ASTM International Standard Guide for Good Manufacturing Practices (GMPs) for Cannabis/Hemp-Containing Edibles, Dietary Supplements, Topicals, and Inhaled Products ASTM D8557-24

Description
1.1 This guide describes Good Manufacturing Practices (GMPs) for use by facilities that produce cannabis/hemp-contai ning edibles, dietary supplements, topicals, and inhaled products for human use. It applies to facilities that operate in jurisdictions without actionable regulatory GMP requirements, to all aspects of manufacturing, including the use of non-cannabis/hemp ingredients, additives, or components, and regardless of which plant part or derivative is used. 1.2 Other guides will address GMPs for facilities that operate in jurisdictions with specific requirements for manufacturing these products or other types of cannabis/hemp-contai ning products such as for veterinary use. 1.3 This guide does not apply to cultivation, harvesting, or immediate post-harvest activities such as trimming, cleaning undesired plant parts, drying, and curing. Guidance on Good Cultivation Practices will be provided in a separate standard. 1.4 This guide does not apply to products or ingredients that have been approved by a regulatory authority for use as food ingredients, dietary ingredients, or drug substances (for example, hemp seeds as a food ingredient), and are produced within the scope of that approval. 1.5 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. 1.6 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.
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Description
1.1 This guide describes Good Manufacturing Practices (GMPs) for use by facilities that produce cannabis/hemp-contai ning edibles, dietary supplements, topicals, and inhaled products for human use. It applies to facilities that operate in jurisdictions without actionable regulatory GMP requirements, to all aspects of manufacturing, including the use of non-cannabis/hemp ingredients, additives, or components, and regardless of which plant part or derivative is used. 1.2 Other guides will address GMPs for facilities that operate in jurisdictions with specific requirements for manufacturing these products or other types of cannabis/hemp-contai ning products such as for veterinary use. 1.3 This guide does not apply to cultivation, harvesting, or immediate post-harvest activities such as trimming, cleaning undesired plant parts, drying, and curing. Guidance on Good Cultivation Practices will be provided in a separate standard. 1.4 This guide does not apply to products or ingredients that have been approved by a regulatory authority for use as food ingredients, dietary ingredients, or drug substances (for example, hemp seeds as a food ingredient), and are produced within the scope of that approval. 1.5 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. 1.6 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.
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Standard Guide for Good Manufacturing Practices (GMPs) for Cannabis/Hemp-Containing Edibles, Dietary Supplements, Topicals, and Inhaled Products - ASTM D8557-24 - ASTM International
West Conshohocken, PA, United States
Standard Guide for Good Manufacturing Practices (GMPs) for Cannabis/Hemp-Containing Edibles, Dietary Supplements, Topicals, and Inhaled Products
ASTM D8557-24
Standard Guide for Good Manufacturing Practices (GMPs) for Cannabis/Hemp-Containing Edibles, Dietary Supplements, Topicals, and Inhaled Products ASTM D8557-24
1.1 This guide describes Good Manufacturing Practices (GMPs) for use by facilities that produce cannabis/hemp-contai ning edibles, dietary supplements, topicals, and inhaled products for human use. It applies to facilities that operate in jurisdictions without actionable regulatory GMP requirements, to all aspects of manufacturing, including the use of non-cannabis/hemp ingredients, additives, or components, and regardless of which plant part or derivative is used. 1.2 Other guides will address GMPs for facilities that operate in jurisdictions with specific requirements for manufacturing these products or other types of cannabis/hemp-contai ning products such as for veterinary use. 1.3 This guide does not apply to cultivation, harvesting, or immediate post-harvest activities such as trimming, cleaning undesired plant parts, drying, and curing. Guidance on Good Cultivation Practices will be provided in a separate standard. 1.4 This guide does not apply to products or ingredients that have been approved by a regulatory authority for use as food ingredients, dietary ingredients, or drug substances (for example, hemp seeds as a food ingredient), and are produced within the scope of that approval. 1.5 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. 1.6 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.

1.1 This guide describes Good Manufacturing Practices (GMPs) for use by facilities that produce cannabis/hemp-containing edibles, dietary supplements, topicals, and inhaled products for human use. It applies to facilities that operate in jurisdictions without actionable regulatory GMP requirements, to all aspects of manufacturing, including the use of non-cannabis/hemp ingredients, additives, or components, and regardless of which plant part or derivative is used.


1.2 Other guides will address GMPs for facilities that operate in jurisdictions with specific requirements for manufacturing these products or other types of cannabis/hemp-containing products such as for veterinary use.


1.3 This guide does not apply to cultivation, harvesting, or immediate post-harvest activities such as trimming, cleaning undesired plant parts, drying, and curing. Guidance on Good Cultivation Practices will be provided in a separate standard.


1.4 This guide does not apply to products or ingredients that have been approved by a regulatory authority for use as food ingredients, dietary ingredients, or drug substances (for example, hemp seeds as a food ingredient), and are produced within the scope of that approval.


1.5 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.


1.6 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.

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  ASTM International
Product Category Standards and Technical Documents
Product Number ASTM D8557-24
Product Name Standard Guide for Good Manufacturing Practices (GMPs) for Cannabis/Hemp-Containing Edibles, Dietary Supplements, Topicals, and Inhaled Products
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