§17207. Manufacturing Practices Definitions.
In addition to the definitions in section 26001 of the Act and section 15000 of this division, the following definitions shall govern the construction of this chapter:
(a)“Allergen cross-contact” means the unintentional incorporation of a food allergen into a cannabis product.
(b) “Component” means any substance or item intended for use in the manufacture of a cannabis product, including those substances or items that are not intended to appear in the finished cannabis product. “Component” includes cannabis, cannabis products used as ingredients, raw materials, other ingredients, and processing aids.
(c) “Contact surface” means any surface that contacts cannabis products and cannabis product components and those surfaces from which drainage, or other transfer, onto the cannabis product or cannabis product components, occurs during the normal course of operations. Examples of contact surfaces include containers, utensils, tables, and equipment.
(d) “Easily cleanable” means a characteristic of a surface that allows effective removal of soil, food residue, or other organic or inorganic materials by normal cleaning methods.
(e) “Environmental pathogen” means a pathogen capable of surviving and persisting within the manufacturing environment such that cannabis products may be contaminated and may result in illness if consumed or used without treatment to significantly minimize the environmental pathogen. Examples of environmental pathogens include Listeria monocytogenes and Salmonella spp. but do not include the spores of pathogenic spore- forming bacteria.
(f) “Hazard” means any biological, chemical, radiological, or physical agent that has the potential to cause illness or injury.
(g) “Holding” means storage of cannabis or cannabis products and includes activities performed incidental to storage of a cannabis product and activities performed as a practical necessity for the distribution of that cannabis product.
(h) “Microorganisms” means yeasts, molds, bacteria, viruses, protozoa, and microscopic parasites and includes species that are pathogens. The term “undesirable microorganisms” includes those microorganisms that are pathogens, that subject a cannabis product to decomposition, that indicate that a cannabis product is contaminated with filth, or that otherwise may cause a cannabis product to be adulterated.
(i) “Monitor” means to conduct a planned sequence of observations or measurements to assess whether preventive measures are operating as intended.
(j) “Pathogen” means a microorganism that can cause illness or injury.
(k) “Potable” means water that meets the requirements of Health and Safety Code section 113869.
(l) “Preventive measures” means those risk-based, reasonably appropriate procedures, practices, and processes that a person knowledgeable about the safe manufacturing, processing, packing, or holding of food would employ to significantly minimize or prevent the hazards identified pursuant to a product quality plan as specified in section 17214.
(m) “Processing aid” means any substance that is added to a cannabis product during manufacture but is removed in some manner from the cannabis product before it is packaged in its finished form. This includes substances that are converted into constituents normally present in the product, and do not significantly increase the amount of the constituent naturally found in the product. This also includes substances that are added to a product for their technical or functional effect in the processing but are present in the finished product at insignificant levels and do not have any technical or functional effect in that product.
(n) “Qualified individual” means a person who has the education, training, or experience (or a combination thereof) necessary to manufacture quality cannabis products as appropriate to the individual’s assigned duties. A qualified individual may be, but is not required to be, an employee of the licensed manufacturer.
(o) “Quality control” means a planned and systematic operation or procedure for ensuring the quality of a cannabis product.
(p) “Quality control operation” means a planned and systematic procedure for taking all actions necessary to prevent cannabis product(s) from being adulterated or misbranded.
(q) “Quality control personnel” means any person, persons, or group designated by the licensed manufacturer to be responsible for quality control operations.
(r) “Raw material” means any unprocessed material in its raw or natural state that is intended to become part of the components of a cannabis product.
(s) “Sanitize” means to treat cleaned surfaces by a process that is effective in destroying vegetative cells of pathogens and substantially reducing numbers of other undesirable microorganisms, but without adversely affecting the product or its safety for the consumer.
(t) “Smooth” means any of the following:
- A contact surface that is free of pits, pinholes, cracks, crevices, inclusions, rough edges, and other surface imperfections detectable by visual or tactile inspection.
- A floor, wall, or ceiling having an even or level surface with no roughness or projections that render it difficult to clean.
(u) “Utensil” means an implement, tool, or container used in the storage, preparation, manufacture, or processing of cannabis and cannabis products. In addition to kitchenware, examples of utensils include, but are not limited to, gloves, screens, sieves, implements to create pre-rolls, buckets, and scissors.
