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BUREAU OF CANNABIS CONTROL § 5506 Microbusiness Records for Licensees Engaging in Manufacturing Activities

§ 5506 Microbusiness Records for Licensees Engaging in Manufacturing Activities

(a) In addition to the records required by section 5037 of this division, a microbusiness engaging
in manufacturing activities shall maintain batch production records.
(b) The licensee shall prepare a written batch production record every time a batch of cannabis is
manufactured. The batch production record shall accurately follow the appropriate
manufacturing protocol, and each step of the protocol shall be performed in the production of the
batch.
(c) The batch production record shall document complete information relating to the production
and control of each batch, including all of the following details:
(1) The batch or lot number of the finished batch of cannabis product of all cannabis products
used in the batch;
(2) The identity of equipment and processing lines used in producing the batch;
(3) The date and time of the maintenance, cleaning, and sanitizing of the equipment and
processing lines used in producing the batch, or a cross-reference to records, such as individual
equipment logs, where this information is retained;
(4) The identification number assigned to each component (or, when applicable, to a cannabis
product received from a supplier for packaging or labeling as a cannabis product), packaging,
and label used;
(5) The identity and weight or measure of each component used;
(6) A statement of the actual yield and a statement of the percentage of theoretical yield at
appropriate phases of processing;
(7) The actual results obtained during any monitoring operation;
(8) The results of any testing or examination performed during the batch production, or a crossreference to such results; and
(9) Documentation, at the time of performance, of the manufacture of the batch, including:
(A) The date on which each step of the manufacturing protocol was performed; and
(B) The initials of the persons performing each step, including:
(i) The initials of the person responsible for weighing or measuring each component used in the
batch;
(ii) The initials of the person responsible for verifying the weight or measure of each component
used in the batch;
(iii) The initials of the person responsible for adding the component to the batch; and
(iv) The initials of the person responsible for verifying the addition of components to the batch.
(10) Documentation, at the time of performance, of packaging and labeling operations,
including:
(A) An actual or representative label, or a cross-reference to the physical location of the actual or
representative label specified in the manufacturing record;
(B) The expected number of packaging and labels to be used, the actual quantity of the
packaging and labels used, and, when label reconciliation is required, reconciliation of any
discrepancies between issuance and use of labels; and
(C) The results of any tests or examinations conducted on packaged and labeled cannabis
products (including repackaged or relabeled cannabis products), or a cross-reference to the
physical location of such results.
(11) Documentation at the time of performance that quality control personnel have:
(A) Reviewed the batch production record;
(B) Reviewed all monitoring operation(s) required in section 40264 of title 17 of the California
Code of Regulations;
(C) Reviewed the results of all tests and examinations, including tests and examinations
conducted on components, in-process materials, finished batches of cannabis product, and
packaged and labeled cannabis products;
(D) Either approved and released–or rejected–the batch for distribution; and
(E) Either approved and released–or rejected– the finished cannabis product, including any
repackaged or relabeled cannabis product.
(12) Documentation at the time of performance of any required material review and disposition
decision.
(d) 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;
(4) Be as detailed as necessary to provide history of work performed; and:
(A) Include information adequate to identify any associated manufacturing facility (e.g., the
name, license number, and when necessary, the location of the facility);
(B) Include the date and, when appropriate, the time of the activity documented;
(C) Include the signature or initials of the person performing the activity; and
(D) Where appropriate, include the identity of the product and the lot number or batch identifier,
if any.
Authority: Section 26013, Business and Professions Code. Reference: Sections 26013 and
26160, Business and Professions Code.

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