ASTM D8244-21

Standard Guide for Analytical Laboratory Operations Supporting the Cannabis/Hemp Industry

SIGNIFICANCE AND USE
4.1 Laboratories are integral to cannabis/hemp industry operations and consumer safety and satisfaction. Standardized laboratory practices play a key role in establishing and demonstrating product safety, quality, and compliance with the regulations that govern product quality and safety.  
4.2 This guide is intended for use by laboratories as an overview of best practices for operations providing support to the cannabis/hemp industry and its many products. This guide is based on the best practices as articulated in the FOCUS (Foundation of Cannabis Unified Standards) and AHPA (American Herbal Products Association) standards, as well as GMP compliance guidelines.5, 6  
4.3 The contents of this guide reflect the typical requirements imposed by different laboratory regulatory guidelines. It provides recommendations to laboratory operations, GMP, personnel competency, proficiency testing, facility operations, security, sample transfer and receipt, sample handling and disposal, equipment and reagent considerations, reference standards, analytical procedures, data processing and handling, quality assurance, traceability, and accreditation recommendations.  
4.4 This guide is recommended for use by cannabis/hemp laboratory personnel involved in cannabis/hemp laboratory operations.
SCOPE
1.1 This guide provides recommendations for a laboratory licensed or otherwise designated to provide analytical support within the cannabis/hemp industry. Within the scope of this guide, the term cannabis/hemp is inclusive of hemp plants and derived products. This guide presents best laboratory practices, recommended certifications, recommended types of analyses typically required in the cannabis/hemp industry, and recommended quality functions associated with laboratories supporting the cannabis/hemp industry.  
1.2 These recommendations establish a basis for oversight for the analytical testing of cannabis/hemp products. This guide was developed as a complement to existing best practices and, in supporting conformance to current good manufacturing practices (GMP), which are typically required regulatory practices relevant to the cannabis/hemp industries; these recommendations focus on the personnel, security, sample handling and disposal, quality support, data management and reporting activities.  
1.3 This guide generally describes the properties of cannabis/hemp, and cannabis/hemp/cannabis-hemp-derived products to be analyzed.  
1.4 No recommendations found within this guide shall preclude observance of regulations from authorities having regional jurisdiction, which may be more restrictive or have different requirements.  
1.5 This guide provides guidelines for laboratories supporting compliance GMP.  
1.6 This guide applies to all cannabis/hemp containing products commercially manufactured and distributed for consumer use.  
1.7 Units—The values stated in SI units are to be regarded as the standard. No other units of measurement are included in this standard.  
1.8 This guide does not purport to address all laboratory safety concerns associated with its use. It is the responsibility of the user of this guide to establish appropriate safety and health practices, maintain all safety data sheets (SDS), and document safe practices through work instructions and standard operating procedures (SOPs).  
1.9 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.  
1.10 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 (T...

General Information

• Status: Historical
• Publication Date: 14-Jan-2021
• ICS: 71.040.10 - Chemical laboratories. Laboratory equipment
• Technical Committee: D37 - Cannabis
• Drafting Committee: D37.03 - Laboratory

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: D8244 − 21
Standard Guide for
Analytical Laboratory Operations Supporting the Cannabis/
1
Hemp Industry
This standard is issued under the fixed designation D8244; 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 1.7 Units—The values stated in SI units are to be regarded
as the standard. No other units of measurement are included in
1.1 This guide provides recommendations for a laboratory
this standard.
licensed or otherwise designated to provide analytical support
within the cannabis/hemp industry. Within the scope of this 1.8 This guide does not purport to address all laboratory
guide, the term cannabis/hemp is inclusive of hemp plants and safety concerns associated with its use. It is the responsibility
derived products.This guide presents best laboratory practices, of the user of this guide to establish appropriate safety and
recommended certifications, recommended types of analyses health practices, maintain all safety data sheets (SDS), and
typically required in the cannabis/hemp industry, and recom- document safe practices through work instructions and stan-
mended quality functions associated with laboratories support- dard operating procedures (SOPs).
ing the cannabis/hemp industry.
1.9 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the
1.2 These recommendations establish a basis for oversight
responsibility of the user of this standard to establish appro-
for the analytical testing of cannabis/hemp products. This
priate safety, health, and environmental practices and deter-
guidewasdevelopedasacomplementtoexistingbestpractices
mine the applicability of regulatory limitations prior to use.
and, in supporting conformance to current good manufacturing
1.10 This international standard was developed in accor-
practices (GMP), which are typically required regulatory
dance with internationally recognized principles on standard-
practices relevant to the cannabis/hemp industries; these rec-
ization established in the Decision on Principles for the
ommendations focus on the personnel, security, sample han-
Development of International Standards, Guides and Recom-
dling and disposal, quality support, data management and
mendations issued by the World Trade Organization Technical
reporting activities.
Barriers to Trade (TBT) Committee.
1.3 This guide generally describes the properties of
cannabis/hemp, and cannabis/hemp/cannabis-hemp-derived
2. Referenced Documents
products to be analyzed.
2
2.1 ASTM Standards:
1.4 No recommendations found within this guide shall
D8229 Guide for Corrective Action and Preventive Action
preclude observance of regulations from authorities having
(CAPA) for the Cannabis Industry
regional jurisdiction, which may be more restrictive or have
D8245 Guide for Disposal of Resin-Containing Cannabis
different requirements.
Raw Materials and Downstream Products
D8270 Terminology Relating to Cannabis
1.5 This guide provides guidelines for laboratories support-
D8282 Practice for Laboratory Test Method Validation and
ing compliance GMP.
Method Development
1.6 This guide applies to all cannabis/hemp containing
3
2.2 ISO Standards:
products commercially manufactured and distributed for con-
ISO/IEC 17025:2017 General Requirements for the Compe-
sumer use.
tence of Testing and Calibration Laboratories
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
1
This guide is under the jurisdiction ofASTM Committee D37 on Cannabis and contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
is the direct responsibility of Subcommittee D37.03 on Laboratory. Standards volume information, refer to the standard’s Document Summary page on
Current edition approved Jan. 15, 2021. Published February 2021. Originally the ASTM website.
3
approved in 2020. Last previous edition approved in 2020 as D8244 – 20. DOI: Available from American National Standards Institute (ANSI), 25 W. 43rd St.,
10.1520/D8244-21. 4th Floor, New York, NY 10036, http://www.ansi.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
D8244 − 21
ISO 17034:2016 General Requirements for the Competence
of Reference Material Producers
1

