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Standard Guide for Conducting Recall/Removal Procedures for Products in the Cannabis Industry 大麻工业产品召回/移除程序的标准指南
发布日期: 2020-04-15
1.1 本指南描述了与任何需要回收大麻衍生产品的事件相关的产品召回和移除/撤回的一般最佳做法行动计划。本指南适用于所有商业制造和分销供消费者使用的大麻衍生产品。本指南适用于供应商、消费者、零售商和分销商。具体的产品召回决定是不可接受的产品安全的结果,需要通知管理实体产品安全法律的适当政府机构。如果产品被认为不安全、品牌错误或掺假,监管机构希望召回该产品。这些管理机构在本指南中被称为监管机构。各种管辖监管机构可能有超出本指南建议范围的具体和额外召回要求。在这些情况下,必须遵守管理监管机构的要求。 本文件还提供了从市场上移除/撤回产品的一般指南。产品移除/撤回纯粹出于商业原因,通常与产品安全无关,不需要监管机构通知。产品移除/撤回的方式与产品召回的方式相同。本指南是作为最佳实践方法发布的,并不能取代绝对管辖权的监管要求。 1.2 以国际单位制表示的数值应视为标准值。本标准不包括其他计量单位。 1.3 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。 1.4 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 在本指南中,建议了有效开发、控制和管理程序和记录的步骤,这些程序和记录是有效产品召回/从市场上移除所需的。 4.2 本指南提供了一种系统的程序和文件方法,涉及因健康、安全或质量不合格而导致产品召回或从市场上撤下时所需采取的步骤。 4.3 本指南为进行模拟召回提供了程序基础,以评估组织现有可追溯性系统的有效性。
1.1 This guide describes the general best-practices action plan for conducting product recall and removal/withdrawal as related to any incident requiring the recovery of cannabis-derived products. This guide applies to all cannabis-derived products commercially manufactured and distributed for consumer use. This guide is for suppliers, consumers, retailers, and distributors. A specific product recall decision is the result of unacceptable product safety and requires notification of the appropriate governmental agencies governing the entity’s product safety laws. Governing regulatory agencies expect a product to be recalled if it is deemed to be unsafe, misbranded, or adulterated. These governing agencies are referenced as regulatory agencies throughout this guide. Various jurisdictional regulatory agencies may have specific and additional recall requirements falling beyond the recommendations of this guide. In these cases, the requirements of the governing regulatory agency must be followed. This document also provides general guidelines for the removal/withdrawal of products from the marketplace. Product removal/withdrawal is undertaken for purely commercial reasons that are typically unrelated to product safety and does not require regulatory agency notification. Product removal/withdrawal is carried out in the same manner as a product recall. This guide is being published as a best-practices approach and does not replace absolute jurisdictional regulatory requirements. 1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.3 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. 1.4 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 In this guide, steps are suggested for the effective development, control, and management of procedures and records required for an effective product recall/removal from the marketplace. 4.2 This guide presents a systematic approach to procedures and documentation regarding the steps necessary to be taken in the event of a product recall or removal from the marketplace because of health, safety, or quality nonconformances. 4.3 This guide provides a procedural basis for conducting a mock recall for purposes of evaluating the efficacy of an organization’s existing traceability systems.
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归口单位: D37.02
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