.16(8)
(relating to production and control procedures).
