We can help you obtain a Commercial Cannabis License . We can guide you through the process and manage your Cannabis project.
The Canadian Cannabis license for commercial production provides for two separate licenses for each physical site: a license for raw and plant material and an oil extraction license depending on the intended operations.
The Second Part of the Producers License Application: is the pre-licensing Quality Assurance Report and is the document that requires the most professional time and expense.
This report follows the pre-requisite programmes outlined under the Food Safety and Environmental Program under the Canadian FDA read with the Access to Cannabis for Medical Purposes Regulations. The Quality Assurance Report is signed by the Quality Assurance Person (who we will recommend) and comprises detailed sections with accompanying documentation such as the:
The Premises is defined as not only the physical site where the production facility is located within the perimeter fence, but also encompass the floor plan, the building materials (which must take into account Sanitation and measures to prevent cross contamination), security, and security measures such as access control, and air filtration and odor control. Our Team of experts will assist you in making sure that the proposed premises meets the Health Canada criteria under the Cannabis Regulations.
A comprehensive Pest Control Management plan will be required to ensure that any pests are prevented from contaminating operations. A description of traps, with a blue print overlay over the floor plan depicting the placement and type of traps. In addition, a management plan to include the reporting of pest incidents and prevention measures.
A list of equipment used in the Cannabis operations will be required along with Standard Operating Procedures (SOPS) relating to installation and maintenance of equipment to prevent cross contamination from the equipment itself, the processing environment and the validation and calibration to consistently meet the Good Production Processes to reduce hazards, such as microbial and product cross-contamination will also be required for submission to Health Canada.
This part of the quality assurance report also encompasses the personnel training and retraining schedules, personnel hygiene and dress codes with standard operating procedures for monitoring and control of the personnel activities to prevent cross contamination and product safety. Some sample Standard Operating Procedures (SOPS) for this section will also have to be included in the report to Health Canada on filing.
Proper cleaning and sanitation methods are based on international standards recognized by Health Canada and must be incorporated into other Good Production Practices and their SOPs to prevent cross contamination and contamination by microbial and chemical hazards. Industry standard methods of cleaning will need to be used along with industry standard chemicals and reagents used in the sanitation industry. Critical Standard Operating Procedures (SOPS) for this section will also have to be included in the report to Health Canada on filing.
A description of what the operations comprise from seed to sale, that is: specialised growing medium, growing technology, possible plant varietals, crop frequency, extraction and purification technology etc. These are all areas our subject matter experts will advise you on for their inputs into the Canada Cannabis License process. Again some critical Standard Operating Procedures (SOPS) for this section will also have to be included in the report to Health Canada on filing.
Approximately 70% of Health Canada recalls in the food and pharmaceutical industry is caused by labeling defects. Also, as a part of the Quality Assurance Report, you will be required to accurate describe the product specifications and compliance with this subdivision. A part of these quality assurance requirements for the finished product, the release, labeling, and shipping of finished product. Some Standard Operating Procedures (SOPS) for this section will also have to be included.
A product recall means the product produced is non-complaint with Canadian regulations, AND, has not been detected by the producer. This will also mean formal notification to Health Canada of the recall and the corrective actions taken. Every producer requires a tested product recall system to track, quarantine recalled the product, and correct the problem before production can continue after a recall. Critical Standard Operating Procedures (SOPS) for this section will be required.
Product specifications of the products are described in detail with equivalency calculations and dosages for Cannabis derivatives and testing methodologies that will be done for microbial, and chemical and microbial contaminant according to the US, Canadian or EU Pharmacopeias with tolerance limits for extraneous substances. what procedures are in place to ensure that any changes in these specifications will be approved.
A list of SOPS for all the various prerequisite programs will need to be comprehensively listed.