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D8244 − 21
2.3 Other Standards: provides recommendations to laboratory operations, GMP,
ILAC B7:10/2015 Mutual Recognition Arrangement personnel competency, proficiency testing, facility operations,
4
(
...

This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: D8244 − 20 D8244 − 21
Standard Guide for
Analytical Laboratory Operations Supporting the
1
CannabisCannabis/Hemp Industry
This standard is issued under the fixed designation D8244; 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
1.1 This guide provides recommendations for a laboratory licensed or otherwise designated to provide analytical support within
the cannabiscannabis/hemp industry. Within the scope of this guide, the term cannabiscannabis/hemp is inclusive of hemp plants
and derived products. This guide presents best laboratory practices, recommended certifications, recommended types of analyses
typically required in the cannabiscannabis/hemp industry, and recommended quality functions associated with laboratories
supporting the cannabiscannabis/hemp industry.
1.2 These recommendations establish a basis for oversight for the analytical testing of cannabis products. Developed
cannabis/hemp products. This guide was developed as a complement to existing good laboratory practices (GLP) andbest practices
and, in supporting conformance to current good manufacturing practices (GMP), which are typically required regulatory practices
relevant to the cannabis/hemp industries; these recommendations focus on the personnel, security, sample handling and disposal,
quality support, data management,management and reporting activities.
1.3 This guide generally describes the properties of cannabiscannabis/hemp, and cannabis-derivedcannabis/hemp/cannabis-hemp-
derived products to be analyzed and recommends the types of testing required.analyzed.
1.4 No recommendations found within this guide shall preclude observance of federal, state, or local regulations, regulations from
authorities having regional jurisdiction, which may be more restrictive or have different requirements.
1.5 This guide provides guidelines for compliance with good laboratory practices (GLP) and good manufacturing practices (GMP)
quality applications.laboratories supporting compliance GMP.
1.6 This guide applies to all cannabis-containing cannabis/hemp containing products commercially manufactured and distributed
for consumer use.
1.7 Units—The values stated in SI units are to be regarded as the standard. No other units of measurement are included in this
standard.
1.8 This guide does not purport to address all laboratory safety concerns associated with its use. It is the responsibility of the user
of this guide to establish appropriate safety and health practices, maintain all safety data sheets (SDS), and document safe
practices through work instructions and standard operating procedures (SOPs).
1
This guide is under the jurisdiction of ASTM Committee D37 on Cannabis and is the direct responsibility of Subcommittee D37.03 on Laboratory.
Current edition approved Oct. 1, 2020Jan. 15, 2021. Published October 2020February 2021. Originally approved in 2020. Last previous edition approved in 2020 as D8244
– 20. DOI: 10.1520/D8244-20.10.1520/D8244-21.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
D8244 − 21
1.9 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.
1.10 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.
2. Referenced Documents
2
2.1 ASTM Standards:
D8229 Guide for Corrective Action and Preventive Action (CAPA) for the Cannabis Industry
D8245 Guide for Disposal of Resin-Containing Cannabis Raw Materials and Downstream Products
D8270 Terminology Relating to Cannabis
D8282 Practice for Laboratory Test Method Validation and Method Development
3
2.2 ISO Standards:
ISO/IEC 17025:2017 General Requirements for the Competence of Testing and Calibration Laboratories
ISO 17034:2016 General Requirements for the Compet
...