Back

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

    • Pass
    • Flag
    • Fail

    Personnel policies to mitigate risk of physical, biological, or chemical contamination

    • Pass
    • Flag
    • Fail

    Supervisor and quality control accountability

    • Pass
    • Flag
    • Fail

    Record keeping requirements

    • Pass
    • Flag
    • Fail

    Physical Plant and Grounds

    Sanitation requirements of company grounds and sanitation schedule

    • Pass
    • Flag
    • Fail

    Sanitary waste handling and disposal

    • Pass
    • Flag
    • Fail

    Sanitation and maintenance equipment

    • Pass
    • Flag
    • Fail

    Physical plant sanitation requirements and safe handling of cleaning chemicals

    • Pass
    • Flag
    • Fail

    Pest control requirements

    • Pass
    • Flag
    • Fail

    Designated water supply for production versus hand washing

    • Pass
    • Flag
    • Fail

    Record keeping requirements

    • Pass
    • Flag
    • Fail

    Equipment

    Regular sanitation and maintenance practices and schedules of equipment and utensils

    • Pass
    • Flag
    • Fail

    Regular calibration procedures and schedules of equipment and utensils

    • Pass
    • Flag
    • Fail

    Explicit requirements for specifications of equipment and utensils to mitigate safety risks of equipment and utensil use

    • Pass
    • Flag
    • Fail

    Established guidelines and procedures to ensure equipment and utensils are employed for their intended use

    • Pass
    • Flag
    • Fail

    Record keeping requirements

    • Pass
    • Flag
    • Fail

    Processes and Procedures

    Documented standard operating procedures

    • Pass
    • Flag
    • Fail

    Documented training program for processes and procedures

    • Pass
    • Flag
    • Fail

    Documented record keeping practices

    • Pass
    • Flag
    • Fail

    ocumented specifications for equipment, processes, and final products

    • Pass
    • Flag
    • Fail

    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

    • Pass
    • Flag
    • Fail

    Analytical testing of dried and cured biomass for required metrics and ensure safety

    • Pass
    • Flag
    • Fail

    Regular audits of processes and procedures to ensure best practices are being used and followed

    • Pass
    • Flag
    • Fail

    Extraction and Refinement

    Visual and physical inspection of input material to mitigate risk of contamination

    • Pass
    • Flag
    • Fail

    Analytical testing of input material for confirmation of product quality and calculate final output efficiency

    • Pass
    • Flag
    • Fail

    Visual and physical inspection for quality of extract at crude and refined stages

    • Pass
    • Flag
    • Fail

    Analytical testing of intermediate and final extract product for quality, calculating efficiency, and final product formulation

    • Pass
    • Flag
    • Fail

    Regular audits of processes and procedures to ensure best practices are being used and followed

    • Pass
    • Flag
    • Fail

    Final Product and Formulation

    Visual inspection of all ingredients

    • Pass
    • Flag
    • Fail

    Visual inspection of finished product

    • Pass
    • Flag
    • Fail

    Analytical testing of finished product for required and voluntary testing measures

    • Pass
    • Flag
    • Fail

    Quality control sampling of product to ensure target quality and effects of product are met

    • Pass
    • Flag
    • Fail

    Regular audits of processes and procedures to ensure best practices are being used and followed

    • Pass
    • Flag
    • Fail

    Company Foundation

    Embedding quality control in company culture

    • Pass
    • Flag
    • Fail

    Creating and maintaining policy, procedure, and training program documents

    • Pass
    • Flag
    • Fail

    Regularly self-auditing company grounds, operations, and documentation

    • Pass
    • Flag
    • Fail

    Establishing routine quality control audits completed by a third party auditor

    • Pass
    • Flag
    • Fail

    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)

Please note that any procedure, checklist, or other document available in the MaintainX Procedure Hub is provided for general education and information only and does not constitute legal, medical, or financial advice. MaintainX makes the materials available AS IS and AS PROVIDED, without warranties of any kind. By downloading or using any such materials, you assume the risk that they may not be appropriate for your specific situation and agree that you are solely responsible for any such use, including compliance with applicable law and with meeting any conditions of product warranties.