Sampling and Testing - Technical Guidance for Marijuana ...

1 Sampling AND Testing Technical . Guidance FOR Marijuana . PRODUCTS. Revised July 01, 2021. Supersedes February 11, 2021. Version This information is intended for use by licensed safety compliance facilities and licensed marihuana safety compliance facilities, collectively defined as laboratories, regulated by the Marijuana Regulatory Agency (MRA). This version of the Technical guide combines and replaces all prior iterations published under the purview of MMFLA, MRTMA, MTA and the Administrative Rules. This information does not constitute legal advice and is subject to change. Licensees are encouraged to seek legal counsel to ensure their operations comply with the Medical Marihuana Facilities Licensing Act and associated Administrative Rules. Contents QUALITY ASSURANCE ..2. QUALITY ASSURANCE MANUAL ..3. laboratory organization and responsibility .. 3. Standard Operating Procedures (SOPs).

2 3. Field Sampling procedures .. 4. Instrument calibration procedures .. 4. Analytical procedures .. 4. Data reduction, validation, reporting, and verification .. 5. Quality control (QC) checks and frequency of use .. 5. QUALITY CONTROL REQUIREMENTS ..6. DAILY REQUIREMENTS ..6. Analytical Batch .. 6. laboratory Reagent Blank .. 6. ICV/CCV .. 6. laboratory Fortified Matrix (LFM) / laboratory Fortified Matrix Duplicate (LFMD) .. 7. Duplicate .. 7. ANNUAL REQUIREMENTS ..7. Demonstration of Capability (DOC) .. 7. Method Detection Limit (MDL).. 8. Corrective 8. QC Acceptance .. 8. QC ACCEPTANCE CRITERIA* ..8. DEFINITIONS ..9. STANDARD OPERATING PROCEDURE (SOP) REQUIREMENTS .. 11. VALIDATION REQUIREMENTS .. 11. Analytical chemistry methods: ..13. Microbiological methods:..13. Proficiency REQUIRED TESTS .. 14. Potency ..14. This information does not constitute legal advice and is subject to change.

3 Licensees are encouraged to seek legal counsel to ensure their operations comply with the Medical Marihuana Facilities Licensing Act and associated Administrative Rules. Residual Solvent Testing ..15. Chemical Residue Testing ..15. Heavy Metals ..15. Water Activity ..15. Microbial Assays (Qualitative) ..16. Microbial Assays (Quantitative) ..16. Foreign Matter/Filth Analysis ..16. Vitamin E Acetate ..17. FIELD Sampling .. 17. FIELD Sampling 18. Sampler Qualifications ..18. Sampling IN THE FIELD .. 18. Field Duplicates ..18. Field Audits ..19. Auditing Checks ..19. Field Quality Control ..19. Sample size ..19. Sampling a Batch of Marijuana ..20. Sampling Procedure for Pre-Rolls and Vape Products ..21. Sampling Procedure for Concentrates ..21. Table 1. Batch Sizes for Concentrates*..23. Marijuana -Infused Products (Edibles) ..23. Table 2. Batch Sizes for Marijuana -infused Products*.

4 23. Chain of Custody Documentation ..24. ADDITIONAL Testing GUIDELINES FOR FIELD SAMPLERS .. 25. Testing Marijuana product after failed initial safety Testing ..25. Research and Development (R&D) Testing ..25. REQUIRED SAFETY TESTS AND ACTION LIMITS .. 25. POTENCY .. Error! Bookmark not defined. Concentrates and Flower ..26. Marijuana -infused Products ..27. Table 3. Maximum THC Concentrations for Marihuana-Infused Products..27. This information does not constitute legal advice and is subject to change. Licensees are encouraged to seek legal counsel to ensure their operations comply with the Medical Marihuana Facilities Licensing Act and associated Administrative Rules. TERPENE Testing .. 27. CHEMICAL RESIDUE .. 28. Table 4. List of Banned Chemical Ingredients: Action Limit and LOQ[11]..28. RESIDUAL SOLVENTS .. 29. Table 5. Action Limits for Residual Solvents..30. HEAVY METALS.

5 30. Table 6. Heavy Metal Action Limits..31. FOREIGN MATTER ANALYSIS .. 31. Analysis for Organic Matter ..31. Analysis for Inorganic Matter ..32. WATER ACTIVITY (aw) .. 32. MICROBIALS .. 33. Table 7. Microbial Screening Action Limits (CFU/g)..33. TARGET ANALYTES .. 34. Table 8. Target Analytes for Marijuana product/ Marijuana products Intended for Inhalation..34. 34. pH .. 35. Table 9. Marijuana Testing Requirements..36. APPENDIX A-DEFINITIONS .. 37. 41. Acknowledgments .. 45. This information does not constitute legal advice and is subject to change. Licensees are encouraged to seek legal counsel to ensure their operations comply with the Medical Marihuana Facilities Licensing Act and associated Administrative Rules. Sampling AND Testing Technical Guidance FOR Marijuana PRODUCTS ( ). July 1, 2021. INTRODUCTION. The Marijuana Regulatory Agency (MRA) is committed to evidence-based decision- making when implementing Technical Guidance for licensed laboratories.

