1.1 本指南为获得许可或以其他方式指定在大麻/大麻行业内提供分析支持的实验室提供了建议。在本指南的范围内，大麻/大麻一词包括大麻植物和衍生产品。本指南介绍了最佳实验室实践、推荐认证、大麻/大麻行业通常需要的推荐分析类型，以及与支持大麻/大麻行业的实验室相关的推荐质量功能。 1.2 这些建议为监督大麻/大麻产品的分析测试奠定了基础。本指南是对现有最佳实践的补充，并支持符合当前良好生产规范（GMP），这些规范通常是与大麻/大麻行业相关的监管规范；这些建议侧重于人员、安全、样本处理和处置、质量支持、数据管理和报告活动。 1.3 本指南概述了大麻/大麻的特性，以及待分析的大麻/大麻/大麻衍生产品。 1.4 本指南中的任何建议都不应妨碍具有区域管辖权的机构遵守法规，这些法规可能更具限制性或具有不同的要求。 1.5 本指南为支持GMP合规性的实验室提供了指南。 1.6 本指南适用于所有商业制造和分销供消费者使用的含大麻/大麻的产品。 1.7 单位- 以国际单位制表示的数值应视为标准。本标准不包括其他计量单位。 1.8 本指南并非旨在解决与其使用相关的所有实验室安全问题。本指南的用户有责任制定适当的安全和健康实践，维护所有安全数据表（SDS），并通过工作说明和标准操作程序（SOP）记录安全实践。 1.9 本标准并非旨在解决与其使用相关的所有安全问题（如有）。本标准的用户有责任在使用前制定适当的安全、健康和环境实践，并确定监管限制的适用性。 1.10 本国际标准是根据世界贸易组织技术性贸易壁垒（TBT）委员会发布的《关于制定国际标准、指南和建议的原则的决定》中确立的国际公认标准化原则制定的。 ====意义和用途====== 4.1 实验室是大麻/大麻行业运营以及消费者安全和满意度的组成部分。标准化实验室实践在建立和证明产品安全、质量以及遵守管理产品质量和安全的法规方面发挥着关键作用。 4.2 本指南旨在供实验室使用，概述为大麻/大麻行业及其许多产品提供支持的最佳操作实践。本指南基于FOCUS（大麻统一标准基础）和AHPA（美国草药产品协会）标准以及GMP合规指南中阐述的最佳实践。 5. , 6. 4.3 本指南的内容反映了不同实验室监管指南施加的典型要求。它为实验室操作、GMP、人员能力、能力验证、设施操作、安全、样品转移和接收、样品处理和处置、设备和试剂注意事项、参考标准、分析程序、数据处理和处理、质量保证、可追溯性和认证建议提供了建议。 4.4 建议参与大麻/大麻实验室操作的大麻/大麻实验室人员使用本指南。

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. ====== 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.