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ASTM D8244-20

(Guide)

Standard Guide for Analytical Laboratory Operations Supporting the Cannabis Industry

Standard Guide for Analytical Laboratory Operations Supporting the Cannabis Industry

SIGNIFICANCE AND USE
4.1 Laboratories are integral to cannabis 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 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, GLP, 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 laboratory personnel in management, quality assurance, regulatory compliance, quality control, and personnel training capacities.
SCOPE
1.1 This guide provides recommendations for a laboratory licensed or otherwise designated to provide analytical support within the cannabis industry. Within the scope of this guide, the term cannabis 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 industry, and recommended quality functions associated with laboratories supporting the cannabis industry.  
1.2 These recommendations establish a basis for oversight for the analytical testing of cannabis products. Developed as a complement to existing good laboratory practices (GLP) and supporting conformance to current good manufacturing practices (GMP), 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 and cannabis-derived products to be analyzed and recommends the types of testing required.  
1.4 No recommendations found within this guide shall preclude observance of federal, state, or local regulations, 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.  
1.6 This guide applies to all cannabis-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 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.  
1.9 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

Status
Historical
Publication Date
30-Sep-2020
ICS
71.040.10 - Chemical laboratories. Laboratory equipment
Technical Committee
D37 - Cannabis
Drafting Committee
D37.03 - Laboratory
Current Stage
Ref Project

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ASTM D8244-20 - Standard Guide for Analytical Laboratory Operations Supporting the Cannabis IndustryASTM D8244-20 - Standard Guide for Analytical Laboratory Operations Supporting the Cannabis Industry
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ASTM D8244-20 - Standard Guide for Analytical Laboratory Operations Supporting the Cannabis Industry
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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 − 20
Standard Guide for
Analytical Laboratory Operations Supporting the Cannabis
1
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 priate safety, health, and environmental practices and deter-
mine the applicability of regulatory limitations prior to use.
1.1 This guide provides recommendations for a laboratory
1.9 This international standard was developed in accor-
licensed or otherwise designated to provide analytical support
dance with internationally recognized principles on standard-
withinthecannabisindustry.Withinthescopeofthisguide,the
ization established in the Decision on Principles for the
termcannabisisinclusiveofhempplantsandderivedproducts.
Development of International Standards, Guides and Recom-
This guide presents best laboratory practices, recommended
mendations issued by the World Trade Organization Technical
certifications, recommended types of analyses typically re-
Barriers to Trade (TBT) Committee.
quired in the cannabis industry, and recommended quality
functions associated with laboratories supporting the cannabis
2. Referenced Documents
industry.
2
2.1 ASTM Standards:
1.2 These recommendations establish a basis for oversight
D8282 Practice for Laboratory Test Method Validation and
for the analytical testing of cannabis products. Developed as a
Method Development
complement to existing good laboratory practices (GLP) and
3
2.2 ISO Standards:
supporting conformance to current good manufacturing prac-
ISO/IEC 17025:2017 General Requirements for the Compe-
tices (GMP), these recommendations focus on the personnel,
tence of Testing and Calibration Laboratories
security, sample handling and disposal, quality support, data
ISO 17034:2016 General Requirements for the Competence
management, and reporting activities.
of Reference Material Producers
1.3 This guide generally describes the properties of canna-
2.3 Other Standards:
bis and cannabis-derived products to be analyzed and recom-
ILAC B7:10/2015 Mutual Recognition Arrangement
4
mends the types of testing required.
(MRA)
1.4 No recommendations found within this guide shall
3. Terminology
preclude observance of federal, state, or local regulations,
3.1 Definitions of Terms Specific to This Standard:
which may be more restrictive or have different requirements.
3.1.1 cannabis, n—a genus of flowering plants within the
1.5 This guide provides guidelines for compliance with
Cannabaceae family identified by their distinctive glandular
good laboratory practices (GLP) and good manufacturing
trichomes, divided serrated leaves, and tough bast fibers.
practices (GMP) quality applications.
3.1.1.1 Discussion—In this guide, the term cannabis is used
1.6 This guide applies to all cannabis-containing products
to refer to cannabis raw material that includes resin cannabis,
commercially manufactured and distributed for consumer use.
nutritional cannabis, that includes hemp, in a harvested raw
material form.
1.7 Units—The values stated in SI units are to be regarded
3.1.2 cannabis-derived product, n—aproduct,otherthanthe
as the standard. No other units of measurement are included in
cannabis plant itself, which contains or is derived from
this standard.
cannabis or hemp by manufacturing as defined.
1.8 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 guide is under the jurisdiction ofASTM Committee D37 on Cannabis and Available from American National Standards Institute (ANSI), 25 W. 43rd St.,
is the direct responsibility of Subcommittee D37.03 on Laboratory. 4th Floor, New York, NY 10036, http://www.ansi.org.
4
Current edition approved Oct. 1, 2020. Published October 2020. DOI: 10.1520/ AvailablefromInternationalLaboratoryAccreditationCooperation(ILAC),the
D8244-20. ILAC Secretariat, P.O. Box 7507, Silverwater NSW 2128,Australia, http://ilac.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
D8244 − 20
3.1.3 controlled area, n—an area to which access is physi- rangement (MRA) (ILAC B7:10/2015) or an equivalent na-
cally limited to protect individuals or
...