(v) “Validate” means obtaining and evaluating scientific and technical evidence that a control measure, combination of control measures, or set of quality control procedures, when properly implemented, is capable of ensuring the quality of a cannabis product or effectively controlling an identified hazard.
(w) “Verification” means the application of methods, procedures, tests, or other evaluations, in addition to monitoring, to determine whether a control measure or combination of control measures is or has been operating as intended and to establish the validity of the quality control procedures.
(x) “Yield” means the quantity of a particular cannabis product expected to be produced at a given step of manufacture or packaging, as identified in the master manufacturing protocol. The expected yield is based upon the quantity of components or packaging to be used, in the absence of any loss or error in actual production. “Actual yield” means the quantity of a particular cannabis product that is actually produced at a given step of manufacture or packaging that is recorded in the batch production record.
Authority cited: Sections 26013 and 26130, Business and Professions Code.
Reference: Sections 26001 and 26130, Business and Professions Code.
§17208. Quality Control Program.
(a) A licensed manufacturer shall establish and implement a quality control program to ensure that cannabis products are not adulterated or misbranded. The quality control program shall describe how the licensee will comply with the following:
- Grounds, building, and manufacturing premises standards, as specified in section 17209;
- Equipment and utensil requirements, as specified in section 17210;
- Personnel procedures, as specified in section 17211;
- Cannabis product component procedures, as specified in section 17212; and
- Manufacturing processes and procedures, as specified in section 17213.
(b) The quality control program shall be under the supervision of one or more qualified individuals assigned responsibility for this function.
(c) For purposes of this article, for those requirements that are contained in the Health and Safety Code, use of the term “food” shall include cannabis, cannabis products, components, and contact surfaces.
Authority cited: Sections 26013 and 26130, Business and Professions Code.
Reference: Sections 26011.5 and 26039.6, Business and Professions Code.
§17209. Grounds, Building, and Manufacturing Premises.
(a) Exterior facility and grounds. A licensed manufacturer shall ensure the facility exterior and grounds under the licensed manufacturer’s control meet the following minimum standards:
- Grounds shall be equipped with draining areas in order to prevent pooled or standing water;
- Weeds, grass, and vegetation shall be cut within the immediate vicinity of the cannabis manufacturing premises, litter and waste shall be removed, and equipment shall be stored in order to minimize the potential for the grounds to constitute an attractant, breeding place, or harborage for pests;
- Roads, yards, and parking lots shall be maintained so that these areas do not constitute a source of contamination in areas where cannabis products are handled or transported;
- Openings into the building (such as windows, exhaust fans, ventilation ducts, or plumbing vent pipes) shall be screened, sealed, or otherwise protected to minimize potential for pests to enter the building;
- Waste treatment and disposal systems shall be provided and maintained so as to prevent contamination in areas where cannabis products may be exposed to such a system’s waste or waste by-products.
- A licensed manufacturer shall implement precautions within the premises, such as inspection or extermination, if the premises is bordered by grounds outside the licensed manufacturer’s control that are not maintained in the manner described in subsections (1) through (5), in order to eliminate any pests, dirt, and filth that pose a source of cannabis product contamination. Any use of insecticide, rodenticide, or other pesticide within the premises shall meet the requirements of Health and Safety Code section 114254.
(b) Interior facility. A licensed manufacturer shall ensure construction, design, and maintenance of the interior of the manufacturing premises as follows:
- Walls, ceilings, and floors. Walls, ceilings, and floors shall be constructed of material that is smooth, nonporous, easily cleanable, corrosion-resistant, and suitable to the activity that will be conducted. Fixtures, ducts, and pipes shall not pose a source of drip or condensate that may contaminate cannabis, cannabis products, components, contact surfaces, or packaging material.
- Lighting. Interior facility lighting shall meet the requirements of the Health and Safety Code section 114252, subdivisions (a)(1) and (3), (b)(3) and (4), and (c). Interior facility lighting shall also meet the requirements for shatter-resistant lighting in Health and Safety Code section 114252.1. The requirements of Health and Safety Code section 114252.1(a), shall also apply to all areas where glass breakage may result in the contamination of exposed cannabis, cannabis products, components, contact surfaces, or packaging material.
