Kan. Admin. Regs. § 28-21-262 - Master production and control records
Batch production and control records.
(1) To assure uniformity from batch to batch,
a master production and control record for each drug product and each batch
size of amygdalin (laetrile) shall be prepared, dated, and signed or initialed
by a competent and responsible individual and shall be independently checked,
reconciled, dated, and signed or initialed by a second competent and
responsible individual. The master production and control record shall include:
(A) 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.
(B) The name and
weight or measure of each active ingredient per dosage unit or per unit of
weight or measure of the finished product and a statement of the total weight
or measure of any dosage unit.
(C)
A complete list of ingredients designated by names or codes sufficiently
specific to indicate any special quality characteristic; an 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.
(D) A description of the
containers, closures, and packaging and finishing materials.
(E) Manufacturing and control instructions,
procedures, specifications, special notations, and precautions to be followed.
(2) The batch
production and control record shall be prepared for each batch of amygdalin
(laetrile) produced and shall include complete information relating to the
production and control of each batch. These records shall be retained for at
least two (2) years after the batch distribution is complete, or at least one
(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:
(A) An accurate
reproduction of the appropriate master formula checked, dated, and signed or
initialed by a competent and responsible individual.
(B) 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 individual(s) actively
performing and the individual(s) directly supervising or checking each
significant step in the operation.
(C) A batch number that identified all the
production and control documents relating to the history of the batch and all
lot or control numbers associated with the batch.
(D) A record of any investigation made.
Notes
State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and the prior quarterly release. More comparison features will be added as we have more versions to compare.
No prior version found.