ASTM_D_8282_-_19.pdf

Designation:D828219Standard Practice forLaboratory Test Method Validation and MethodDevelopment1This standard is issued under the fixed designation D8282;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 The quality,efficacy,and safety of cannabis and prod-ucts containing cannabis extracts shall be evaluated by vali-dated testing methodologies used by trained staffed utilizingqualified instruments and/or materials.1.2 This practice provides the cannabis industry with guid-ance for the development and validation of testing methods thatadequately evaluate cannabis and products containing cannabisextracts for quality,efficacy,and consumer health safety in theabsence of validated methods from agencies.This includes,butis not limited to,the potency of active substances andadulteration,including impurities stemming from potentialadulteration during agricultural or manufacturing processes orboth(for example,pesticides,residual solvents,and the pres-ence of fungus and microorganisms)before product approvaland release for use.Depending on the methodology andprecision and accuracy required,these methods may be bothqualitative or quantitative.1.3 This practice shall define the procedures for test methodcharacterization(TMC),test method validation(TMV),andtest method transfer/transfer of analytical procedures(TMT/TAP)of biological,chemical spectroscopic,and physical-based laboratory test methods.1.4 Depending on the nature of the test in question(chemical,microbiological,etc.)different variables will needto be considered for validation.The particular variables subjectto consideration are beyond the scope of this document.Referto Guide E2857 for more guidance.1.5 This standard does not consider the specifics of accept-able test method limits and users should consult relevantstandard literature to determine the appropriate test parameters.1.6 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.1.7 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:2E2857 Guide for Validating Analytical Methods2.2 Other Documents:United States 40 CFR Appendix B to Part 136 Definitionand Procedure for the Determination of the MethodDetection Limit3USP 1224 Transfer of Analytical ProceduresUSP 1225 Validation of Compendial ProceduresICH Q2(R1)Validation ofAnalytical Procedures:Text andMethodology3.Terminology3.1 Definitions:3.1.1 acceptance criteria,AC,nspecification(s)that shallbe met by a test sample or matrix specific method to beconsidered suitable or validated for use,respectively.3.1.1.1 DiscussionState-specific criteria shall be met asapplicable.3.1.2 accuracy,nthe closeness of agreement between atest result and an accepted reference value.3.1.2.1 DiscussionThe term accuracy,when applied to aset of test results,involves a combination of a randomcomponent and of a common systematic error or bias compo-nent.3.1.3 addendum,ndocument written to make minor up-dates to an existing completed protocol or report.1This practice is under the jurisdiction of ASTM Committee D37 on Cannabisand is the direct responsibility of Subcommittee D37.03 on Laboratory.Current edition approved Sept.1,2019.Published October 2019.DOI:10.1520/D8282-19.2For 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 U.S.Government Printing Office,Superintendent ofDocuments,732 N.Capitol St.,NW,Washington,DC 20401-0001,http:/www.access.gpo.gov.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.3.1.3.1 DiscussionThey may be used when a change inscope of a validation does not occur.3.1.4 analytical method type,ncategorical classificationof a test method that provides general guidance on theanalytical performance characteristics to be c