OFFICE OF MEDICAL CANNABIS - · PDF fileOFFICE OF MEDICAL CANNABIS PRODUCT TESTING &...
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Transcript of OFFICE OF MEDICAL CANNABIS - · PDF fileOFFICE OF MEDICAL CANNABIS PRODUCT TESTING &...
OFFICE OF MEDICAL CANNABIS PRODUCT TESTING & LABORATORY APPROVAL
Joanne Bartkus, PhD, D(ABMM)
Director
Public Health Laboratory
Minnesota Department of Health
Product Testing
• Statutory requirement
“The commissioner shall require each
medical cannabis manufacturer to contract
with an independent laboratory to test
medical cannabis produced by the
manufacturer.”
Why Test Product?
• Each batch of product to be released to consumers to
ensure:
• Safety
• Ensure that product is free of harmful contaminants
• Potency
• Gauge dosage
• Assess cannabinoid profile to maximize patient benefit
• Quality Assurance
• Ensure consistency and quality of product
• Standardization
• Help guide development of industry standards
Stability Testing
• Product tested at time intervals to
assess the stability characteristics o
drug products
• Stability testing used to establish:
• appropriate storage conditions
• expiration dates
• Accelerated studies may be used to
establish tentative expiration date
• Collect actual shelf-life data until
tentative expiration date verified or
appropriate date determined
f
Analyte Categories
• Cannabinoid Profile
• e.g. THC, CBD, CBN, others
• Metals
• e.g. Arsenic, cadmium, lead, mercury
• Pesticides and Plant Growth Regulators
• e.g. abamectin, pyrethrins, bifenazate, daminozide, paclobutrazol,
others.
• Microbial Contaminants and Mycotoxins
• e.g. Viable aerobic bacteria, total coliforms, total yeast and mold
• Residual Solvents
• e.g. acetone, butane, IPA, MeOH, EtOH, many more
Analyte List
• The commissioner will maintain and publish
a detailed list of analytes available for
approval
• Allows for flexibility to add and remove analytes
• List reviewed at least every six months
• Changes published in the State Register and
posted on the program’s website
Interpretive Criteria
• Interpretive criteria, such as
upper contaminant limits yet to
be determined: based on a
review of literature, published
regulations, and consultation
with industry experts
• Collaboration with other states
taking similar approach
Laboratory Approval
“The commissioner shall approve the
laboratory chosen by each manufacturer and
require that the laboratory report testing
results to the manufacturer in a manner
determined by the commissioner.”
Proposed Application Process
• A laboratory may request to be approved by the
commissioner to test the eligible product types
and analytes
• Laboratories are encouraged to operate formal
management systems in accordance to
International Organization for Standardization
(ISO) 17025 General Requirements for the
Competency of Testing and Calibration
Laboratories
Proposed Application Process
• Lab submits application form and required
documentation, such as quality manual and SOPs
• Commissioner will review documentation and will
determine whether award approval if the laboratory's
application meets quality system requirements
• Inspections, announced or unannounced, of
laboratories requesting approval or already approved
laboratories may be conducted.
• Approved laboratories will receive a letter of
compliance
Ongoing Accreditation
• Third party accreditation bodies available
for certification of cannabis testing
laboratories (A2LA, ACLASS)
• It is proposed that the laboratory shall
receive ISO 17025 certification by
December 31, 2016