Manufacturing Processes Procedures
Manufacturing Processes Procedures. – §40250. Manufacturing Processes and Procedures.
(a) The licensee shall implement and maintain manufacturing processes and procedures that ensure cannabis product quality. Manufacturing processes and procedures shall be identified through a product quality plan, as described in Section 40253. (b) The licensee shall maintain written master manufacturing protocols, as described in Section 40255, for each unique formulation of cannabis product manufactured to ensure only intended components are included and that the cannabis product is packaged and labeled in accordance with product specifications and these regulations. (c) The licensee shall maintain written batch production records, as described in Section 40258, to document the production process and, if needed, to verify that the established processes and procedures, including the preventive measures and master manufacturing protocol, were implemented correctly. (d) All manufacturing records are subject to inspection by the Department, its inspectors and agents. Authority: Sections 26012; 26013; and 26130, Business and Professions Code. Reference: Sections 26011.5; and 26131, Business and Professions Code.
§40253. Product Quality Plan (a) The licensee shall create 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, could cause the product to be adulterated or misbranded, or could cause the product to fail laboratory or quality assurance testing. (b) To create the product quality plan, the licensee shall conduct a comprehensive assessment of the overall manufacturing process, identifying each step from component intake through transfer of product from the premises, to determine the potential risks associated with each step, the preventive measures to mitigate the potential risks identified, the methods to evaluate and monitor the effectiveness of the preventive measures, and action to take if a preventive measure was unsuccessful. (c) The product quality plan shall evaluate the following potential risks to cannabis product quality: (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. (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 product quality plan shall identify the preventive measure that will be implemented 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; (4) Implementing procedures to ensure proper homogeneity of cannabinoids into a cannabis product to mitigate against the risk of a non-homogeneous product; (e) The product quality plan shall identify 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 undesirable pathogens; (4) Monitoring the temperature of raw materials that need to be held below 41 F to prevent microbial contamination; (f) The product quality plan shall identify actions to be taken if the evaluation and monitoring of the preventive measure indicates that the 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 that may be taken include, but are not limited to: (1) Destruction of product components or finished product; (2) Further processing of cannabis extract to remove impurities;
(3) Reworking the unfinished product to further homogenize the cannabinoids; (g) The licensee 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 licensee may consider the product quality plan subject to trade secret protection. Authority: Sections 26012; 26013; and 26130, Business and Professions Code. Reference: Sections 26011.5; and 26131, Business and Professions Code.