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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.,
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.
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.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
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.
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
|Link to Active (This link will always route to the current Active version of the standard.)|
ASTM D8244-20, Standard Guide for Analytical Laboratory Operations Supporting the Cannabis Industry, ASTM International, West Conshohocken, PA, 2020, www.astm.orgBack to Top