ASTM D8244-21a

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 − 21 D8244 − 21a
Standard Guide for
Analytical Laboratory Operations Supporting the Cannabis/
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 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.
1.5 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.
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 Jan. 15, 2021June 1, 2021. Published February 2021June 2021. Originally approved in 2020. Last previous edition approved in 20202021 as
D8244 – 20.21. DOI: 10.1520/D8244-21.10.1520/D8244-21A.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
D8244 − 21a
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.
2. Referenced Documents
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
D8334 Practice for Sampling of Cannabis/Hemp Post-Harvest Batches for Laboratory Analyses
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 Competence of Reference Material Producers
2.3 Other Standards:
ILAC B7:10/2015 Mutual Recognition Arrangement (MRA)
3. Terminology
3.1 Definitions:
3.1.1 For definitions of terms used in this standard, refer to Terminology D8270.
3.2 Definitions of Terms Specific to This Standard:
3.2.1 cannabis/hemp-derived product, n—a product, other than the cannabis/hemp plant itself, which contains or is derived from
cannabis/hemp by manufacturing as defined.
3.2.2 equipment, n—non-expendable, tangible moveable property needed for the performance of a task or useful in effecting an
obligation.
3.2.3 instrument, n—equipment capable of performing measurements used to generate analytical data (for example, GCMS, IR,
NMR, balances, etc.).
3.2.4 laboratory information management system (LIMS), n—software that facilitates the management of laboratory samples and
associated data.
3.2.5 primary reference standard, n—an ultra-high purity grade a compound used in analysis involving assay, identification, or
purity tests. It can be a single compound or a mixture having the analyte of interest in a precisely specified and certified amount.
3.2.6 secondary reference standard, n—a reference standard whose purity is established by assaying it against a primary reference
standard.
3.2.7 test sample, n—the specific portion of cannabis/hemp raw materials or cannabis/hemp-derived products submitted for
analysis.
3.3 Acronyms:
3.3.1 COA, n—certificate of analysis
3.3.2 SOPs, n—standard operating procedures
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.
Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.
Available from International Laboratory Accreditation Cooperation (ILAC), the ILAC Secretariat, P.O. Box 7507, Silverwater NSW 2128, Australia, http://ilac.org.
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4. 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
, 6
guidelines.
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.
5. Laboratory Guidelines
5.1 Laboratories involved in the analyses of cannabis/hemp raw materials or cannabis/hemp-derived products, or both, should
incorporate SOPs, work instructions, forms, logs and specifications for the analytical tests conducted and related handling and
tracking of cannabis/hemp raw materials, and cannabis/hemp-derived products.
5.2 Laboratories should be accredited to ISO/IEC 17025:2017, or demonstrate conformance to the requirements for the
competence of testing and calibration laboratories, by an accreditation body who is a signatory to the International Laboratory
Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA) (ILAC B7:10/2015) or an equivalent nationally or
internationally recognized laboratory quality management standard.
5.3 Testing of cannabis/hemp or cannabis/hemp-derived products may include, among other things, analysis for:
5.3.1 Identification of cannabinoids and terpenoids (as required);
5.3.2 Potency (concentration of cannabinoids and terpenes);
5.3.3 Potential contaminants, such as analysis of:
5.3.3.1 Heavy metals;
5.3.3.2 Microorganisms or mycotoxins;
5.3.3.3 Residues of pesticide or plant growth regulators;
5.3.3.4 Residual solvents; and
5.3.3.5 Foreign matter.
5.3.4 Other quality factors, such as weight loss on drying, ash, acid, insoluble ash, water activity, and general conformity to
contractual specifications.
5.4 Analytical testing of cannabis/hemp-derived products may also include:
Recommendations for Regulators, Cannabis Operations; American Herbal Products Association (AHPA), February, 2016; Cultivation and processing operations
(Revision 2); Manufacturing and related operations (Revision 1); Laboratory operations (Revision 2); and Dispensing operations (Revision 4), available from American Herbal
Products Association (AHPA), 8630 Fenton St., #918, Silver Spring, MD 20910, http://www.ahpa.org.
Extraction/Infused Products, December 2016, V.1, available from Foundation of Cannabis Unified Standards (FOCUS), 4400 N. Scottsdale Rd., Suite 269, Scottsdale,
AZ 85251, http://www.focusstandards.org.
