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Rule Title: MARIJUANA TESTING LABORATORY QUALITY CONTROL
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Department: PUBLIC HEALTH AND HUMAN SERVICES
Chapter: MARIJUANA REGISTRY
Subchapter: Testing Laboratories
 
Latest version of the adopted rule presented in Administrative Rules of Montana (ARM):

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37.107.309    MARIJUANA TESTING LABORATORY QUALITY CONTROL

(1) The marijuana testing laboratory shall use laboratory quality control (LQC) samples and adhere to good laboratory practices (GLP) in the performance of all quality assurance testing according to the following specifications:

(a) the laboratory shall analyze quality control samples in the same manner as the laboratory analyzes marijuana, marijuana concentrates, marijuana extracts, or marijuana-infused product quality assurance testing samples;

(b) the laboratory shall use at least one negative control and one positive control in each analytical batch for each target organism during microbial testing;

(c) if either of the controls produces unexpected results or fails, then the results for each sample in the analytical batch are invalid and the samples shall be re-prepped and reanalyzed with a new set of controls; and

(d) if the positive and negative controls produce the expected results then the results for each sample in the analytical batch are valid and must be reported.

(2) If the result of the quality control analysis is outside the laboratory's specified acceptance criteria, listed in the laboratory's quality assurance plan, specific method standard operating procedure (SOP), or the product instructions for use, the laboratory shall determine the cause and take corrective action steps to remedy the problem until the result is within the specified acceptance criteria.

(3) The laboratory shall prepare and analyze at least one each of the following quality control samples for each analytical chemistry batch:

(a) method blank;

(b) laboratory control sample (LCS):

(c) laboratory replicate sample; and

(d) laboratory matrix spike sample.

(4) The laboratory shall analyze, at minimum, a continuing calibration verification (CCV) sample at the beginning of each analytical sequence and at least every 10 samples thereafter.

(5) If the result of the quality control analysis is outside the laboratory's specified acceptance criteria, listed in the laboratory's quality assurance plan or specific method SOP, the laboratory shall determine the cause and take corrective action steps to remedy the problem until the result is within the specified acceptance criteria.

(6) If any quality control sample produces a result outside the specified acceptance criteria, the laboratory cannot report the result and the entire batch cannot be released for retail sale. The laboratory shall determine the cause and take steps to remedy the problem until the result is within the specified acceptance criteria.

(7) The laboratory must calculate the method detection limit and method reporting limit for each chemical method analysis according to the United States Food and Drug Administration (USFDA) "Elemental Analysis Manual for Food and Related Products," the United States Environmental Protection Agency (USEPA) "Definition and Procedure for the Determination of the Method Detection Limit, Revision 2," or a substantially equivalent standard.

 

History: 50-46-344, MCA; IMP, 50-46-304, 50-46-311, 50-46-326, 50-46-344, MCA; NEW, 2019 MAR p. 1868, Eff. 10/19/19.


 

 
MAR Notices Effective From Effective To History Notes
37-889 10/19/2019 Current History: 50-46-344, MCA; IMP, 50-46-304, 50-46-311, 50-46-326, 50-46-344, MCA; NEW, 2019 MAR p. 1868, Eff. 10/19/19.
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