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 PQPs.
In the food industry, all food processing requires the implementation of Good Manufacturing Practices (GMPs) including a food safety plan. The PQP, which is specific to the California cannabis industry, mirrors the food safety plan and is a requirement for all manufactured cannabis products. The PQP addresses risks and hazards associated with manufactured cannabis products to prevent adulteration and misbranding.
Manufacturers must establish and implement a written PQP that addresses the hazards associated with the premises or the manufacturing process, which, 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.
Types of products that require a PQP
A PQP is required for each type of cannabis product, whether in bulk or final form, manufactured at the licensed premises. Product types include but are not limited to:
- Concentrates
- Edibles
- Infused flower
- Infused pre-rolls
- Tablets
- Tinctures
- Topicals
- Vape cartridges and
- Integrated vaporizers
Each product type requires its own PQP.
Types of hazards that need to be considered in a PQP
The PQP should include a comprehensive assessment of the overall manufacturing process, including:
- Identifying each step from component intake through the transfer of product from the premises
- Evaluating the potential risks associated with each step
- Identifying the preventive measures required to mitigate the potential risks
- Identifying the methods to evaluate and monitor the effectiveness of the preventive measures
- Identifying any action to take if a preventive measure was unsuccessful
The PQP must evaluate potential risks to cannabis product quality that could be introduced during manufacturing, including:
- Biological hazards
- Chemical hazards
- Physical hazards
- Process failures
Manufacturers must identify and implement preventive measures to mitigate each potential risk, as well as methods to evaluate and monitor the effectiveness of these measures. A well-developed and implemented PQP prevents or eliminates product risks thereby facilitating consumer and public confidence in the business’s products.
Regulatory compliance testing does not account for all possible hazards that could be introduced into a product during the manufacturing process. Just because a contaminant is not included in the required compliance testing doesn’t mean it poses no risk to public health.
Manufacturers are responsible for ensuring that the components used are suitable for manufacturing cannabis products and that the cannabis products leaving the premises are not adulterated or misbranded.
Failing to meet this requirement could result in DCC issuing a notice to comply, a citation and fine, a product embargo or recall, and other compliance or licensing actions.
For juices, beverages, and dried meat products
Manufacturers need to develop a Hazard Analysis and Critical Control Program (HACCP) when manufacturing products that have higher food safety risks, such as juices, beverages, and dried meat.
Manufacturing a cannabis juice, cannabis-infused juice, or cannabis beverage requires the manufacturer to prepare a written HACCP that meets the requirements of Title 21 Code of Federal Regulations (CFR) Part 120 Subpart A Section 120.8 and Subpart B Section 120.24.
Manufacturers can use a single document to fulfill both the PQP and HACCP requirements.
Additional information
- Code of Federal Regulations (CFR) Title 21 Part 120 Subpart A Section 120.8
- CFR Title 21 Part 120 Subpart B Section 120.24
- California Code of Regulations (CCR) Title 4 section 17219 Juice Manufacturing
- CCR Title 4 section 17220 Dried Meat Manufacturing
- USDA Food Safety and Inspection Service’s FSIS Compliance Guideline for Meat and Poultry Jerky Produced by Small and Very Small Establishments
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