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§ 17214. Product Quality Plan.

4 CA ADC § 17214Barclays 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 § 17214
§ 17214. Product Quality Plan.
Currentness
(a) A licensed manufacturer shall establish and implement a written product quality plan for each type of product manufactured at the premises. The product quality plan shall address the hazards associated with the premises or the manufacturing process that, if not properly mitigated, may cause the product to be adulterated or misbranded, or may cause the product to fail laboratory testing or quality assurance review.
(b) To create the product quality plan, the licensed manufacturer shall conduct a comprehensive assessment of the overall manufacturing process, as follows:
(1) Identify each step from component intake through transfer of product from the premises;
(2) Evaluate the potential risks associated with each step;
(3) Identify the preventive measures that shall be taken to mitigate the potential risks identified;
(4) Identify the methods to evaluate and monitor the effectiveness of the preventive measures; and
(5) Identify any action to take if a preventive measure was unsuccessful.
(c) The licensed manufacturer shall evaluate the following potential risks to cannabis product quality that could be introduced during manufacturing operations:
(1) Biological hazards, including microbiological hazards;
(2) Chemical hazards, including radiological hazards, pesticide contamination, solvent or other residue, natural toxins, decomposition, or allergens;
(3) Physical hazards, such as stone, glass, metal fragments, hair, or insects; and
(4) Process failures that may lead to product contamination, allergen cross-contact, packaging errors, labeling errors, or other errors affecting cannabis product quality.
(d) The licensed manufacturer shall identify and implement the preventive measure(s) necessary to mitigate each potential risk identified pursuant to subsection (c). Examples of preventive measures include, but are not limited to:
(1) Cleaning and sanitizing of equipment and utensils to mitigate against risk of microbiological hazards;
(2) Conducting in-house testing of raw cannabis to mitigate against the risk of pesticide contamination;
(3) Establishing an allergen control program to ensure that allergen cross-contact does not occur between product types; and
(4) Implementing procedures to ensure homogeneity of cannabinoids into a cannabis product to mitigate against the risk of a non-homogeneous product.
(e) The licensed manufacturer shall identify and implement methods to evaluate and monitor the effectiveness of the preventive measures in mitigating the potential risks identified in subsection (c). Methods for evaluation and monitoring of preventive measures include, but are not limited to, the following:
(1) Review of test results conducted to determine contamination such as pesticide residue;
(2) Maintaining and reviewing cleaning, sanitizing, or maintenance logs to verify such actions have been taken;
(3) Conducting environmental testing to determine if equipment or utensils are contaminated with pathogens; and
(4) Monitoring the temperature of raw materials that need to be held below 41 degrees Fahrenheit to prevent microbial contamination.
(f) The licensed manufacturer shall identify actions to be taken if the evaluation and monitoring of the preventive measure indicates that a risk was not properly mitigated. The corrective action shall be specific to the type of product under evaluation and the specific risk to be mitigated. Examples of corrective actions include, but are not limited to:
(1) Destruction of product components or finished cannabis product;
(2) Further manufacturing of cannabis extract to remove impurities; and
(3) Reworking the unfinished product to further homogenize the cannabinoids.
(g) The licensed manufacturer shall maintain the product quality plans and documentation of preventive measures, monitoring results, and corrective actions and make the records available to the Department upon the Department's request, including during the Department's onsite inspection of the premises. Nothing in this chapter requires the disclosure of product quality plans other than to the Department and its inspectors and agents. The licensed manufacturer may consider the product quality plan 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 of subsection (g) 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.
Cal. Admin. Code tit. 4, § 17214, 4 CA ADC § 17214
End of Document