Cal. Code Regs. Tit. 4, § 17216 - Batch Production Record
(a)
A licensed manufacturer shall prepare a written batch production record every
time a batch of a cannabis product is manufactured or a batch of cannabis or
cannabis product is remediated. The batch production record shall accurately
follow the appropriate master manufacturing protocol, and each step of the
protocol shall be performed in the production of the batch.
(b) The batch production record shall
document all the following information about each batch at the time the batch
is produced or remediated:
(1) The licensee
number or premises address of the facility at which the production
occurred;
(2) The date each step of
the master manufacturing protocol was performed and the initials of the
employee performing each step;
(3)
The identity and weight or measure of each component used in production of the
batch;
(4) The specific equipment
and processing lines used in producing or remediating the batch;
(5) A statement of the actual yield and the
percentage difference from expected yield at appropriate phases of
manufacturing as identified in the master manufacturing protocol;
(6) If the product quality plan identifies
any monitoring needed to ensure product safety, the results of the monitoring
action performed;
(7) An actual or
representative label or other identification of the label to be used for the
cannabis product;
(8) The actual
quantity of the packages and labels used, and the difference from the expected
quantity to be used, if the cannabis product will leave the manufacturing
premises as a final form cannabis good;
(9) Documentation that quality control
personnel:
(A) Reviewed the batch production
record;
(B) Reviewed all required
monitoring operation(s); and
(C)
Either approved and released, or rejected, the finished cannabis product,
including any remediated, repackaged or relabeled cannabis
product;
(10)
Documentation, at the time of performance, of any investigation identified in
the product quality plan or master manufacturing protocol, including deviations
from the expected yield or package and label count; and
(11) The UID and the batch or lot number of
the finished batch of cannabis product and the UIDs of all cannabis or cannabis
products used in the batch.
(c) The batch production record shall:
(1) Contain the actual values and
observations obtained during monitoring and, as appropriate, during
verification activities;
(2) Be
accurate, indelible, and legible;
(3) Be created concurrently with performance
of the activity documented; and
(4)
Be as detailed as necessary to provide a history of work
performed.
Notes
2. New section refiled 3-28-2022 as an emergency; operative 3-28-2022 (Register 2022, No. 13). This filing is a deemed emergency pursuant to Business and Professions Code sections 26013(b)(3) and 26153.1(k). A Certificate of Compliance must be transmitted to OAL by 9-26-2022 or emergency language will be repealed by operation of law on the following day.
3. Certificate of Compliance as to 3-28-2022 order, including amendment of section and NOTE, transmitted to OAL 9-26-2022 and filed 11-7-2022; amendments effective 11-7-2022 pursuant to Government Code section 11343.4(b)(3) (Register 2022, No. 45).
Note: Authority cited: Sections 26013 and 26130, Business and Professions Code. Reference: Sections 26011.5 and 26039.6, Business and Professions Code.
2. New section refiled 3-28-2022 as an emergency; operative
3. Certificate of Compliance as to 3-28-2022 order, including amendment of section and Note, transmitted to OAL 9-26-2022 and filed 11/7/2022; amendments effective
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