Cannabis Processing Quality Control Checkpoints
This inspection checklist is intended to assist the medical cannabidiol dispensary in becoming operational. . It also contains information that the Office of Medical Cannabidiol will monitor for regulatory compliance as the dispensary continues operations.
MaintainX
07/19/2022
Cannabis Processing Quality Control Checkpoints
This inspection checklist is intended to assist the medical cannabidiol dispensary in becoming operational. . It also contains information that the Office of Medical Cannabidiol will monitor for regulatory compliance as the dispensary continues operations.
Current Good Manufacturing Practice
The FDA has established systems that assure proper design, monitoring, and control of manufacturing processes and facilities based on the type of consumer product (for example, drugs, supplements, and food)
The FDA defines current good manufacturing practices (CGMPs) for a drug product and production of food as:
For more clearly defined best practices, companies can look to the federal CGMPs and the Code of Federal Regulations (CFR) provided by the FDA. A few important guidelines from the drug and food CGMPs are listed below.
Personnel
Hygienic practices to prevent microbial contamination from sick or infected personnel
Personnel policies to mitigate risk of physical, biological, or chemical contamination
Supervisor and quality control accountability
Record keeping requirements
Physical Plant and Grounds
Sanitation requirements of company grounds and sanitation schedule
Sanitary waste handling and disposal
Sanitation and maintenance equipment
Physical plant sanitation requirements and safe handling of cleaning chemicals
Pest control requirements
Designated water supply for production versus hand washing
Record keeping requirements
Equipment
Regular sanitation and maintenance practices and schedules of equipment and utensils
Regular calibration procedures and schedules of equipment and utensils
Explicit requirements for specifications of equipment and utensils to mitigate safety risks of equipment and utensil use
Established guidelines and procedures to ensure equipment and utensils are employed for their intended use
Record keeping requirements
Processes and Procedures
Documented standard operating procedures
Documented training program for processes and procedures
Documented record keeping practices
ocumented specifications for equipment, processes, and final products
Current established quality control checkpoints for operations after the plant has been harvested are discussed below.
Biomass
Visual inspection of biomass to check for quality
Analytical testing of dried and cured biomass for required metrics and ensure safety
Regular audits of processes and procedures to ensure best practices are being used and followed
Extraction and Refinement
Visual and physical inspection of input material to mitigate risk of contamination
Analytical testing of input material for confirmation of product quality and calculate final output efficiency
Visual and physical inspection for quality of extract at crude and refined stages
Analytical testing of intermediate and final extract product for quality, calculating efficiency, and final product formulation
Regular audits of processes and procedures to ensure best practices are being used and followed
Final Product and Formulation
Visual inspection of all ingredients
Visual inspection of finished product
Analytical testing of finished product for required and voluntary testing measures
Quality control sampling of product to ensure target quality and effects of product are met
Regular audits of processes and procedures to ensure best practices are being used and followed
Company Foundation
Embedding quality control in company culture
Creating and maintaining policy, procedure, and training program documents
Regularly self-auditing company grounds, operations, and documentation
Establishing routine quality control audits completed by a third party auditor
Quality Control Testing
Most states require final products to be tested for the following measures:
Flower:
Concentrates and infused products:
Weaknesses in Quality Assurance and Quality Control
Several problems have led to weaknesses in quality assurance and quality control, including:
Source: MaintainX (Community Member)