ASTM D8398-22
(Practice)Standard Practice for Management Responsibilities in Managing a Quality Management System (QMS)
Standard Practice for Management Responsibilities in Managing a Quality Management System (QMS)
SIGNIFICANCE AND USE
4.1 This practice is for any cannabis operation to use as a fundamental part of a robust quality management system (QMS).
4.2 Regulators can use this practice to develop regulations that require the implementation of QMS principles, specifically management’s role and responsibilities. Further, regulators can use this practice to help build a checklist to evaluate management’s engagement and compliance with QMS based regulations.
4.3 Auditors would use this practice to assess the level of management engagement with an operations QMS.
4.4 Any cannabis operation that has implemented or seeks to implement a QMS would use this practice.
SCOPE
1.1 This practice provides the management responsibilities for the implementation and oversight of a quality management system (QMS). It can be applied to all cannabis operations, including cultivation, manufacturing, labeling, dispensing, and distribution. This practice does not address the quality management system details, but rather focuses on the main considerations for management’s role in setting up a QMS. Guide D8222 provides an overview and some details about the components of a QMS. Other standards provide details on specific QMS components.
1.2 The term GxP as used in this practice is meant to include those good practices in the activities included in 1.1; namely cultivation, manufacturing, distribution, and all the relevant functions associated with these activities (for example, purchasing, testing, storing, and so forth).
1.3 Although this practice mentions the importance of health and safety, it is done so in the context of overall management responsibility. This practice does not address details of a health and safety system, but it identifies the importance of this as a management responsibility.
1.4 This practice encompasses a single component of the QMS (management responsibilities) that, when combined with the other elements, satisfies the requirements of a complete QMS.
1.5 The practices described in this standard are intended to apply to all products of a cannabis plant including those that can be classified as hemp and which contain cannabinoids and can be consumed/ingested via mouth, nose, skin (whether described as medicine, supplements, food, cosmetics, and so forth.).
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
General Information
Standards Content (Sample)
This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: D8398 − 22
Standard Practice for
Management Responsibilities in Managing a Quality
1
Management System (QMS)
This standard is issued under the fixed designation D8398; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope priate safety, health, and environmental practices and deter-
mine the applicability of regulatory limitations prior to use.
1.1 This practice provides the management responsibilities
1.7 This international standard was developed in accor-
for the implementation and oversight of a quality management
dance with internationally recognized principles on standard-
system (QMS). It can be applied to all cannabis operations,
ization established in the Decision on Principles for the
including cultivation, manufacturing, labeling, dispensing, and
Development of International Standards, Guides and Recom-
distribution. This practice does not address the quality man-
mendations issued by the World Trade Organization Technical
agement system details, but rather focuses on the main con-
Barriers to Trade (TBT) Committee.
siderations for management’s role in setting up a QMS. Guide
D8222 provides an overview and some details about the
2. Referenced Documents
components of a QMS. Other standards provide details on
2
2.1 ASTM Standards:
specific QMS components.
D8222 Guide for Establishing a Quality Management Sys-
1.2 ThetermGxPasusedinthispracticeismeanttoinclude
tem (QMS) for Consumer Use of Cannabis/Hemp Prod-
those good practices in the activities included in 1.1; namely
ucts
cultivation, manufacturing, distribution, and all the relevant
D8270 Terminology Relating to Cannabis
functions associated with these activities (for example,
D8346 Guide for Requirements for Quality Related Profes-
purchasing, testing, storing, and so forth).
sions Within the Cannabis and Hemp Industries
1.3 Although this practice mentions the importance of
2.2 Other Standards:
health and safety, it is done so in the context of overall 3
ISO 9001 Quality Management Systems – Requirements
management responsibility. This practice does not address
FDAGuidance for Industry – Quality SystemsApproach to
details of a health and safety system, but it identifies the 4
Pharmaceutical cGMP Regulations
importance of this as a management responsibility.
3. Terminology
1.4 This practice encompasses a single component of the
QMS (management responsibilities) that, when combined with
3.1 Definitions—Refer to Terminology D8270.
the other elements, satisfies the requirements of a complete
QMS.
4. Significance and Use
1.5 The practices described in this standard are intended to
4.1 This practice is for any cannabis operation to use as a
apply to all products of a cannabis plant including those that
fundamental part of a robust quality management system
can be classified as hemp and which contain cannabinoids and
(QMS).
can be consumed/ingested via mouth, nose, skin (whether
4.2 Regulators can use this practice to develop regulations
described as medicine, supplements, food, cosmetics, and so
thatrequiretheimplementationofQMSprinciples,specifically
forth.).
management’s role and responsibilities. Further, regulators can
1.6 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appro-
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website.
1 3
This practice is under the jurisdiction of ASTM Committee D37 on Cannabis Available from International Organization for Standardization (ISO), ISO
and is the direct responsibility of Subcommittee D37.02 on Quality Management Central Secretariat, Chemin de Blandonnet 8, CP 401, 1214 Vernier, Geneva,
Systems. Switzerland, https://www.iso.org.
4
Current edition approved June 1, 2022. Published July 2022. DOI: 10.1520/ Available from U.S. Food and Drug Administration (FDA), 10903 New
D8398-22. Hampshire 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 States
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D8398 − 22
use this practice to help build a checklist to evaluate manage- 6.2.2 Conduct and document an audit of the
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