These FAQs address common questions about Product Quality Plans (PQPs) for manufacturers, including how PQPs support a quality control program, when they are required, and how they are reviewed. Use this page to understand key expectations and clarify how PQPs help maintain compliance.
Q: How do PQPs fit into a manufacturer’s quality control program?
A: The PQP is part of the quality control program. While a single quality control program applies to the premises, each PQP is product specific. Therefore, manufacturers producing a variety of products must create and maintain multiple product quality plans.
Q: Is a PQP the same as an employee health and safety plan?
A: A PQP is different than an employee health and safety plan. The PQP addresses hazards and risks a product may pose to consumers rather than employees.
Employee health and safety plans prevent workplace accidents, injuries, and occupational health risks, ensuring the well-being of employees.
Additional information
Q: Is inaccurate cannabinoid concentration a hazard that manufacturers must consider in their PQP?
A: Consumers expect that the cannabinoid content listed on a cannabis product label is accurate. Consuming an amount of cannabinoids that is different from what’s on the label (beyond the allowable 10% deviation) may lead to an unintended reaction and is considered a public health risk.
Misrepresenting the cannabinoid content by more than a 10% deviation constitutes a form of adulteration, as the product’s concentration differs from what the label represents, and it is misbranded because its labeling is false or misleading. Accurate concentrations must be considered and addressed in each PQP.
Additional information
Q: Will DCC inform manufacturers about the hazards associated with their products and what they must do to mitigate them?
A: DCC does not consult on the different hazards and mitigation strategies associated with the facility or the manufacturing of various cannabis products. It is the manufacturer’s responsibility to evaluate risks and hazards and to determine how to mitigate them.
Many resources are available online, including training and certifications offered by third-party providers and consultants who assist companies in building their PQPs and Hazard Analysis and Critical Control Plans (HACCP).
Q: Will DCC provide manufacturers with a list of brand names for raw materials that do not pose hazards?
A: DCC does not keep a list of brands used. Manufacturers may utilize the Food and Drug Administration (FDA) Generally Recognized as Safe (GRAS) database. Manufacturers are encouraged to source raw materials from reputable entities that have documentation supporting accreditation and compliance with existing relevant regulatory bodies, such as the FDA Food Safety Modernization Act (FSMA) program.
Manufacturers must obtain food components only from sources that comply with federal and state food laws. Always obtain and review product specification sheets from the suppliers for the raw materials sourced. Reviewing product specification sheets is essential for verifying that the raw materials meet the required quality standards. It is best practice to capture non-cannabis ingredient lot numbers within your batch production record(s) for tracking purposes.
Additional information
Q: When a manufacturer purchases bulk food or premixes from a supplier to use for further manufacturing, packaging, or labeling, does the PQP need to consider the ingredients the supplier used in the bulk food or premix product?
A: Acquiring the ingredient list or specification sheet for bulk food or premixes purchased from a supplier is essential to evaluating the hazards associated with the use of ingredients and raw materials in manufacturing.
Product specification sheets provide details on shelf life, storage requirements, potential allergens, water activity, pH measurements, and special handling procedures that may be critical in ensuring product safety. It is best practice to obtain information about product transportation and storage conditions, packaging, and processing and handling methods.
Q: Can a manufacturer write one PQP for all the different cookies they make? Or do they need to write a PQP for each flavor or cookie SKU?
A: Every product with a different formulation and/or manufacturing process carries distinct risks that the PQP must address.
A product formulation varies based on the quantity and identity of each component (including hardware). Manufacturing processes encompass operational parameters, the equipment and utensils used, and the premises where the manufacturing activity takes place.
Products such as edibles with different formulations or manufacturing processes would require more than one PQP to address potential allergen risks and other chemical or biological hazards that may be present in a particular formulation. However, some products may share some elements of a PQP, depending on the similarities between their formulations and manufacturing processes.
Q: Another manufacturer has a PQP for chocolate chip cookies, and I make chocolate chip cookies. Can I use that manufacturer’s PQP?
A: The PQP must be specific to the product formulation and the manufacturing process at your premises. You are using different equipment and different manufacturing processes at your premises, and this requires you to create a unique PQP for your cannabis product.
Q: What if a manufacturer doesn’t have a PQP for their products?
A: It is unlawful to cultivate, manufacture, distribute, sell, deliver, hold, or offer for sale adulterated cannabis or cannabis products.
Cannabis products manufactured in a facility where the methods, facilities, or controls used for its manufacture, packing, or holding do not conform to or are not operated or administered in conformity with practices established by DCC regulations for safety or do not have the concentrations it purports or fails to meet the quality and purity characteristics that it purports or represents to possess are considered adulterated.
Failure to establish, implement, and provide PQPs for each product type manufactured may result in a citation, embargo, recall, or license action.
Additional information
Q: What if the manufacturer sources a product that has a HACCP or a food safety plan and infuses it by adding cannabis oil? Can either of those plans be used as the PQP?
A: Adding cannabis to a sourced non-cannabis product is considered a new manufacturing process and an alteration of the source product. Infusing a source product with cannabis requires the development and implementation of a PQP (and a HACCP as required for juice, beverages, or dried meat manufacturing) to assess any additional hazards introduced by altering the product (i.e., adding the cannabis oil).
Related resources
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Allergen guidance
Find out more about creating an effective allergen control program, as well as an overview of the major food allergens and where they are commonly found in cannabis products.
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Batch production record checklist
A Batch Production Record is a detailed, written documentation of the work performed to manufacture or remediate a batch of cannabis or cannabis product.
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Master manufacturing protocol checklist
The Master Manufacturing Protocol is a written document that describes how to make a cannabis product. It lists the type and amount of each ingredient to use and each step that must be followed to safely and consistently produce the product.
