Mich. Admin. Code R. 420.305a - Validations

Rule 5a.

(1) All validations must be submitted to the agency for approval with an acceptable proficiency test that meets the standards in R 420.305(14), where all required analytes are shown to have passed.

(2) Laboratories shall use microbial testing methodologies for the required safety tests in R 420.305 that are sourced from published peer reviewed methods, have been validated for cannabis testing by an independent third party, and have been internally verified by the licensed laboratory according to Appendix J of Official Methods of Analysis authored by the Association of Official Analytical Collaboration (AOAC) International, with guidance from published cannabis standard method performance requirements where available. In the absence of published, peer reviewed, validated cannabis methods, Appendix J of Official Methods of Analysis authored by the Association of Official Analytical Collaboration must be met in full with guidance from the cannabis standard method performance requirements where available. The agency shall approve the validated methodology used by the laboratory and confirm that it produces scientifically accurate results for each safety test it conducts. The agency may monitor a laboratory's microbial methodologies on an ongoing basis. All of the following apply to validated methodologies under this rule:

(a) All validations must be submitted to the agency for approval with an acceptable and graded external proficiency test by a third party, where all required analytes are shown to have passed.

(b) Validation protocols should perform inoculation of marihuana matrices with live organisms where feasible to ensure that both extraction and detection for the assay are tested. To further test the accuracy of the assay, probability of detection (POD) analyses, inclusivity, exclusivity, lot-to-lot stability, and robustness studies must be included in the validation studies.

(c) Methods adopted from a matrix specific standard method, inclusivity and exclusivity do not require a comprehensive reassessment, provided that there were no modifications to the methods, including, but not limited to, all of the following:

(i) Referenced media.

(ii) Primers.

(iii) Probes.

(iv) Antibodies.

(v) Critical chemistries that were not modified.

(d) Microbial methods must include environmental monitoring and quality control of all buffers, media, primers, and incubators.

Notes

Mich. Admin. Code R. 420.305a

2022 MR 5, Eff. 3/7/2022