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SIGNIFICANCE AND USE
5.1 The sample preparation procedure for comminution impacts other downstream processes such as extraction and sonication, which ultimately affects the total analytical error (TAE) and measurement uncertainty.  
5.2 Factors that may influence the sample preparation process include the prevention of cross-contamination (carryover) from a prior sample and an inadequate cleaning procedure between preparation of samples, poor sample handling, storage (sample preservation), and moisture content (drying methods) of plant material being greater than 15 % (15). Samples with high moisture content are hard to process completely and may yield lower analyte (that is, cannabinoid) concentration during extraction and further processing. Lastly, water activity Specification D8197 is recommended, activity (aw) range (0.55 to 0.65) for dry cannabis or hemp flower or both.  
5.3 There are many different types of hardware technologies that address the comminution of dried cannabis or hemp; however, the list of devices is exhaustive and thus beyond the scope of this guide. See Table 3 and Table 4  (16-18) for a summary of different milling technologies. Distinctions among various pieces of equipment often relate to the type, mass, and size/shape of the sample (dry, fibrous) for which each is most effective. In addition, there may be economic reasons for mill selection, that is, the sample throughput of the testing laboratory (number of samples per day), access to cryogenics, and sample mass requirements.    
5.4 In addition to sampling devices, this guide does not include the sample preparation of edibles, tinctures, oils/concentrates, beverages, and so forth in which the sample diversity poses significant sample preparation challenges to be put forward in additional work items.  
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1.1 In this guide, the basic steps in obtaining a test portion sample of either dried cannabis/hemp inflorescence are outlined.  
1.2 Sample preparation depends on many factors including moisture (dryness) of the sample, the analyte to be measured, the concentrations/amounts, and the test method's precision and accuracy requirements. In this case, dried cannabis or hemp plant material require particle size reduction-comminution from a representative sample of which the final analytical testing portion is determined by the employed testing method. Local regulatory guidelines often dictate both the representative sample that is taken from the bulk material (harvest batch) and the final mass of the test portion (for example  
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1.4 Units—The values stated in SI units are to be regarded as the standard. No other units of measurement are included in this standard.  
1.5 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.  
1.6 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.

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ASTM D8244-21a(Guide)
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.
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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 applies to all cannabis/hemp containing products commercially manufactured and distributed for consumer use.  
1.6 Units—The values stated in SI units are to be regarded as the standard. No other units of measurement are included in this standard.  
1.7 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).  
1.8 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.  
1.9 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.

