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ASTM_D_8346_-_21a.pdf

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1、Designation:D834621aStandard Guide forRequirements for Quality Related Professions Within theCannabis and Hemp Industries1This standard is issued under the fixed designation D8346;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the y

2、ear 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 can provide certification bodies,trainingproviders,employers,and certificate issuers,with best-prac-tice

3、guidance for administering their respective programs forquality-related professions within the cannabis and hempindustries.1.2 This guide recommends requirements for experience,training,education,and the body of knowledge(BoK)neces-sary for quality related professions within the cannabis andhemp ind

4、ustries listed in Table 1.1.3 This guide provides recommendations for articulatingprofessional requirements for training and education or earningcertificates.Its content does not supersede requirements fortraining or earning a certificate defined by jurisdictional entitiessuch as government or other

5、 regional regulatory bodies.1.4 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 l

6、imitations prior to use.1.5 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 Organizati

7、on TechnicalBarriers to Trade(TBT)Committee.2.Referenced Documents2.1 ASTM Standards:2D8229 Guide for Corrective Action and Preventive Action(CAPA)for the Cannabis IndustryD8308 Practice for Cannabis/Hemp Operation ComplianceAuditsE2659 Practice for Certificate ProgramsE2708 Terminology for Accredit

8、ation and Certification2.2 Other Standards:21CFR 111 Dietary Supplements321CFR 117 FSMA and Food Safety321CFR 210 Pharmaceutical Packaging and Holding321CFR 211 Pharmaceuticals33.Terminology3.1 Definitions:3.1.1 certificate,na document(letter,card,or other me-dium)awarded to certificate holders that

9、 designates the suc-cessful completion of a credentialing programs requisites.E2659,E27083.1.2 certification agency,nthe organizational or admin-istrative unit that offers or operates,or both,a certificationprogram.E2659,E27083.1.3 certificate program,na non-degree-granting educa-tion of training pr

10、ogram consisting of(1)a learning event orseries of events designed to educate or train individuals toachieve specified learning outcomes within a defined scope,and(2)a system designed to ensure individuals receive acertificate only after verification of successful completion of allprogram requisites

11、,including but not limited to an evaluationof learner attainment of intended learning outcomes.E2659,E27083.1.4 certification,nprocedure and action by a duly au-thorized body of determining,certifying,and attesting inwriting to the qualifications of individuals,processes,procedures,or items in accor

12、dance with application require-ments.3.1.4.1 personnel certification,nprocedure and action bya duly authorized body of determining,verifying,and attestingin writing to the qualifications of individuals in a profession,inaccordance with application requirements associated with thatprofession.E2659,E2

13、7081This guide is under the jurisdiction of ASTM Committee D37 on Cannabis andis the direct responsibility of Subcommittee D37.06 on Personnel Training,Assessment,Credentialing.Current edition approved Nov.1,2021.Published December 2021.Originallyapproved in 2021.Last previous edition approved in 20

14、21 as D8346 21.DOI:10.1520/D8346-21A.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 U.S.Governmen

15、t 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

16、 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.1?3.1.5 standard guide,na compendium of information orseries of options that does not recommend a specific course ofaction.Guides are intended to increase the awareness ofinformation and approaches in a given subject area.3.1.5.1 DiscussionGuides may propose a s

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