Designation:D8282−19StandardPracticeforLaboratoryTestMethodValidationandMethodDevelopment1ThisstandardisissuedunderthefixeddesignationD8282;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thequality,efficacy,andsafetyofcannabisandprod-uctscontainingcannabisextractsshallbeevaluatedbyvali-datedtestingmethodologiesusedbytrainedstaffedutilizingqualifiedinstrumentsand/ormaterials.1.2Thispracticeprovidesthecannabisindustrywithguid-anceforthedevelopmentandvalidationoftestingmethodsthatadequatelyevaluatecannabisandproductscontainingcannabisextractsforquality,efficacy,andconsumerhealthsafetyintheabsenceofvalidatedmethodsfromagencies.Thisincludes,butisnotlimitedto,thepotencyofactivesubstancesandadulteration,includingimpuritiesstemmingfrompotentialadulterationduringagriculturalormanufacturingprocessesorboth(forexample,pesticides,residualsolvents,andthepres-enceoffungusandmicroorganisms)beforeproductapprovalandreleaseforuse.Dependingonthemethodologyandprecisionandaccuracyrequired,thesemethodsmaybebothqualitativeorquantitative.1.3Thispracticeshalldefinetheproceduresfortestmethodcharacterization(TMC),testmethodvalidation(TMV),andtestmethodtransfer/transferofanalyticalprocedures(TMT/TAP)ofbiological,chemicalspectroscopic,andphysical-basedlaboratorytestmethods.1.4Dependingonthenatureofthetestinquestion(chemical,microbiological,etc.)differentvariableswillneedtobeconsideredforvalidation.Theparticularvariablessubjecttoconsiderationarebeyondthescopeofthisdocument.RefertoGuideE2857formoreguidance.1.5Thisstandarddoesnotconsiderthespecificsofaccept-abletestmethodlimitsandusersshouldconsultrelevantstandardliteraturetodeterminetheappropriatetestparameters.1.6Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuser...
