Setting the Medical Grade Standard
MedReleaf is setting the Medical Grade Standard™ for product quality and safety because quality assurance is at the core of every plant that we grow and each shipment that we make. Our Quality Assurance team is comprised of seasoned individuals with many years of experience in areas such as the manufacturing of biological implants and the implementation of cutting-edge laboratory technologies. These leading practices help to focus MedReleaf on patient safety, with an emphases on the reporting, analysis, and prevention of medical errors.
MedReleaf’s Commitment to Quality Assurance
MedReleaf is the first and only Licensed Producer to have achieved internationally recognized certifications in respect of its quality and environmental management systems and its occupational health and safety management system. MedReleaf has been certified in accordance with the standards under ISO 9001 (Quality Management System), ISO 14001 (Environmental Management System) and OHSAS 18001 (Occupational Health and Safety Assessment Series), which collectively cover R&D, production, processing, distribution, selling and destruction of medical cannabis.
Our medical cannabis is produced using clean-room technologies, and our facility is designed to exceed Good Production Practices (GPP). Our monitoring begins at seed selection and continues throughout the growing, harvesting, trimming, drying, and packaging phases.
Our Quality Assurance team is focused on bringing pharmaceutical and hospital standards to Canadian medical cannabis patients for the first time. Our operating protocols exceed all Health Canada mandated standards, and we are constantly seeking to push the bar higher. Our product’s quality assurance protocols include those relating to patient safety and risk management and were designed and are overseen by a staff formerly employed at an internationally recognized Canadian hospital. It is our belief that MedReleaf’s quality assurance protocols are amongst the most rigorous in the industry.
MedReleaf also follows the protocols set out below, each of which meets or exceeds the current standards and requirements set by the ACMPR.
- Since the commencement of production of MedReleaf’s cannabis-based pharmaceutical products in 2014, all of our cannabis products have been tested for pesticides by third party laboratories, and we currently test for over 300 contaminants, including pesticides (including myclobutanil), heavy metals, aflatoxins, bacteria and microbials.
- ICH Good Manufacturing Practices – MedReleaf’s production processes meet the requirements of ICH Good Manufacturing Practices, and our Markham Facility was recently assessed to determine whether its production processes meet the requirements of ICH Good Manufacturing Practices. MedReleaf believes that such certification will be received in due course. If obtained, this certification will signify that MedReleaf’s production practices meet stringent pharmaceutical manufacturing requirements that are internationally harmonized in 17 countries including the United States, Canada, Singapore, Japan, Australia and European nations.
- Air Quality: All 10 cultivation rooms at our Markham Facility have been classified and are monitored as ISO Class 8 clean rooms (as defined by the ISO 14644-1 standard), being a standard used in hospital operating rooms.
- Sanitation: Equipment and tools are sanitized using validated cleaners. Over 50 organisms can be destroyed by MedReleaf’s sanitization program, including viruses such as influenza, Human Immunodeficiency Virus (HIV) and Norwalk; bacteria such as Salmonella, Pseudomonas and Listeria; and fungi such as Histoplasma, Aspergillus, Trichophyton and Mycobacterium.
- In-process Quality Control: Written procedures include hundreds of in-process controls which are performed at regular intervals during each manufacturing step. There are over 400 quality control checks performed to ensure the quality of our products. These quality control checks are part of our visual inspections and audits, laboratory reports, raw material reviews, ordering process, irrigation reports, shipping reviews and batch review records.
- Patient Safety Assurance: Every batch of cannabis-based pharmaceutical product released by MedReleaf is tested to confirm that it meets Health Canada specifications. In addition, to enhance the safety of our products, MedReleaf requires its third party laboratory to identify and report any organism found in the product which is not permitted in Health Canada’s specifications. This report is used by MedReleaf’s quality assurance department to evaluate microbial risks prior to releasing any product. MedReleaf believes that this additional layer of analysis provides further safeguards to patients beyond those required by the ACMPR.
- MedReleaf’s Internal Quality Auditing Practices: MedReleaf has a systematic and documented process for evaluating its production operations. Our quality audit program mandates audits to be conducted for each department. Audit reports are compared to our policies and procedures. Any deviations are remediated and a record of the corrective action is maintained. These audits are conducted by staff who are certified for auditing by the American Association of Quality.
- Environmental and Occupational Health and Safety Checks: Using Ministry of Labour-approved and certified staff, MedReleaf conducts regular physical inspections of the Markham Facility and the Bradford Facility to identify and remediate any potential environmental and occupational health and safety concerns.