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现行 IWA 37-3:2022
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Safety, security and sustainability of cannabis facilities and operations — Part 3: Good production practices (GPP) 大麻设施和运营的安全、安保和可持续性——第3部分:良好生产规范(GPP)
发布日期: 2022-10-11
本文件规定了直接或间接参与大麻供应链的组织的要求和建议,以使其能够: —?计划、实施、操作、维护和更新良好的生产实践方案,以根据预期用途提供安全的产品; —?证明符合适用的法律法规要求; —?评估和评估双方同意的客户要求,并证明符合这些要求; —?与相关方进行有效沟通,并证明符合相关相关方的要求; —?证明符合大麻质量计划(CQP)中关于产品安全、产品质量、产品安全和设施安全的规定政策; —?支持外部组织对质量计划的评估,或允许自我评估或自我声明遵守本文件中的部分或全部指导。 本文件中的所有要求都是通用的,旨在适用于大麻供应链中的所有组织,无论其规模和/或复杂性如何。直接或间接参与的组织包括(但不限于)种植者/耕种者、收割机、初级加工者、大麻生产者、大麻衍生物、大麻食用品和/或大麻产品制造商、测试供应商、提供运输、储存和分销服务的零售商和组织、设备供应商、,包装材料和其他接触材料。 本文件旨在使任何组织,包括小型和/或欠发达组织,能够在其CQP中实施外部开发的元素。 注释1大麻供应链中的组织性质多样,并非本文件中规定的所有要求都适用于每个机构或过程。排除或使用替代措施的理由可以通过风险评估/危害分析或其他适当手段进行记录。 本文件提供了与以下类别大麻、大麻衍生物和大麻产品相关的指导: —?大麻植物种子; —?大麻植物; —?新鲜大麻; —?干大麻; —?大麻衍生物; —?大麻专题; —?可吸入大麻。 注2附件B根据现行食品安全标准中的要求和建议,提供了将GPP应用于大麻食用食品的额外指导。 如果建筑物或场所将大麻植物的种植和加工(包括辅助活动)与其他经营活动结合起来,则本文件中的要求和建议仅适用于设施的该部分。 注释3如果共同建筑中存在联合使用活动,则每一类都可以适用特定的法律法规要求。 本文件未涉及以下内容: —?与成品研发活动相关的要求; —?一般防火或建筑施工特征,通常是当地建筑和消防规范(如适用)的功能; —?专门用于经营活动的场所,如办公场所、呼叫中心和零售点,用于大麻的分销、营销或销售; 注释4从生产设施装运和接收产品以供进一步分销不被视为零售店。 —?采用这些良好生产做法的组织生产的大麻或大麻产品的安全消费或使用; —?除A.8.4和A.8.6中规定的外,管制大麻工人和人员的职业健康和安全要求; —?环境保护; —?供应链监控系统的安全,包括网络安全和通知; 注释5供应链的安全和监控在IWA中有具体规定37-2. —?大麻和工业大麻的户外种植; —?种植供个人使用的大麻; —?使用大麻类化合物作为除大麻以外的植物、其他生物或人工合成的成分
This document specifies requirements and recommendations for organizations directly or indirectly involved in the cannabis supply chain, to enable them to: —?plan, implement, operate, maintain and update a good production practice programme for providing products that are safe, according to their intended use; —?demonstrate compliance with applicable statutory and regulatory requirements; —?evaluate and assess mutually agreed customer requirements and demonstrate conformity to them; —?effectively communicate with interested parties and demonstrate conformity to relevant interested parties; —?demonstrate conformity to stated policies in a cannabis quality programme (CQP) for product safety, product quality, product security and facility safety; —?support the evaluation of quality programmes by external organizations or to permit self-assessment or self-declaration of adherence to some or all of the guidance contained in this document. All requirements in this document are generic and intended to be applicable to all organizations in the cannabis supply chain, regardless of size and/or complexity. Organizations that are directly or indirectly involved include (but are not limited to) growers/cultivators, harvesters, primary processors, producers of cannabis, manufacturers of cannabis derivatives, cannabis edibles and/or cannabis products, testing providers, retailers and organizations providing transportation, storage and distribution services, suppliers of equipment, packaging materials and other contact materials. This document intended to enable any organization, including small and/or less developed organizations, to implement externally developed elements in its CQP. NOTE 1?Organizations in the cannabis supply chain are diverse in nature and not all the requirements specified in this document apply to each establishment or process. Justifications for exclusions or the use of alternative measures can be documented by a risk assessment/hazard analysis or other appropriate means. This document provides guidance related to the following categories of cannabis, cannabis derivatives and cannabis products: —?cannabis plant seeds; —?cannabis plants; —?fresh cannabis; —?dried cannabis; —?cannabis derivatives; —?cannabis topicals; —?inhalable cannabis. NOTE 2?Annex?B provides additional guidance on applying GPP to cannabis edibles with respect to requirements and recommendations in existing food safety standards. Where buildings or premises combine cultivation and processing of cannabis plants, including ancillary activities, along with other operational activities, the requirements and recommendations in this document apply only to that portion of the facility. NOTE 3?Where joint use activities are present in a common building, specific statutory and regulatory requirements can apply for each category. This document does not address the following: —?requirements related to research and development activities for finished products; —?general fire prevention or building construction features that are normally a function of local building and fire codes where applicable; —?premises used exclusively for operational activities, such as office space, call centres and retail outlets, used for the distribution, marketing, or sale of cannabis; NOTE 4?Shipping and receiving of products from the production facility for further distribution are not considered as a retail outlet. —?the safe consumption or use of the cannabis or cannabis products produced by organizations applying these good production practices; —?occupational health and safety requirements governing cannabis workers and personnel except as identified in A.8.4 and A.8.6; —?the protection of the environment; —?security of the supply chain monitoring system, including cybersecurity and notifications; NOTE 5?Security and monitoring of the supply chain are dealt with specifically in IWA?37-2. —?outdoor cultivation of cannabis and industrial hemp; —?growing of cannabis intended for personal use; —?the use of cannabinoids as ingredients that are derived from plants other than cannabis, or derived from other organisms, or created synthetically
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