FLORIDA MARYLAND MICHIGAN MISSOURI NEW YORK
In need of a third-party audit?
See how CSQ can help!
(c) Provide the department with documentation from a nationally accredited certifying body that the MMTC’s processing facility, including the area where edibles will be produced, has passed a Food Safety Good Manufacturing Practices inspection.
In developing the medical cannabis edibles regulations, the Commission made approval of an edible cannabis product exemption contingent, in part, on the licensee seeking the exemption demonstrating it was certified by an accredited third-party certification body “in an alternative pharmaceutical or dietary supplement certification approved by the Commission.” The regulations do not specify the type of pharmaceutical or dietary supplement certification required, but current Good Manufacturing Practices (cGMP) certification is the standard that the U.S. Food and Drug Administration adopted to ensure safe and effective food, drugs, dietary supplements, and medical devices. In addition, cGMP certifications in drug or dietary supplement manufacturing were discussed while drafting the edible cannabis product exemption regulations and in public meetings as potentially meeting this regulatory requirement. This is because the edible cannabis regulations had the same primary focus as FDAs cGMP regulations: the safe and sanitary receipt, storage, manufacture, transport, use, and disposal of products.
(4) All marihuana producers may become certified to GMP by a body accredited under ISO 17065. This accreditation may enable the licensee certain allowances with testing. The agency will publish those allowances and information on how to obtain approval for allowances. The standard used for certification for GMP must be American National Standards Institute (ANSI) accredited or equivalent.
(5) All marihuana cultivators may become certified to GACP-GMP by a body accredited under ISO 17065. This accreditation may enable the licensee certain allowances with testing. The agency will publish these allowances and information on how to obtain approval for allowances. The standard used for certification for GACP-GMP must be World Health Organization and American Herbal Products Association or equivalent.
(C) Licensees shall implement a quality management system using a published standard, such as those offered by International Organization for Standardization, ASTM International, Cannabis Safety and Quality, or Foundation of Cannabis Unified Standards, within one (1) year of the date the facility receives department approval to operate. The chosen standard shall be applicable to the licensee’s facility type and be implemented with emphasis on regulatory compliance.
Section 1005.4 describes the criteria the Department will use to determine if an applicant’s license should be approved or denied. If an applicant is approved as a cannabinoid hemp processor, the approved applicant must submit the following before receiving the final license: a copy of the certificate of occupancy for the facility, a copy of the applicant’s evidence of a Good Manufacturing Practices (GMP) audit, and the license fee of $4,500 for extracting or $2,000 for manufacturing only. Processor licenses are valid for two years and retailer licenses are valid for one year.