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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.,
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.
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 (TBT) Committee.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
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
ISO StandardsISO 17034:2016 General Requirements for the Competence of Reference Material Producers ISO/IEC 17025:2017 General Requirements for the Competence of Testing and Calibration Laboratories
Other StandardsILAC B7:10/2015 Mutual Recognition Arrangement (MRA) Available from International Laboratory Accreditation Cooperation (ILAC), the ILAC Secretariat, P.O. Box 7507, Silverwater NSW 2128, Australia, http://ilac.org.
|Link to Active (This link will always route to the current Active version of the standard.)|
ASTM D8244-21, Standard Guide for Analytical Laboratory Operations Supporting the Cannabis/Hemp Industry, ASTM International, West Conshohocken, PA, 2021, www.astm.orgBack to Top