1.1 本指南为获得许可或以其他方式指定在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、推荐的大麻行业通常需要的分析类型，以及与支持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产品的分析测试奠定了基础。这些建议是对现有良好实验室规范（GLP）的补充，并支持符合当前良好生产规范（GMP），重点关注人员、安全、样品处理和处置、质量支持、数据管理和报告活动。 1.3 本指南概述了待分析大麻和大麻衍生产品的特性，并建议了所需的测试类型。 1.4 本指南中的任何建议均不得妨碍遵守联邦、州或地方法规，这些法规可能更具限制性或有不同的要求。 1.5 本指南提供了符合良好实验室规范（GLP）和良好生产规范（GMP）质量应用的指南。 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。 1.9 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 实验室是大麻行业运营和消费者安全与满意度的组成部分。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，概述为大麻行业及其许多产品提供支持的业务的最佳做法。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、GLP、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 建议大麻实验室人员在管理、质量保证、法规遵从性、质量控制和人员培训能力方面使用本指南。

1.1 This guide provides recommendations for a laboratory licensed or otherwise designated to provide analytical support within the cannabis 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. ====== 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. 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, 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.