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

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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

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