ASTM_D_8398_-_22.pdf

Designation:D839822Standard Practice forManagement Responsibilities in Managing a QualityManagement System(QMS)1This standard is issued under the fixed designation D8398;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 practice provides the management responsibilitiesfor the implementation and oversight of a quality managementsystem(QMS).It can be applied to all cannabis operations,including cultivation,manufacturing,labeling,dispensing,anddistribution.This practice does not address the quality man-agement system details,but rather focuses on the main con-siderations for managements role in setting up a QMS.GuideD8222 provides an overview and some details about thecomponents of a QMS.Other standards provide details onspecific QMS components.1.2 The term GxPas used in this practice is meant to includethose good practices in the activities included in 1.1;namelycultivation,manufacturing,distribution,and all the relevantfunctions associated with these activities(for example,purchasing,testing,storing,and so forth).1.3 Although this practice mentions the importance ofhealth and safety,it is done so in the context of overallmanagement responsibility.This practice does not addressdetails of a health and safety system,but it identifies theimportance of this as a management responsibility.1.4 This practice encompasses a single component of theQMS(management responsibilities)that,when combined withthe other elements,satisfies the requirements of a completeQMS.1.5 The practices described in this standard are intended toapply to all products of a cannabis plant including those thatcan be classified as hemp and which contain cannabinoids andcan be consumed/ingested via mouth,nose,skin(whetherdescribed as medicine,supplements,food,cosmetics,and soforth.).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:2D8222 Guide for Establishing a Quality Management Sys-tem(QMS)for Consumer Use of Cannabis/Hemp Prod-uctsD8270 Terminology Relating to CannabisD8346 Guide for Requirements for Quality Related Profes-sions Within the Cannabis and Hemp Industries2.2 Other Standards:ISO 9001 Quality Management Systems Requirements3FDA Guidance for Industry Quality Systems Approach toPharmaceutical cGMP Regulations43.Terminology3.1 DefinitionsRefer to Terminology D8270.4.Significance and Use4.1 This practice is for any cannabis operation to use as afundamental part of a robust quality management system(QMS).4.2 Regulators can use this practice to develop regulationsthat require the implementation of QMS principles,specificallymanagements role and responsibilities.Further,regulators can1This practice is under the jurisdiction of ASTM Committee D37 on Cannabisand is the direct responsibility of Subcommittee D37.02 on Quality ManagementSystems.Current edition approved June 1,2022.Published July 2022.DOI:10.1520/D8398-22.2For 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 International Organization for Standardization(ISO),ISOCentral Secretariat,Chemin de Blandonnet 8,CP 401,1214 Vernier,Geneva,Switzerland,https:/www.iso.org.4Available from U.S.Food and Drug Administration(FDA),10903 NewHampshire Ave.,Silver Spring,MD 20993,http:/www.fda.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.1use this practice to help build a checklist to evaluate manage-ments engagement and compliance with QMS based regula-tions.4.3 Auditors would use this practice to assess the level ofmanagement engagement with an operations QMS.4.4 Any cannabis operation that has implemented or seeksto implement a QMS would use this practice.5.Management Capability