Medical Cannabis Laboratory Application Process - Minnesota Dept. of Health

Medical Cannabis Laboratory Approval Program

How to Become an Approved Testing Laboratory

Laboratories can apply to become approved to test medical cannabis products from the registered medical cannabis manufacturers in Minnesota. This is an open application process; labs can apply at any time.

Note: A laboratory applying for this program must have a facility located in Minnesota.

Step 1: Submit application and required documentation

A laboratory requesting approval to provide testing services to the state's medical cannabis manufacturers must submit an application form.

Other required documentation (combine the documents into one PDF and upload through the application):

  • Signed and notarized attestation form stating operational and financial independence from all Minnesota medical cannabis manufacturers.
  • Quality Assurance Manual (see below for requirements).

The quality manual is a document stating the management policies, objectives, principles, organizational structure and authority, responsibilities, accountability, and implementation of an agency, organization, or laboratory, to ensure the quality of its product and the utility of its product to its users. A quality manual must include or reference at a minimum the following sections:

  • Title page with name, address, and phone number of laboratory contact person
  • Effective date of revision
  • Approval signatures (technical director, quality manager, and lab director)
  • Organizational chart
  • Document control procedures
    • Procedure for document approval, issuance, and change. The laboratory must ensure that obsolete documents are suitably marked.
  • Job descriptions
  • Procedures for traceability of measurements
    • Procedure to provide documented historical reconstruction of all laboratory activities that produced the analytical data.
  • List of accredited methods
  • Contract review
    • Procedure to ensure that the client requirements, including the method to be used, are defined, the laboratory has the resources to perform the work, and the appropriate test method is selected to meet the clients' needs.
  • Test procedures (SOP references)
  • Sample handling
  • Major equipment
  • Reference standards
    • Procedure for the calibration of all reference standards (e.g. standards, weights, thermometers, balances).
  • Calibration, verification, and maintenance of equipment
  • Verification procedures (e.g., PT samples, split samples, use of reference materials)
  • Corrective action procedures
    • Procedure to investigate and resolve all instances of non-conformance with policies and/or test methods.
  • Handling complaints
    • Procedure for the resolution of complaints received from customers.
  • Protecting confidentiality
  • Internal audit
    • Procedure and frequency of internal audits.
  • Data review
  • Procedure for data review prior to release of results
  • Training personnel including data integrity and ethics
  • Reporting analytical results, including:
    • Sample test report template
    • List of qualifiers
  • Table of contents, lists of references, glossaries, and appendices
  • Standard Operating Procedure Manual (see below for requirements).

A standard operating procedure is a written document that details the method for an operation, analysis, or action, with thoroughly prescribed techniques and steps. SOPs are officially approved as the methods for performing certain routine or repetitive tasks.

The standard operating procedure manuals must include at a minimum the following sections for each method:

  • Identification of the method/technology (e.g., GC/MS)
  • Applicable matrix or matrices
  • Limits of detection and quantitation
  • Scope and application, including parameters to be analyzed
  • Summary of the method
    • List sample volume, extraction, digestion, concentration, other preparation steps employed, the analytical instrumentation and detector system(s), and the techniques used for quantitative determinations.
  • Definitions
  • Interferences
    • This section should discuss any known interferences specific to the method employed.
  • Safety
  • Equipment and supplies
  • Reagents and standards
    • Provide sufficient details on the concentration and preparation of reagents and standards to allow the work to be duplicated, but avoid lengthy discussions of common procedures.
  • Sample collection, preservation, shipment, and storage
    • Provide information on sample collection, preservation, shipment, and storage conditions.
  • Quality control
    • Describe specific quality control steps and frequencies for each quality control operation and acceptance criteria (see Essential Quality Control Checks below)
  • Calibration and standardization
  • Describe initial calibration procedures, continuing calibration procedures, frequency, and acceptance criteria
  • Data analysis and calculations
    • Describe qualitative and quantitative aspects of the method. Provide equations used to derive final sample result.
  • Method performance
  • Pollution prevention
  • Data assessment and review of data
  • Corrective actions for out-of-control data
  • Contingencies for handling out-of-control or unacceptable data
  • Waste management
  • References
  • Any tables, diagrams, flowcharts, and validation data

Essential Quality Control Checks

The following 12 quality control checks are to be considered essential and must be incorporated into the laboratory's documented quality system, unless a written rationale is provided that indicates why these controls are inappropriate for a specific analytical method. These essential quality control checks are:

  • Demonstration of capability
  • Method detection limit
  • Reagent blank (also referred to as method blank)
  • Laboratory fortified blank (also referred to as a spiked blank, or laboratory control sample)
  • Matrix spike, matrix spike duplicate, or laboratory fortified blank duplicate for suspected difficult matrices
  • Internal standard/s, surrogate standard/s (for organic analysis) or tracer (for radiochemistry)
  • Calibration (initial and continuing)
  • Control charts (or other trend analyses of quality control results)
  • Corrective action (root cause analyses)
  • Specific frequency of quality control checks
  • Quality control acceptance criteria
  • Definitions of a batch (preparation and analytical)
  • Sample handling, receipt, and acceptance procedures and policies (or reference if located in the Quality Assurance Manual or Standard Operating Procedure).
  • Demonstration of laboratory capability and acceptable performance through existing certificates/approvals, documented demonstrations of analytical capabilities, and documented and acceptable proficiency testing samples from an approved provider.
  • Method validation procedures for testing methods.
  • The name and educational qualifications of at least one technical manager responsible for achieving and maintaining the quality and analytical standards of practice.

Step 2: Laboratory site visit

The purpose of the on-site visit is to determine the ability of the laboratory to conduct testing for medical cannabis product for the scope of accreditation requested.

The following records may be reviewed at the onsite visit (other records may be requested, if deemed necessary).

  • Detection limits
  • Training records
  • Temperature logs and calibration records
  • Balance logs and calibration records
  • Equipment maintenance logs
  • Analytical run logs/bench sheets
  • Microbiology logs (media, autoclave, sterility checks)
  • Proficiency results
  • Glassware calibration logs
  • Analytical test reports

Step 3: MDH approval

After site visits are completed and documented, MDH will determine whether or not the laboratory is approved. If approved, MDH will indicate which analytes and methods the laboratory can perform for Minnesota's medical cannabis manufacturers. All approved laboratories must achieve ISO 17025 certification.

Manufacturer contracting

Once a laboratory has received approval for testing from MDH, Minnesota's medical cannabis manufacturers can establish contract relationships with them.

Updated Wednesday, 17-Nov-2021 15:39:58 CST