1.1 本规程规定了质量管理体系（QMS）实施和监督的管理责任。它可以应用于所有大麻作业，包括种植、制造、贴标签、配药和分销。本实践并不涉及质量管理体系的细节，而是侧重于管理层在建立QMS中的作用的主要考虑因素。指导 D8222 提供QMS组件的概述和一些详细信息。其他标准提供了特定QMS组件的详细信息。 1.2 本实践中使用的术语GxP旨在将这些良好实践包括在 1.1 ; 即种植、制造、分销以及与这些活动相关的所有相关功能（例如，采购、测试、存储等）。 1.3 尽管该实践提到了健康和安全的重要性，但它是在全面管理责任的背景下进行的。该实践没有涉及健康和安全系统的细节，但它将其作为管理责任来确定。 1.4 该实践包括质量管理体系的单个组成部分（管理职责），当与其他要素结合时，满足完整质量管理体系的要求。 1.5 本标准中描述的做法旨在适用于大麻植物的所有产品，包括可归类为大麻的产品，其中包含大麻素，可通过口、鼻、皮肤（无论是否描述为药物、补充剂、食品、化妆品等）消费/摄入。 1.6 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。 1.7 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 本规程适用于任何大麻作业，作为健全质量管理体系（QMS）的基本部分。 4.2 监管机构可以利用这种做法制定法规，要求实施QMS原则，特别是管理层的角色和责任。此外，监管机构可以使用这种做法来帮助建立检查表，以评估管理层的参与度和对基于QMS的法规的遵守情况。 4.3 审计员将使用这种做法来评估管理层对运营QMS的参与程度。 4.4 任何已经实施或试图实施QMS的大麻作业都将使用这种做法。

1.1 This practice provides the management responsibilities for the implementation and oversight of a quality management system (QMS). It can be applied to all cannabis operations, including cultivation, manufacturing, labeling, dispensing, and distribution. This practice does not address the quality management system details, but rather focuses on the main considerations for management’s role in setting up a QMS. Guide D8222 provides an overview and some details about the components of a QMS. Other standards provide details on specific QMS components. 1.2 The term GxP as used in this practice is meant to include those good practices in the activities included in 1.1 ; namely cultivation, manufacturing, distribution, and all the relevant functions associated with these activities (for example, purchasing, testing, storing, and so forth). 1.3 Although this practice mentions the importance of health and safety, it is done so in the context of overall management responsibility. This practice does not address details of a health and safety system, but it identifies the importance of this as a management responsibility. 1.4 This practice encompasses a single component of the QMS (management responsibilities) that, when combined with the other elements, satisfies the requirements of a complete QMS. 1.5 The practices described in this standard are intended to apply to all products of a cannabis plant including those that can be classified as hemp and which contain cannabinoids and can be consumed/ingested via mouth, nose, skin (whether described as medicine, supplements, food, cosmetics, and so forth.). 1.6 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. 1.7 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 This practice is for any cannabis operation to use as a fundamental part of a robust quality management system (QMS). 4.2 Regulators can use this practice to develop regulations that require the implementation of QMS principles, specifically management’s role and responsibilities. Further, regulators can use this practice to help build a checklist to evaluate management’s engagement and compliance with QMS based regulations. 4.3 Auditors would use this practice to assess the level of management engagement with an operations QMS. 4.4 Any cannabis operation that has implemented or seeks to implement a QMS would use this practice.