- Plumbing system and fixtures.
- Water supply. Running water shall be supplied as required by Health and Safety Code section 114192 in all areas where required for the manufacturing of cannabis products; in all areas used for the cleaning of equipment, utensils, and packaging materials; and for employee sanitary facilities. Water that contacts cannabis, cannabis products, components, contact surfaces, or packaging materials shall be potable.
- Plumbing. Plumbing systems shall meet the requirements of Health and Safety Code section 114190.
- Sewage disposal. The sewage system shall be maintained and kept in good repair so that it does not pose a potential source of contamination of cannabis, cannabis products, components, contact surfaces, or packaging materials.
- Toilet facilities. A licensed manufacturer shall provide employees with access to toilet facilities that meet the requirements of Health and Safety Code section 114250. Toilet facilities shall be kept clean and shall not pose a potential source of contamination of cannabis, components, cannabis products, contact surfaces, or packaging materials.
- Hand-washing facilities. A licensed manufacturer shall provide hand-washing facilities that meet the requirements of Health and Safety Code sections 113953(a)-(d) and 113953.2.
- Waste disposal. A licensed manufacturer shall provide for waste disposal in accordance with Health and Safety Code sections 114244(a) and (c) and 114245.1. Cannabis waste shall be disposed of in accordance with section 17223.
- Ventilation. Ventilation systems shall meet the requirements of Health and Safety Code sections 114149 and 114149.3.
- Cleaning and maintenance. The premises, including any fixtures, and other physical facilities therein, shall be maintained in a clean and sanitary condition and kept in good repair so as to prevent cannabis products from becoming adulterated, and shall meet the requirements of Health and Safety Code section 114257.1.
- The premises shall have a janitorial facility that meets the requirements of Health and Safety Code section 114279(a).
- Cleaning equipment and supplies shall be stored in a manner that meets the requirements of Health and Safety Code section 114281.
- Poisonous or toxic materials such as cleaning compounds, sanitizing agents, and pesticide chemicals that are necessary for premises and equipment maintenance and operation shall be handled and stored in a manner that meets the requirements of Health and Safety Code sections 114254.1, 114254.2 and 114254.3.
Authority: Sections 26013 and 26130, Business and Professions Code.
Reference: Sections 26011.5 and 26039.6, Business and Professions Code.
§17210. Equipment and Utensils.
(a) Design and construction. Equipment and utensils shall meet the requirements of Health and Safety Code sections 114130.1, 114130.2, 114130.3, and 114130.4 and shall be used in accordance with their operating instructions to avoid the adulteration of cannabis products with lubricants, fuel, metal fragments, contaminated water, or any other contaminants.
(b) Installation. Equipment shall be installed so as to allow cleaning and maintenance of the equipment and of adjacent spaces. Equipment that is not easily moveable shall meet the requirements of Health and Safety Code section 114169.
(c) Cleaning, sanitizing, and maintenance. Equipment and utensils shall be maintained in a clean and sanitary condition and kept in good repair. The quality control program for cleaning, sanitizing, and maintenance of equipment and utensils shall include the following elements, at minimum:
- A detailed, written procedure for cleaning, sanitizing, and maintaining (including calibrating) equipment and utensils;
- A schedule for cleaning, sanitizing, and maintaining equipment and utensils;
- A log for documentation of the date and time of maintenance, cleaning, and sanitizing of equipment and utensils; and
- A procedure for storing cleaned and sanitized equipment and utensils in a manner to protect the equipment and utensils from contamination.
Authority: Sections 26013 and 26130, Business and Professions Code.
Reference: Sections 26011.5 and 26039.6, Business and Professions Code.
§17211. Manufacturing Personnel.
(a) Licensed manufacturers shall establish and implement procedures for personnel that include, at minimum:
- Disease control. Any individual who by medical examination or supervisory observation is shown to have, or appears to have, an illness specified in Health and Safety Code section 113949.2(a) or an open lesion (e.g., boil, sore, cut, rash, or infected wound), unless covered in accordance with the requirements of Health and Safety Code section 113949.2(b), shall be excluded from any manufacturing operations until their health condition is corrected. Personnel shall be instructed to report such health conditions to their supervisors.
