Manufacturers extract cannabinoids and terpenes from cannabis plants and make products out of the extract. The types of products they make vary widely and include:
- Concentrates
- Edibles
- Infused flower
- Infused pre-rolls
- Tablets
- Tinctures
- Topicals
- Vape cartridges
- Integrated vaporizers
Cannabis manufacturers use techniques and processes common in other types of consumer product manufacturing. Manufacturing steps differ based on the type of manufacturing, but generally include:
- Extraction of cannabinoids
- Post-processing (refinement) of cannabis extract
- Infusion of extract or plant material with other ingredients
- Packaging and labeling cannabis products
Manufacturing licenses
You need a manufacturing license to make cannabis products in California. The type of manufacturing license you need depends on:
- What activities you do
- Whether you do extraction and post processing
- What types of chemicals you use (if any)
You need a different license if you manufacture in a shared-use facility.
Learn more about manufacturing license types.
Closed-loop extraction system
Checklist: closed-loop extraction systems
Cannabis manufacturers who utilize closed-loop extraction systems must ensure their extraction systems are operated and maintained according to the requirements established by DCC. These requirements govern the use of volatile or asphyxiating solvents, or flammable liquids, permissible extraction types, closed-loop extraction systems, and the continued certification of closed-loop extraction systems. This document is intended to outline the requirements that closed-loop extraction system operators must follow to ensure the compliant use of extraction systems.
Good manufacturing practices (GMPs)
DCC’s regulations require manufacturers to follow good manufacturing practices (GMPs) when making products. GMPs help ensure products are:
- Free of contaminants and safe for consumers
- Produced consistently every time
- Labeled correctly
Manufacturers must demonstrate GMPs by establishing and implementing a robust quality control program. The quality control program must describe how the manufacturer will comply with the following:
- Standards for the interior, exterior, and grounds of the manufacturing facility
- Requirements for the design, construction, installation, cleaning, sanitation, and maintenance of equipment and utensils used for manufacturing
- Procedures for manufacturing personnel to protect against allergen cross-contact and contamination of cannabis, cannabis products, components, contact surfaces, and packaging materials by microorganisms or foreign substances
- Policies and procedures to prevent adulteration of cannabis products and to ensure and maintain the quality of product components and
- Procedures that ensure cannabis quality including:
- Product quality plans
- Master manufacturing protocols and
- Batch production records
Manufacturers must keep up-to-date documents with their procedures and instructions for making products.
Documenting GMPs
The product quality plan (PQP), master manufacturing protocol (MMP), and batch production record (BPR) are all part of the quality control program and critical to documenting GMPs. These documents are like the three points of a triangle, all necessary but focused on a specific goal.
The PQP is a foundational document that outlines each point, step, and/or stage in the manufacturing process. The PQP focuses on identifying, preventing, monitoring, and taking corrective action for the different risks and hazards that may cause the product to be adulterated or misbranded or cause the product to fail laboratory testing or quality assurance review.
The MMP is an organizing document that lists the written instructions for each point, step, or stage in the manufacturing process. Following the instructions in the MMP for each unique formulation and batch of cannabis product ensures the mitigation of any hazards identified in product quality and batch uniformity.
The BPR is a separate document from the PQP and MMP, created for each distinct production batch, that includes all points, steps, and/or stages in the manufacturing process. The BPR records information about the manufacturing process that confirms the manufacturer used the monitoring methods identified in the PQP and followed the MMP for each production batch.
Specifically, the BPR must capture actual values and observations obtained during monitoring or verification activities. Additionally, the BPR must include documentation that quality control personnel reviewed all required monitoring operations and approved, released, or rejected the finished cannabis product.
Product quality
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Product Quality Plan (PQP)
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…
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Product Quality Plan: FAQs
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:…
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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.
