ASTM_D_8244_-_21a.pdf

Designation:D824421aStandard Guide forAnalytical Laboratory Operations Supporting the Cannabis/Hemp Industry1This standard is issued under the fixed designation D8244;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revision.A number in parentheses indicates the year of last reapproval.Asuperscript epsilon()indicates an editorial change since the last revision or reapproval.1.Scope1.1 This guide provides recommendations for a laboratorylicensed or otherwise designated to provide analytical supportwithin the cannabis/hemp industry.Within the scope of thisguide,the term cannabis/hemp is inclusive of hemp plants andderived products.This guide presents best laboratory practices,recommended certifications,recommended types of analysestypically required in the cannabis/hemp industry,and recom-mended quality functions associated with laboratories support-ing the cannabis/hemp industry.1.2 These recommendations establish a basis for oversightfor the analytical testing of cannabis/hemp products.Thisguide was developed as a complement to existing best practicesand,in supporting conformance to current good manufacturingpractices(GMP),which are typically required regulatorypractices relevant to the cannabis/hemp industries;these rec-ommendations focus on the personnel,security,sample han-dling and disposal,quality support,data management andreporting activities.1.3 This guide generally describes the properties ofcannabis/hemp,and cannabis/hemp/cannabis-hemp-derivedproducts to be analyzed.1.4 No recommendations found within this guide shallpreclude observance of regulations from authorities havingregional jurisdiction,which may be more restrictive or havedifferent requirements.1.5 This guide applies to all cannabis/hemp containingproducts commercially manufactured and distributed for con-sumer use.1.6 UnitsThe values stated in SI units are to be regardedas the standard.No other units of measurement are included inthis standard.1.7 This guide does not purport to address all laboratorysafety concerns associated with its use.It is the responsibilityof the user of this guide to establish appropriate safety andhealth practices,maintain all safety data sheets(SDS),anddocument safe practices through work instructions and stan-dard operating procedures(SOPs).1.8 This standard does not purport to address all of thesafety concerns,if any,associated with its use.It is theresponsibility of the user of this standard to establish appro-priate safety,health,and environmental practices and deter-mine the applicability of regulatory limitations prior to use.1.9 This international standard was developed in accor-dance with internationally recognized principles on standard-ization established in the Decision on Principles for theDevelopment of International Standards,Guides and Recom-mendations issued by the World Trade Organization TechnicalBarriers to Trade(TBT)Committee.2.Referenced Documents2.1 ASTM Standards:2D8229 Guide for Corrective Action and Preventive Action(CAPA)for the Cannabis IndustryD8245 Guide for Disposal of Resin-Containing CannabisRaw Materials and Downstream ProductsD8270 Terminology Relating to CannabisD8282 Practice for Laboratory Test Method Validation andMethod DevelopmentD8334 Practice for Sampling of Cannabis/Hemp Post-Harvest Batches for Laboratory Analyses2.2 ISO Standards:3ISO/IEC 17025:2017 General Requirements for the Compe-tence of Testing and Calibration LaboratoriesISO 17034:2016 General Requirements for the Competenceof Reference Material Producers2.3 Other Standards:ILACB7:10/2015 MutualRecognitionArrangement(MRA)41This guide is under the jurisdiction of ASTM Committee D37 on Cannabis andis the direct responsibility of Subcommittee D37.03 on Laboratory.Current edition approved June 1,2021.Published June 2021.Originallyapproved in 2020.Last previous edition approved in 2021 as D8244 21.DOI:10.1520/D8244-21A.2For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,refer to the standards Document Summary page onthe ASTM website.3Available from American National Standards Institute(ANSI),25 W.43rd St.,4th Floor,New York,NY 10036,http:/www.ansi.org.4Available from International LaboratoryAccreditation Cooperation(ILAC),theILAC Secretariat,P.O.Box 7507,Silverwater NSW 2128,Australia,http:/ilac.org.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United StatesThis international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for theDevelopment of International Standards,Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade(TBT)Committee.13.Terminology3.1 Definitions:3.1.1 For definitions of terms used in this standard,refer toTerminology D82