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).
Quality Assurance Manual 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).
Standard Operating Procedure Manual Requirements
- 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.