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Transcript of OFFICE OF MEDICAL CANNABIS - · PDF fileOFFICE OF MEDICAL CANNABIS PRODUCT TESTING &...
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OFFICE OF MEDICAL CANNABIS PRODUCT TESTING & LABORATORY APPROVAL
Joanne Bartkus, PhD, D(ABMM)
Director
Public Health Laboratory
Minnesota Department of Health
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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.”
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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
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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
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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
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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
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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
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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.”
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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
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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
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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
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