Work Item
ASTM WK85656
New Guide for Good Manufacturing Practices (GMPs) for Cannabis/Hemp-Containing Products
1. Scope
This guide describes Good Manufacturing Practices (GMPs) for use by facilities that produce cannabis/hemp-containing products for human use. It is intended to apply to facilities that operate in jurisdictions without regulatory GMP requirements. Other guides will address GMPs for facilities that operate in jurisdictions with specific requirements.
This guide is applicable to entities involved in producing cannabis/hemp-containing products regardless of the type of plant, plant part, or derivative used. It applies to all aspects of production, including the use of non-cannabis/hemp ingredients, additives, or components.
This guide does not apply to cultivation, harvesting, or immediate post-harvest activities such as trimming and cleaning undesired plant parts. Guidance on good growth practices will be provided in a separate standard.
Keywords
Good Manufacturing Practice, GMP, Cannabis products, safety management, quality management
Rationale
To ensure that products containing cannabis/hemp-derived ingredients or components are safe for human use, it is imperative that production takes place in an environment that supports product safety and quality. Good Manufacturing Practices (GMPs) are the facility-specific practices and controls that are necessary to create this environment.
Currently, there are significant differences in the manufacturing requirements for cannabis/hemp-containing products in different jurisdictions. In some places, local regulations mandate adherence and refer to national regulations. Some jurisdictions have articulated specific requirements while others require adherence to GMPs without defining what this means. In addition, many jurisdictions have not addressed the need for GMPs. This makes it difficult for processors to understand how to develop and implement effective GMPs, creates challenges for regulatory authorities, and fosters consumer risk.
This standard guide describes a framework for GMPs that facilities can apply to the production of any type of cannabis/hemp-containing product in those jurisdictions where there are no actionable GMP requirements. Other standards will provide guidance on how to implement production controls in facilities that operate in jurisdictions that mandate adherence to specific national regulations. For facilities seeking certification under a private third-party system, this framework can be used to identify and correct gaps.
The title and scope are in draft form and are under development within this ASTM Committee.
Work Item Status
Date Initiated: 03-15-2023
Technical Contact: Steven Gendel