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5.4.1 Determination of composition or nutritional content; and
5.4.2 Other analyses as deemed appropriate or necessary.
5.5 Laboratory operations may utilize any appropriate and validated test methods and examinations in their analyses, including:
5.5.1 Gross organoleptic (sensory) analysis;
5.5.2 Macroscopic evaluation;
5.5.3 Microscopic analysis; and
5.5.4 Chemical analysis; and
5.5.5 ChemicalMicrobial analysis.
6. Personnel Guidelines
6.1 For all personnel engaged in a laboratory operation, the laboratory management should:
6.1.1 Complete personnel background checks based upon local or regional jurisdictional requirements; and
6.1.2 Assure that laboratory operations management provide education, training documentation, and experience, or any
combination thereof, required to competently perform all assigned functions;
6.1.3 Maintain personnel training records of any training and certifications received for the performance of all assigned functions;
and
6.1.4 Demonstrate personnel proficiency through timely proficiency assessments.
6.1.5 Provide and document safety, hazard training, and environmental response training.
6.2 Laboratory operations management should provide training and documentation for all personnel that includes:
6.2.1 Information on applicable local, regulatory, and governmental policies relating to individuals employed in these operations,
and the implications of these for such personnel.
6.2.2 Instructions regarding regulatory inspection preparedness.
6.2.3 The importance of following SOPs; and
6.2.4 Protocols and procedures for improvement and change control (management of change) of the SOPs, policies, and work
instructions.
6.2.5 The importance of maintaining timely, accurate, complete, and secure records.
6.2.6 All records should be governed by internal document control SOPs.
7. Physical Plant (Facilities)
7.1 All laboratory facilities that comprise analytical laboratory operations supporting the cannabis/hemp industry should:
7.1.1 Operate in compliance with all relevant local, regional, or national regulations, including, but not limited to the following:
7.1.1.1 Locations and zoning;
7.1.1.2 Business hours;
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7.1.1.3 Parking;
7.1.1.4 Cleanliness, sanitation, and maintaining an orderly condition; and
7.1.1.5 Location and function of appropriate safety tools (eye wash stations, safety showers, first aid and alarm usage and
documented response protocol).
7.1.2 Demonstrate environmental control over the laboratory facility to include compliance to regulatory requirements:
7.1.2.1 Contaminant minimization using pressure differential driven flow control (where necessary);
7.1.2.2 Air handling;
7.1.2.3 Hoods;
7.1.2.4 Solvent/chemical storage conditions meeting regulatory compliance;
7.1.2.5 Sample and retain storage;
7.1.2.6 Water treatment (where applicable);
7.1.2.7 Waste storage and segregation; and
7.1.2.8 Waste disposal (following jurisdictional regulatory requirements).
7.1.3 Be equipped with such utensils and equipment as are necessary to conduct all operations that occur at the laboratory facility;
and
7.1.4 Provide adequate space for laboratory operations, sample storage, and records and document storage to enable maintaining
a clean, sanitary, and safe working environment.
8. Security
8.1 Laboratory operations that handle cannabis/hemp and cannabis/hemp-derived test samples should establish and adhere to
security procedures that comply with applicable local and regional regulations or in compliance to the governing regulatory
documentation (whichever is more stringent).
8.2 Laboratory operations should:
8.2.1 Establish SOPs for all security practices, train all personnel, and retain training records reflecting each employee’s
understanding of the security procedures;
8.2.2 Provide security resources as needed to protect the personnel during working hours and in a manner appropriate for the
community where it operates;
8.2.3 Provide training to make all personnel aware of the operation’s security procedures, and each individual employee’s security
roles and responsibilities; and
8.2.4 Ensure that all laboratory operations analyzing cannabis/hemp be equipped with one or more controlled access areas for
storage in compliance with local or regional regulations for storage of the following:
8.2.4.1 Cannabis/hemp raw materials or cannabis/hemp-derived test samples, or both;both, as required by local jurisdictions;
8.2.4.2 Cannabis/hemp resin waste; and
8.2.4.3 Reference standards for analysis of controlled substances (as required by local or regional jurisdictions and manufacturer
recommendations).jurisdictions).
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8.2.5 Limit authorization to access controlled areas to select personnel and authenticate access to controlled areas by at least one,
or a combination of the following:
8.2.5.1 Locks;
8.2.5.2 Security guards;
8.2.5.3 Electronic badge readers; or
8.2.5.4 Biometric identifiers, or other means.
8.2.6 Take appropriate steps to ensure access privileges to the laboratory facility and to controlled access areas, as applicable, are
revoked for personnel who are no longer employed by the operation.
8.2.7 Take appropriate action where security personnel credentialing is lost or failures in proficiency testing are documented.
9. Sample Receipt
9.1 Laboratory operations may receive test samples from any compliant operation, or compliant individual or may be contracted
to collect test samples on behalf of those entities, if applicable and allowed by local or regional authorities. authorities (see Practice
D8334).
9.2 Laboratory operations should inform each compliant operation and compliant individual, or cultivator that submits test
samples of the following:
9.2.1 If the laboratory is actually collecting the test samples, they should ensure that the p
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