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Marijuana inspection: validation guidelines

Any method derived from a standard method or literature method requires validation showing that the method is fit to purpose. In the absence of standard methods, a single laboratory validation or equivalent is required to show that the method is fit for purpose in the intended matrix and, if applicable, that any modifications to the original method do not negatively impact performance. Method validation should, at a minimum, verify accuracy, precision, analytical sensitivity, analytical specificity, limit of detection, limit of quantification, reportable range and the identification of interfering substances. For microbiological methods adopted from a standard method, inclusivity/exclusivity does not require complete reassessment, provided that the referenced media, primers, probes, antibodies, critical chemistries, etc., were not modified. All validations submitted to CDPHE for review must meet the criteria outlined in 1 CCR 212-3, 5-430 (I) and 5 CCR 1005-5 section 7. 

  1. AOAC Cannabis Standard Methods of Performance Requirements (SMPRs): https://www.aoac.org/resources/?topic=Cannabis&type=SMPR&key 
  2. Food and Drug Administration (FDA) 2015. “Analytical Procedures and Methods Validation for Drugs and Biologics: Guidance for Industry.” FDA
  3. Food & Drug Administration Office of Foods and Veterinary Medicine (FDA) 2015. “Guidelines for the Validation of Analytical Methods for the Detection of Microbial Pathogens in Foods and Feeds 2nd Edition.” FDA 
  4. International Conference on Harmonization (ICH) 1996. “Harmonised Tripartite Guideline Validation of Analytical Procedures: Text and Methodology.” ICH ​
  5. United States Department of Agriculture Food Safety and Inspection Service (USDA FSIS) 2010. “Guidance for Test Kit Manufacturers, Laboratories: Evaluating the Performance of Pathogen Test Kit Methods.” USDA 
  6. Opie, S.R. 2019. Cannabis Laboratory Fundamentals. Springer.
  7. European Union Reference Laboratories for Residues of Pesticides. 2021. Analytical Quality Control and Method Validation Procedures for Pesticide Residues Analysis in Food and Feed. SANTE 11312/2021 V2. https://food.ec.europa.eu/system/files/2023-11/pesticides_mrl_guideline…