Current through Register Vol. 50, No. 9, September 20, 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 independently checked, reconciled, dated and
signed or initialed by a second. The master production and control record shall
include:
1. [formerly paragraph 6:209-1 (1)]
the name of the product, description of the dosage form and a specimen of the
copy of each label and all other labeling associated with the retail or bulk
unit, including copies of such labeling signed or initialized and dated by the
person or persons responsible for the approval of such labeling;
2. [formerly paragraph 6:209-1 (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 statement of the total weight or
measure of any dosage unit;
3.
a. [formerly paragraph 6:209-1 (3)] a
complete list of ingredients designated by names or codes to indicate any
special quality characteristic;
b.
an accurate statement of the weight or measure of each ingredient, regardless
of whether it appears in the finished product. 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;
c. a
statement of theoretical weight or measure at various stages of processing and
a statement of theoretical yield;
4. [formerly paragraph 6:209-1 (4)] a
description of the containers, closures and packaging and finishing
materials;
5. [formerly paragraph
6:209-1 (5)] manufacturing and control instructions, procedures and
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 one 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. [formerly paragraph 6:209-2 (1)] an
accurate reproduction of the master formula record checked, dated and signed or
initialed by a person responsible for the approval of this record;
2. [formerly paragraph 6:209-2 (2)] a record
of each 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 identification and checking each
significant step in the operation;
3. [formerly paragraph 6: 209-2 (3)] a batch
number that identifies all the production and control documents relating to the
history of the batch and all lot and control numbers associated with the
batch;
4. [formerly paragraph
6:209-2 (4)] a record of any investigation made according to §1533 A
AUTHORITY NOTE:
Promulgated in accordance with the provisions of
R.S.
40:4(A)(1)(a). Also see
R.S. 40:601 et
seq.