- Cleanliness. All individuals working in direct contact with cannabis, cannabis products, components, contact surfaces, and packaging materials shall maintain personal cleanliness in order to protect against allergen cross-contact and contamination of cannabis products while on duty. The methods for maintaining personal cleanliness include:
- Wearing clean outer clothing to protect against allergen cross-contact and contamination of cannabis, cannabis products, components, contact surfaces, and packaging materials;
- Washing hands thoroughly in a hand-washing facility that meets the requirements of section 17209 before starting work, after each absence from a work station, at any time specified in Health and Safety Code section 113953.3, and at any time when the hands may have become soiled or contaminated;
- Removing all unsecured jewelry and other objects that might fall into cannabis, cannabis products, components, equipment, or containers. Hand jewelry that cannot be sanitized shall be removed during periods in which cannabis products are manipulated by hand. If such hand jewelry cannot be removed, it shall be covered by material that can be maintained in an intact, clean, and sanitary condition and that effectively protects against contamination by these objects of cannabis, cannabis products, components, contact surfaces, and packaging materials;
- Maintaining gloves used in cannabis product handling in an intact, clean, and sanitary condition;
- Wearing hair nets, caps, beard covers, or other hair restraints that are designed and worn to prevent hair contact with cannabis, cannabis products, components, contact surfaces, and packaging materials;
- Storing clothing and personal belongings in areas separate from those where cannabis products are exposed or where equipment or utensils are washed; and
- Confining the following activities to areas separate from those where cannabis products may be exposed or where equipment or utensils are washed: eating food, chewing gum, drinking beverages, and using tobacco.
(b) Nothing in this section prohibits a licensed manufacturer from establishing additional precautions to protect against allergen cross-contact and contamination of cannabis, cannabis products, components, contact surfaces, and packaging materials by microorganisms or foreign substances (e.g., perspiration, hair, cosmetics, tobacco, chemicals, and medicines applied to the skin).
(c) The procedures for manufacturing personnel shall be in writing and made available to the Department upon request.
Authority: Sections 26013 and 26130, Business and Professions Code.
Reference: Sections 26011.5 and 26039.6, Business and Professions Code.
§17211.1. Training Program.
(a) A manufacturing licensee shall establish and implement a training program to ensure that all personnel present at the premises are provided information and training that, at minimum, covers the following topics:
- Within 30 days of the start of employment:
- Health and safety hazards;
- Hazards presented by all solvents or chemicals used at the licensed premises as described in the safety data sheet for each solvent or chemical;
- Emergency response procedures;
- Security procedures;
- Record keeping requirements; and
- Training requirements.
- Prior to independently engaging in any cannabis manufacturing process:
- An overview of the cannabis manufacturing process and standard operating procedure(s);
- Quality control procedures;
- Product quality plans developed in accordance with section 17214;
- Proper and safe usage of equipment or machinery;
- Safe work practices applicable to an employee’s job tasks, including appropriate use of any necessary safety or sanitary equipment;
- Cleaning and maintenance requirements;
- Emergency operations, including shutdown; and
- Any additional information reasonably related to an employee’s job duties.
- Additionally, a manufacturing licensee that produces edible cannabis products shall ensure that all personnel who prepare, handle, or package edible products successfully complete a California food handler certificate course from an entity accredited by the American National Standards Institute (ANSI) within 90 days of commencing employment at the premises and again every three years during employment. A manufacturing licensee shall obtain documentation evidencing the fulfillment of this requirement;
(b) A manufacturing licensee shall ensure that all personnel receive annual refresher training to cover, at minimum, the topics listed in subsection (a). This annual refresher training must be completed within 12 months of the previous training completion date.
(c) A manufacturing licensee shall maintain a record of training containing, at minimum:
- A list of all personnel at the premises including, at minimum, name and job duties of each individual;
- Documentation of training topics and dates of training completion, including refresher training, for all personnel;
- The signatures of each individual and the licensee verifying receipt and understanding of each training or refresher training completed by the individual; and
- Any official documentation attesting to the successful completion of required training by personnel.
