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

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.