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§ 17215. Master Manufacturing Protocol.

4 CA ADC § 17215Barclays Official California Code of RegulationsEffective: November 7, 2022

Barclays California Code of Regulations
Title 4. Business Regulations
Division 19. Department of Cannabis Control
Chapter 8. Manufacturers
Article 4. Good Manufacturing Practices
Effective: November 7, 2022
4 CCR § 17215
§ 17215. Master Manufacturing Protocol.
Currentness
(a) A licensed manufacturer shall establish and follow a written master manufacturing protocol for each unique formulation of cannabis product manufactured, and for each batch size, in order to mitigate the potential for adulteration through incorporation of incorrect amounts of cannabinoids, unintended ingredients, or hazards identified in the product quality plan; the potential for misbranding through incorporation of ingredients not identified on the label or mislabeling of the product; and to ensure uniformity in finished batches and across all batches produced.
(b) The master manufacturing protocol shall include:
(1) The name and intended cannabinoid concentration(s) of the cannabis product to be manufactured;
(2) A complete list of components to be used;
(3) The weight or measure of each component to be used. The master manufacturing protocol for any given product may include the ability to adjust the weight or measure of cannabinoid-containing ingredients in order to account for the variability of cannabinoid content in harvest batches;
(4) The identity and weight or measure of each ingredient that will be declared on the ingredients list of the cannabis product;
(5) The expected yield of the finished cannabis product, based upon the quantity of components or packaging to be used in the absence of any loss or error in actual production, and the maximum and minimum percentages of expected yield beyond which a deviation investigation of a batch will be necessary, material review will be conducted, and a decision on the disposition of the product will be made;
(6) A description of packaging and a representative label, or a cross-reference to the physical location of the actual or representative label;
(7) The expected number of packages and labels to be used, if the cannabis product will leave the manufacturing premises in final form and packaged and labeled as it will be sold at retail;
(8) Written instructions for each point, step, or stage in the manufacturing process; and
(9) Written instructions for any action to mitigate risk(s) identified in the product quality plan.
(c) Master manufacturing protocols shall be in writing and made available to the Department upon request.
(d) Nothing in this chapter requires disclosure of the master manufacturing protocol to any person other than the individuals conducting activities that utilize the protocol or to the Department and its inspectors and agents. The licensee may consider the master manufacturing protocol subject to trade secret protection.

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 subsections (b)(5) and (b)(7) and amendment of 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.
Cal. Admin. Code tit. 4, § 17215, 4 CA ADC § 17215
End of Document