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Standard Guide for Analytical Laboratory Operations Supporting the Cannabis/Hemp Industry (Includes all amendments and changes 6/18/2021).
NORMA vydaná dňa 1.6.2021
Označenie normy: ASTM D8244-21a
Dátum vydania normy: 1.6.2021
Kód tovaru: NS-1029211
Počet strán: 6
Približná hmotnosť: 18 g (0.04 libier)
Krajina: Americká technická norma
Kategória: Technické normy ASTM
analyses, calibrations, cannabis, chain of custody, compliance, data, GMP, hemp, hemp products, laboratory, maintenance, marijuana, recording, regulations, samples, security, SOPs, validation,
|Significance and Use|
4.1Laboratories 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.
4.2This 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.,
4.3The 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.
4.4This guide is recommended for use by cannabis/hemp laboratory personnel involved in cannabis/hemp laboratory operations.
1.1This 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.
1.2These 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.
1.3This guide generally describes the properties of cannabis/hemp, and cannabis/hemp/cannabis-hemp-derived products to be analyzed.
1.4No recommendations found within this guide shall preclude observance of regulations from authorities having regional jurisdiction, which may be more restrictive or have different requirements.
1.5This guide applies to all cannabis/hemp containing products commercially manufactured and distributed for consumer use.
1.6UnitsThe values stated in SI units are to be regarded as the standard. No other units of measurement are included in this standard.
1.7This 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).
1.8This 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.
1.9This 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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