A natural medicine testing facility (NMTF) must meet compliance standards as established by the Colorado Department of Public Health and Environment Rule 5 CCR 1005-7, Natural Medicine Testing Facility Certification and Testing, to analyze natural medicine products.
The NMTF must complete any applicable local licensing prior to requesting certification.
1. If applicable, complete all local licensing.
2. Request certification audit documents from CDPHE and perform self/internal audit inspections using checklists and correct all non-conformances.
The NMTF will download the relevant documents from the list below. Alternatively, the NMTF may email CDPHE (cdphe_naturalmedicine_labcert@state.co.us) and request the certification audit documents. CDPHE will provide the NMTF with any necessary documents including the inspection request form, on-site inspection checklists for self/internal audit, or any other relevant documents.
- Natural medicine certification application packet
- Natural medicine request for application
- Natural medicine general audit checklist
- Natural medicine microbial audit checklist
- Natural medicine tryptamine content audit checklist
3. Submit a request for inspection to CDPHE, along with a quality assurance manual, standard of operations, and curriculum vitae.
After completing a self/internal audit using the audit checklists and correcting all non-conformances, the NMTF will email the request for inspection form signed and dated by the Testing Facility Director to CDPHE at cdphe_naturalmedicine_labcert@state.co.us. In addition, the NMTF will submit its 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, and copies of the ISO 17025 Scope of Accreditation, if available. Once received and accepted, an on-site inspection will be scheduled with the NMTF.
Certification categories: A NMTF may only perform compliance testing in those categories for which they have been certified by CDPHE.
- Microbials.
- Tryptamine content
- Homogeneity
4. CDPHE on-site inspection and report.
CDPHE will inspect the NMTF and evaluate documentation and lab practices to determine if standards of performance, as specified in the 5 CCR 1005-7, Natural Medicine Testing Facility Certification and Testing, are met, including but not limited to: Personnel qualifications, standard operating procedure manuals, analytical processes, proficiency testing, quality control, quality assurance, safety, security, sample tracking, specimen retention, laboratory space, records, and results reporting.
CDPHE will provide an inspection report to the NMTF within 15 calendar days of completion of the on-site inspection process.
5. Provide a written plan of correction to CDPHE within 15 calendar days of receipt of the inspection report.
When applicable, the NMTF must provide a written plan of correction to address all deficiencies to CDPHE within 15 calendar days of receipt of the inspection report. Prior to initial certification, the NMTF must provide evidence of correction of all deficiencies identified during the inspection as described by NMTF in the plan of correction.
6. CDPHE reviews plan of correction and supporting documents to provide recommendations.
7. CDPHE issues certification.
CDPHE will issue initial or ongoing certification — provisional, conditional, or full — based upon approval of the plan of correction and compliance with all applicable requirements. The certification letter will list the approved categories of testing and the specified certification period. Certification may be rescinded at the discretion of the CDPHE.
Additional information
On-site laboratory audit team
The CDPHE State Lab’s Cannabis and Natural Medicines Laboratory Certification Program will perform an annual on-site inspection using the Department’s subject matter expert(s).
Natural Medicine Testing Facility (NMTF) personnel
The NMTF should have sufficient supervisory and other personnel, with the necessary education, training, technical knowledge, and experience for their assigned functions. The NMTF must provide CDPHE with copies of all personnel qualifications, including the Testing Facility Director , whenever initial certification or changes of personnel occur.
The Testing Facility Director may delegate the responsibilities assigned under CDPHE 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 Testing Facility Director is responsible for ensuring that all duties are properly performed.
Personnel competency
A NMTF must have a written system to evaluate and document the competency of testing personnel to perform authorized tests. The NMTF 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 natural medicine products for all approved methods used by the analyst(s), and annually thereafter. Competency assessment 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 natural medicine products.
Standard operating procedures
A NMTF must have a written standard operating procedure manual meeting the minimum standards set forth in the rules detailing the performance of all methods employed by the NMTF to test the analytes it reports. This manual must be made available for testing analysts to follow at all times.
The current Testing Facility Director must approve, sign, and date each standard operating procedure. If any modifications are made to those procedures, the Testing Facility Director must approve, sign, and date the revised version prior to use. Major method modifications must be submitted and approved by CDPHE prior to implementation.
A NMTF 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 as required by 5 CRC1005-7 4.2.5.3 to analytical methods prior to implementation.
Proficiency testing
A NMTF must successfully participate in a CDPHE-approved proficiency testing (PT) program in order to obtain and maintain certification. Review the list of CDPHE approved proficiency testing providers for hemp testing.
Quality assurance and quality control
A NMTF 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 NMTF 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 NMTF must be located in a secure setting to prevent unauthorized persons from gaining access to the testing and storage areas of the laboratory. The NMTF must maintain a listing of all authorized personnel. The NMTF must be 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 NMTF must establish a system to document complete sample tracking for samples from receipt through disposal. All testing of samples and aliquots must be tracked to include any samples sent to other CDPHE-certified NMTFs.
Result reporting and record retention
A NMTF 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, chains of custody, and proficiency testing results.
A NMTF must establish processes to ensure results are reported out within the NMTF’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.
NMTF certification process fees
NMTFs requesting an initial or annual on-site inspection by CDPHE will be invoiced for process fees (if applicable) found in the natural medicine testing facility inspection section of the laboratory fee list
CDPHE-approved proficiency testing providers for natural medicine testing
Emerald Scientific
Contact: Kristen Blake
Phone: 877-567-3598 ext 703 or 877-567-3598
kirsten@emeraldscientific.com
Absolute Standard
Contact: Melissa Stonier
Phone: 203-281-2917 or 1-800-368-1131
melissa@absolutestandards.com
Alternate contact: Candice Warren
Phone: 1-800-368-1131
candice@absolutestandards.com