A marijuana testing facility (MTF) must meet standards of performance as established by the Colorado Department of Revenue Rule 1 CCR 212-2. The MTF must receive a business license from the Marijuana Enforcement Division prior to requesting certification.
Printable version of the Marijuana Testing Facility Certification Process
Sections
Process | Additional information | MTF certification process fees | MTF certification process resources | Email information
Process
1. Receive a marijuana testing facility (MTF) state license from the Marijuana Enforcement Division.
2. Request certification audit documents from the State Lab at the Colorado Department of Public Health and Environment and perform self/internal audit inspections using the lists below. Correct all non-conformances.
The MTF will download the relevant documents from the list below.
Alternatively, the MTF may email CDPHE at cdphe_marijuana_labcert@state.co.us and request the certification audit documents. CDPHE will provide the MTF with any necessary documents to include the inspection request form, onsite inspection checklists for self/internal audit, or any other relevant documents.
- Request for inspection form.
- General lab practices audit checklist (applicable to all testing categories).
- Elemental impurities audit checklist.
- Microbiology audit checklist.
- Water activity audit checklist.
- Mycotoxins audit checklist.
- Pesticides audit checklist.
- Residual solvents audit checklist.
- Cannabinoid concentration audit checklist.
3. Submit a request for inspection, quality assurance manual, standard of operations, and curriculum vitae to CDPHE.
The MTF must complete a self/internal audit using the audit checklists and correct all non-conformances. The MTF will then email the signed and dated request for inspection form to CDPHE at cdphe_marijuana_labcert@state.co.us.
In addition, the MTF will submit:
- Self/internal audit and completed CDPHE audit checklists (completed checklists must provide the document or location where evidence of each requirement may be found)
- Quality assurance manual
- Standard operating procedures
- Validation report
- Curriculum vitae/resumes for all staff
- Copies of the ISO 17025 Scope of Accreditation (initial applicants have one year post-certification to obtain ISO accreditation)
Once received and accepted, CDPHE will schedule an on-site inspection with the MTF.
4. CDPHE on-site inspection and report.
CDPHE will inspect the MTF and evaluate documentation and lab practices to determine if standards of performance, as specified in the 1 CCR 212-3, are met including, but not limited to: Personnel qualifications, standard operating procedure manuals, analytical processes, proficiency testing, quality control, quality assurance, security, sample tracking, specimen retention, laboratory space, records, and results reporting.
CDPHE will provide an inspection report to the MTF within 15 calendar days of completion of the on-site inspection process.
Certification categories: A MTF may only perform compliance testing in those categories for which they have been certified by CDPHE.
- Microbials
- Mycotoxins
- Pesticides
- Residual solvents
- THC and other cannabinoid potency
- Elemental impurities
- Water activity
5. Provide a written plan of correction to CDPHE within 15 calendar days of receipt of inspection.
When applicable, the MTF must provide a written plan of correction to CDPHE within 15 calendar days of receipt of the inspection report. Prior to initial certification, the MTF must provide evidence of correction of all deficiencies identified during the inspection as described by MTF in the plan of correction.
6. CDPHE reviews plan of correction and supporting documents to provide recommendations.
CDPHE will issue a letter of recommendation to the Marijuana Enforcement Division. The certification letter will list the approved testing categories and the specified certification period, unless rescinded at the discretion of the Marijuana Enforcement Division.
Additional information
On-site laboratory audit team
The State Lab’s Cannabis Laboratory Certification Program will perform an annual on-site inspection using the Department’s subject matter expert(s).
Marijuana testing facility (MTF) personnel
The MTF should have sufficient supervisory and other personnel, with the necessary education, training, technical knowledge, and experience for their assigned functions. Copies of all personnel qualifications, including the laboratory director, must be provided to the CDPHE whenever initial certification or changes of personnel occur.
The laboratory director may delegate the responsibilities assigned under Marijuana Enforcement Division rule to a qualified supervisory analyst, provided that such delegation is made in writing and a record of the delegation is maintained. Despite the designation of a responsibility, the laboratory director remains responsible for ensuring that all duties are properly performed.
Personnel competency
A MTF must have a written system to evaluate and document the competency of testing personnel to perform authorized tests. The MTF must establish and follow competency assessment policies. Competency assessments must occur and be documented for all analyst(s) prior to testing and reporting test results for marijuana or marijuana products for all approved methods used by the analyst(s), and annually thereafter. Competency assessments must occur and be documented for all analyst(s) whenever new methods are used, or changes to existing methods are made prior to testing and reporting results on marijuana or marijuana products.
Standard operating procedures
A MTF must have a written procedure manual meeting the minimum standards set forth in the rules detailing the performance of all methods employed by the laboratory to test the analytes it reports. This manual must be made available for testing analysts to follow at all times.
The current laboratory director must approve, sign, and date each standard operating procedure. If any modifications are made to those procedures, the laboratory director must approve, sign, and date the revised version prior to use.
A MTF must maintain a listing of all analytical methods being used and all analytes tested and reported. Copies of these methods must be made available upon request. CDPHE must be informed of any major changes to analytical methods prior to implementation.
Proficiency testing
A MTF must successfully participate in a Marijuana Enforcement Division-approved proficiency testing program in order to obtain and maintain certification.
Quality assurance and quality control
A MTF must establish and follow a quality assurance and quality control program to ensure sufficient monitoring of laboratory processes and the quality of results reported. Corrective actions taken by the MTF must be documented and reviewed on an ongoing basis by qualified personnel to evaluate the effectiveness of the corrective actions taken over time.
Facility
A MTF must be located in a secure setting to prevent unauthorized people from gaining access to the testing and storage areas of the laboratory. The MTF must maintain a listing of all authorized personnel. The MTF must be located in a fixed structure that provides adequate infrastructure to perform the analysis in a safe and compliant manner consistent with federal, state, and local requirements.
Sample tracking
A MTF must establish a system to document complete sample tracking for samples from receipt through disposal. The MTF must track all testing of samples and aliquots to include any samples sent out to other Marijuana Enforcement Division-certified marijuana testing facilities.
Result reporting and record retention
A MTF must establish a system to retain and maintain records for a minimum of three years, plus the current year. Retention of records includes, but is not limited to: Personnel, standard operating procedures, test results to include instrument printouts, quality control and quality assurance records, chain of custody, and proficiency testing results.
A MTF must establish processes to ensure results are reported out within the MTF’s established turnaround times. All data required by rule must be reported, including measurement uncertainty, and quality control data must be reported upon client request.
MTF certification process fees
CDPHE will invoice MTFs requesting an initial or annual on-site inspection for process fees (if applicable) found in the marijuana laboratory inspection section of the laboratory fee list.
MTF certification process resources
Marijuana Enforcement Division (MED)-approved proficiency testing (PT) providers
Email information
Certification of marijuana testing facilities: cdphe_marijuana_labcert@state.co.us