Mont. Admin. r. 42.39.609

Current through Register Vol. 23, December 6, 2024

Rule 42.39.609 - TESTING LABORATORY QUALITY CONTROL

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

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

(b) the testing 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 laboratory test sample results in the analytical batch are valid and must be reported.

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

(a) method blank (MB);

(b) laboratory control sample (LCS);

(c) replicate (REP); and

(d) matrix spike (MS).

(3) The testing laboratory shall analyze an initial calibration verification (ICV) sample immediately following an instrument calibration.

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

(5) If any quality control sample result is outside the testing laboratory's specified acceptance criteria listed in the testing laboratory's quality assurance plan , specific method SOP, or product instructions for use, the testing 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 testing laboratory cannot report the result and the entire analytical batch cannot be released for sale. The testing laboratory shall determine the cause and take steps to remedy the problem until the result is within the specified acceptance criteria.

(7) The testing laboratory must calculate the method detection limit (MDL) and method reporting limit (MRL) 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.

Mont. Admin. r. 42.39.609

NEW, 2019 MAR p. 1868, Eff. 10/19/2019; AMD, 2022 MAR p. 58, Eff. 1/15/2022; TRANS, from 37.107.309, 2023 MAR p. 570, Eff. 7/2/2023

AUTH: 16-12-202, 16-12-209, MCA; IMP: 16-12-202, 16-12-209, MCA