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ASTM D8334/D8334M-20(Practice)
Standard Practice for Sampling of Cannabis/Hemp Post-Harvest Batches for Laboratory Analyses

SIGNIFICANCE AND USE
5.1 This standard will provide best practices for the sampling of harvested cannabis inflorescence with the intent to assure representative sampling.  
5.2 The laboratory results and their respective harvest batch associations have implications and significance to regulatory requirements, quality control considerations throughout the product’s life cycle, and the safety of the consumers who may be adversely affected by consumption of product that was not tested in a homogeneous manner (3).  
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1.1 Cannabis harvested materials require sampling strategies throughout their life cycle, from cultivation to the end consumer. For purposes of this standard, the term cannabis is inclusive of all cannabis inflorescence, including hemp varieties. The qualitative and quantitative characteristics of cannabis/hemp for human or animal consumption has safety implications throughout the life cycle from cultivation to end consumer. This standard provides best practice procedures and protocols for sampling batches of harvested cannabis inflorescence. Cannabis/hemp materials often exhibit variability across different parts within the same plant or across different plants within the same cultivar, or both, (1, 2).2 Thus, sampling strategies are required which yield a representative a sample across a harvest batch. Representative sampling is required to ensure that the qualitative and quantitative test results accurately reflect cannabinoid identification, potency, identification and concentration of terpenes, concentration of trace metals, microbiological activity, mycotoxins, and concentration of pesticides across the batch.  
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1.3 Units—The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system are not necessarily exact equivalents; therefore, to ensure conformance with the standard, each system shall be used independently of the other, and values from the two systems shall not be combined.  
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Standard Guide for Sample Preparation of Cannabis and Hemp Inflorescence for Laboratory Analysis

SIGNIFICANCE AND USE
5.1 The sample preparation procedure for comminution impacts other downstream processes such as extraction and sonication, which ultimately affects the total analytical error (TAE) and measurement uncertainty.  
5.2 Factors that may influence the sample preparation process include the prevention of cross-contamination (carryover) from a prior sample and an inadequate cleaning procedure between preparation of samples, poor sample handling, storage (sample preservation), and moisture content (drying methods) of plant material being greater than 15 % (15). Samples with high moisture content are hard to process completely and may yield lower analyte (that is, cannabinoid) concentration during extraction and further processing. Lastly, water activity Specification D8197 is recommended, activity (aw) range (0.55 to 0.65) for dry cannabis or hemp flower or both.  
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1.1 In this guide, the basic steps in obtaining a test portion sample of either dried cannabis/hemp inflorescence are outlined.  
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1.3 This guide will not purport to meet every local and state jurisdiction since different regulatory requirements vary; the local/state requirements are at the discretion of the user to follow and interpret.  
1.4 Units—The values stated in SI units are to be regarded as the standard. No other units of measurement are included in this standard.  
1.5 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.  
1.6 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.

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Standard Practice for Evaluation of Laboratories Testing Hydraulic Cement

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4.1 The testing of hydraulic cement is an important element in obtaining quality construction. A testing laboratory must be selected with care.  
4.2 A testing laboratory shall be deemed qualified to perform and report the results of its tests if the laboratory meets the requirements of this practice.  
4.3 This practice provides guidance for evaluating the organization, personnel, facilities, and quality systems of the laboratory. This practice may be supplemented by criteria and requirements for particular projects.
SCOPE
1.1 This practice covers the technical training and experience of laboratory testing personnel and identifies the minimum technical requirements for laboratory equipment used in testing of hydraulic cement as prescribed by ASTM.  
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SIGNIFICANCE AND USE
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4.3 This guide is not intended to be used as a tool to qualify or accredit laboratories to perform any tests. Refer to ISO/IEC 17025 and to the A2LA R101 Document for further guidance on accreditation requirements.
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1.1 This guide provides a general outline, for use by a laboratory monitor, to assess the qualifications of a laboratory that has requested to participate in a specific ASTM interlaboratory test.  
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1.6 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.

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Standard Practice for Cleaning Glass and Plastic Labware Used in Metal and Metalloid Analyses

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5.1 This practice is intended for use in laboratories using labware for the preparation and analysis of samples collected for analysis for metals or metalloids, or both.
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