(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.
Credits
Note: Authority cited: Sections 26013 and 26130, Business and Professions Code. Reference: Sections 26011.5 and 26039.6, Business and Professions Code.
History
1. New section filed 9-27-2021 as an emergency; operative 9-27-2021 (Register 2021, No. 40). 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 3-28-2022 or emergency language will be repealed by operation of law on the following day.
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).
This database is current through 4/26/24 Register 2024, No. 17.