(d) A manufacturing licensee may assign responsibility for the training of individual personnel to supervisory personnel. Assigned supervisory personnel must have the education, training, or experience (or a combination thereof) necessary to ensure the production of quality cannabis products by all personnel. The assigned training personnel shall sign and date a document on an annual basis attesting that they received and understands all information that will be provided to personnel in the training program. This documentation shall be maintained as part of the record requirements in subsection (c).
Authority: Sections 26013 and 26130, Business and Professions Code.
Reference: Sections 26011.5, 26130 and 26160, Business and Professions Code.
§17212. Cannabis Product Components.
(a) In order to prevent adulteration of cannabis products, licensed manufacturers shall establish and implement written policies and procedures to ensure and maintain the quality of product components.
(b) Components are subject to the following minimum requirements:
- Components that are food must be obtained from a source that complies with federal and state food laws.
- Raw materials and other components shall be inspected upon intake to ensure that they are clean and suitable for manufacturing into cannabis products, and shall be stored under conditions that protect against allergen cross-contact and contamination and minimize deterioration.
- Raw materials shall be washed or cleaned as necessary to remove soil and other visible contaminants. Water used for washing, rinsing, or conveying cannabis product ingredients shall be potable.
- Raw materials and other components shall not contain levels of microorganisms that render the cannabis product injurious to human health, or shall be pasteurized or otherwise treated during manufacturing so that they no longer contain levels of microorganisms that would cause the cannabis product to be adulterated.
- Raw materials and other components susceptible to contamination with aflatoxin or other natural toxins, pests, or extraneous material shall not exceed generally acceptable limits set by the U.S. Food and Drug Administration in the Defect Levels Handbook (Rev. February 2005), which is hereby incorporated by reference, before these raw materials or other ingredients are incorporated into cannabis products.
- Raw materials and other components shall be held in containers designed and constructed to protect against allergen cross-contact or contamination, and shall be held at a temperature and relative humidity and in a manner that prevents the cannabis products from becoming adulterated.
- Frozen raw materials and other components shall be kept frozen. If thawing is required prior to use, it shall be done in a manner that prevents the raw materials and other ingredients from becoming adulterated.
- Raw materials and other components that are food allergens shall be identified and held in a manner that prevents cross-contact with other raw materials or ingredients.
(c) Holding and storage of raw materials and other components shall meet the requirements of Health and Safety Code sections 114047(a) and (b), 114049, and 114051.
(d) The policies and procedures for components shall be in writing and made available to the Department upon request.
Authority: Sections 26013 and 26130, Business and Professions Code.
Reference: Sections 26011.5 and 26039.6, Business and Professions Code.
§17213. Manufacturing Procedures.
(a) A licensed manufacturer shall implement and maintain the following manufacturing procedures that ensure cannabis product quality:
- A product quality plan, as described in section 17214;
- Master manufacturing protocols, as described in section 17215, 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 this division; and
- Batch production records, as described in section 17216, to document the production process and, if needed, to verify that the established procedures, including the preventive measures and master manufacturing protocol, were implemented correctly.
(b) All manufacturing records and procedures shall be in writing and are subject to inspection by the Department, its inspectors and agents.
Authority: Sections 26013 and 26130, Business and Professions Code.
Reference: Sections 26011.5 and 26039.6, Business and Professions Code.
§17214. Product Quality Plan.
(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:
- Identify each step from component intake through transfer of product from the premises;
- Evaluate the potential risks associated with each step;
- Identify the preventive measures that shall be taken to mitigate the potential risks identified;
- Identify the methods to evaluate and monitor the effectiveness of the preventive measures; and
- 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:
- Biological hazards, including microbiological hazards;
- Chemical hazards, including radiological hazards, pesticide contamination, solvent or other residue, natural toxins, decomposition, or allergens;
- Physical hazards, such as stone, glass, metal fragments, hair, or insects; and
- 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:
- Cleaning and sanitizing of equipment and utensils to mitigate against risk of microbiological hazards;
- Conducting in-house testing of raw cannabis to mitigate against the risk of pesticide contamination;
- Establishing an allergen control program to ensure that allergen cross-contact does not occur between product types; and
- 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:
- Review of test results conducted to determine contamination such as pesticide residue;
- Maintaining and reviewing cleaning, sanitizing, or maintenance logs to verify such actions have been taken;
- Conducting environmental testing to determine if equipment or utensils are contaminated with pathogens; and
- 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:
- Destruction of product components or finished cannabis product;
- Further manufacturing of cannabis extract to remove impurities; and
- 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.
