SAMPLING AND TESTING TECHNICAL GUIDANCE FOR MARIJUANA PRODUCTS Revised July 01, 2021 Supersedes February 11, 2021 Version 4.0 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 INTRODUCTION ............................................................................................................................................................ 1 QUALITY ASSURANCE ................................................................................................................................................ 2 QUALITY ASSURANCE MANUAL ............................................................................................................................. 3 Laboratory organization and responsibility .......................................................................... 3 Standard Operating Procedures (SOPs) ............................................................................. 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 Action ................................................................................................................. 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 Testing .............................................................................................................14 REQUIRED TESTS .................................................................................................................................................. 14 Potency ..............................................................................................................................14 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. 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 STAFF........................................................................................................................................ 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*. .......................................................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