6 As research into Marijuana use, safety, and Testing advances, this guide may be revised and updated to reflect these changes where appropriate. Upon receipt of your safety compliance facility/marihuana safety compliance facility license you must comply with all applicable statutes, administrative rules, and Guidance /bulletins issued by the MRA. The Sampling and analysis described in this guide shall be conducted by a laboratory licensed by the MRA and accredited to the international Organization for Standardization (ISO), ISO/IEC 17025 :2017 by an international laboratory accreditation cooperation (ILAC) recognized accreditation body or by an entity approved by the MRA by one year after the date the license is issued in accordance with Rule 5(1)(a) in the Marihuana Sampling and Testing Rule Set (R (1)(a)). accreditation to ISO/IEC 17025 standards demonstrates successful implementation of a quality management system which includes but is not limited to: organizational structure, quality procedures, internal audits, and corrective actions.

7 In addition to the quality management system, Technical matters such as equipment calibration, traceability of controls, relevance of the method, and the validation data will be reviewed by the auditor. Verification of the performance of all methods employed by the laboratory is required. Marijuana safety and potency should be analyzed using Testing methodology validated by an independent third party and approved by the MRA. Analytical Testing of Marijuana for safety and potency is increasingly recognized as a critical and necessary component of the industry for several reasons:[12]. laboratory Testing minimizes the risk of exposure to pesticides, microbes, heavy metals, molds, and residual solvents by providing consumers information about the products they are purchasing and helps to prevent consumption by sensitive populations. Quantification of cannabinoid profiles and potency is available to the consumer to inform decision making and aids in determining appropriate dosing for individual use.

8 laboratory Testing provides transparency and promotes a sense of reassurance to consumers as well as ensuring product quality for the tested Marijuana . 1. Sampling AND Testing Technical Guidance FOR Marijuana PRODUCTS ( ). July 1, 2021. QUALITY ASSURANCE. According to Rule 7(3)(f) in the Marihuana Licensees Rule Set R (3)(f): All laboratories must retain and employ at least one laboratory manager with a relevant advanced degree in a medical or laboratory science. This person must fill the role of a laboratory manager who is responsible for duties including the following: Ensure tests are conducted in accordance with Rule 5 in the Marihuana Sampling and Testing Rule Set R Ensure test results are accurate and precise. Oversee day-to-day operations. Validate reporting requirements in the statewide monitoring system (Metrc). Verify ongoing conformity with ISO 17025 standards.

9 Any other duties required and published by the MRA Rule 7(3)(f) in the Marihuana Licensees Rule Set R (3)(f). All results entered in the statewide monitoring system (Metrc) must be legally valid and defensible. The laboratory should ensure that all test results are legally defensible by keeping thorough and accurate records as well as detailed chain of custody (COC). documents. The quality assurance (QA) plan and/or standard operating procedures (SOPs) should describe the policies and procedures used by the facility for record integrity, retention, and storage. The laboratory must have a procedure for monitoring the validity of results. The resulting data must be recorded in such a way that trends are detectable and, where possible, appropriated statistical techniques shall be applied to analyze and review the results. This monitoring should occur on an ongoing basis and should be reviewed by the laboratory manager/quality assurance manager and shall include, but not be limited to: Use of reference materials or quality control (QC) materials.

10 Functional check(s) of measuring and Testing equipment. Use of certified checks or working standards with control charts, where applicable. Intermediate checks on measuring equipment. Review of reported results. Intra- laboratory comparisons (proficiency Testing ). 2. Sampling AND Testing Technical Guidance FOR Marijuana PRODUCTS ( ). July 1, 2021. Laboratories analyzing Marijuana samples must adhere to all required QC procedures specified in the reference method(s) to ensure that routinely generated analytical data is scientifically valid and defensible and is of known and acceptable precision and accuracy. To accomplish these goals, each laboratory must prepare a written description of its QA. activities, included as part of a Quality Assurance Manual and as part of all relevant SOPs Rule 5(1)(c) in the Marihuana Sampling and Testing Rule Set R (1)(c). It is the responsibility of the laboratory manager/quality assurance manager to keep these documents up to date.