Authority: Sections 26013 and 26130, Business and Professions Code.
Reference: Sections 26011.5 and 26039.6, Business and Professions Code.
§17215. Master Manufacturing Protocol.
(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:
- The name and intended cannabinoid concentration(s) of the cannabis product to be manufactured;
- A complete list of components to be used;
- 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;
- The identity and weight or measure of each ingredient that will be declared on the ingredients list of the cannabis product;
- 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;
- A description of packaging and a representative label, or a cross-reference to the physical location of the actual or representative label;
- 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;
- Written instructions for each point, step, or stage in the manufacturing process; and
- 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.
Authority: Sections 26013 and 26130, Business and Professions Code.
Reference: Sections 26011.5 and 26039.6, Business and Professions Code.
§17216. Batch Production Record.
(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:
- The licensee number or premises address of the facility at which the production occurred;
- The date each step of the master manufacturing protocol was performed and the initials of the employee performing each step;
- The identity and weight or measure of each component used in production of the batch;
- The specific equipment and processing lines used in producing or remediating the batch;
- 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;
- If the product quality plan identifies any monitoring needed to ensure product safety, the results of the monitoring action performed;
- An actual or representative label or other identification of the label to be used for the cannabis product;
- 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;
- Documentation that quality control personnel:
- Reviewed the batch production record;
- Reviewed all required monitoring operation(s); and
- Either approved and released, or rejected, the finished cannabis product, including any remediated, repackaged or relabeled cannabis product;
- 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
- 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:
- Contain the actual values and observations obtained during monitoring and, as appropriate, during verification activities;
- Be accurate, indelible, and legible;
- Be created concurrently with performance of the activity documented; and
- Be as detailed as necessary to provide a history of work performed.
Authority: Sections 26013 and 26130, Business and Professions Code.
Reference: Sections 26011.5 and 26039.6, Business and Professions Code.
§17217. Standard Operating Procedures.
(a) A licensed manufacturer shall establish and maintain written standard operating procedures that are easily accessible to onsite personnel. The standard operating procedures shall, at minimum, include the following:
- Policies or procedures developed in accordance with the security plan required by section 15042.1;
- Emergency response procedures, including safety data sheets for any chemicals onsite;
- Policies and procedures developed in accordance with section 17206;
- Policies and procedures developed in accordance with this article;
- Procedures for complying with the track and trace requirements established in article 6 of chapter 1; and
- Cannabis waste management procedures in compliance with section 17223.
(b) Procedures shall be written in English but may be made available in other languages, as necessary for the licensee’s personnel.
Authority cited: Sections 26013 and 26130, Business and Professions Code.
Reference: Sections 26011.5, 26130 and 26160, Business and Professions Code.
§17218. Inventory Control – Cannabis and Cannabis Products.
(a) A licensed manufacturer shall establish and implement a written inventory control plan capable of tracking the location and disposition of all cannabis and cannabis products at the licensed premises.
(b) A licensed manufacturer shall reconcile the on-hand inventory of cannabis and cannabis products at the licensed premises with the records in the track and trace system at least once every thirty (30) calendar days.
(c) If a licensed manufacturer finds a discrepancy between the on-hand inventory and the track and trace system, the licensee shall conduct an audit.
(d) If the inventory reconciliation conducted pursuant to subsection (b) or the audit conducted pursuant to subsection (c) reveals a discrepancy that is significant pursuant to section 15034, the licensed manufacturer shall notify the Department within 24 hours of the discovery. The result of inventory reconciliation and any audit shall be retained in the licensed manufacturer’s records and shall be made available to the Department upon request.
(e) The licensed manufacturer shall maintain sales invoices and receipts for all batches of cannabis and cannabis products received at and transferred from its licensed premises. The licensed manufacturer shall prepare a sales invoice or receipt that meets the requirements of Business and Professions Code section 26161 prior to each sale or transport of cannabis products from the premises.
Authority: Sections 26013 and 26130, Business and Professions Code.
Reference: Sections 26011.5 and 26130, Business and Professions Code.