Work Smarter, Not Harder: How ASTM Standards for Cannabinoids Improve Your Operations

David Vaillencourt, founder and CEO of The GMP Collective, Chairman of the Board for S3 Collective, and Vice-Chair of ASTM International Committee D37 on Cannabis Standards | Image Credit: © David Vaillencourt

The cannabis and hemp industry is ever-evolving, and staying compliant while ensuring product quality and safety is a top priority. For operators building toward long-term success, ASTM Standards bring much-needed clarity and consistency to the industry.

Solving the GMP Conundrum: ASTM D8557-24

One of the most significant challenges facing cannabis operators seeking Good Manufacturing Practices (GMP) certification is the absence of a clear, unified standard. The federal regulations currently offer three GMP classifications: Food, Pharmaceutical, and Dietary Supplements. However, due to the federal illegality of cannabis, none of these classifications are directly applicable to cannabis operations. This gap has led to a fragmented landscape of self-defined GMP schemes, causing confusion and inconsistency across the industry. ASTM is providing industry-specific solutions where the current lack of federal regulations have created gaps. This includes a solution, a cannabinoid GMP, that is agnostic to product type.

The newly approved ASTM D8557-24, Standard Guide for Good Manufacturing Practices (GMPs) for Cannabis/Hemp-Containing Edibles, Dietary Supplements, Topicals, and Inhaled Products, addresses this issue head-on. Led by Steven Gendel, PhD, this standard provides a comprehensive baseline for GMPs tailored specifically to the diverse range of cannabis products. It unifies the varying requirements and offers a clear framework for operators, helping to ensure consistent quality and safety across the board.

Bethany Moore, Director of Content Strategy and Market Growth, The GMP Collective | Image Credit: © Bethany Moore

Why This Standard Matters:

• Clarity and Consistency: Provides a single, standardized set of GMPs for all cannabis product types, reducing confusion and variability.
• Improved Compliance: Helps operators meet regulatory requirements more efficiently, paving the way for smoother certification processes.
• Enhanced Safety: Ensures that all cannabis products are produced under stringent quality controls, protecting consumer health and safety.

Elevating Quality Management: ASTM D8556-24

In conjunction with the new GMP standard, ASTM has introduced D8556-24, Standard Practice for Requirements of a Quality Management System for Cannabis and Hemp Operations. This standard outlines the essential requirements for establishing and maintaining a quality management system (QMS) that spans the entire operational lifecycle of cannabis and hemp products.

Ed Nodland, the ASTM cannabis committee membership secretary, who previously managed the Center for Process Learning at Boeing Commercial Airplanes and is now the co-founder of GapCross, an online quality management platform, led the development of D8556-24.

Reflecting on his work, Ed stated, ”In 2022, while developing an ASTM standards-based QMS audit program, I identified gaps in the existing collection of quality standards. Cary Black’s standard, D8222, provides a robust framework for establishing your QMS and details the necessary elements. Several other ASTM guides address specific quality elements, such as CAPA, recalls, management responsibilities, and supplier management, explaining why and how to implement each component. However, I sought a straightforward list that specified the minimal requirements for each element of a cannabis QMS.”

A well-implemented QMS is essential for maintaining high quality and safety standards across the cannabis industry. It ensures that every step—from cultivating raw materials to processing, manufacturing, final product testing, and distribution—adheres to rigorous quality controls. The D8556-24 standard provides the requirements for setting up and evaluating such a system specific to the cannabis sector.

Why This Standard Matters:

Comprehensive Quality Control: The standard establishes a holistic approach to quality management, ensuring that every operational stage is systematically covered.

Regulatory Alignment: D8556-24 helps operators align their processes with current and emerging regulations, significantly reducing the risk of non-compliance and associated penalties.

Operational Efficiency: By streamlining processes, the standard enhances overall operational efficiency, leading to cost savings and improved product quality.

Risk Mitigation: A well-structured QMS reduces the likelihood of errors that can lead to material waste, product recalls, regulatory fines, and staff frustration—factors that often contribute to higher employee turnover.

Bringing It All Together

These two new ASTM standards, D8556-24 and D8557-24, represent significant strides toward creating a more standardized and reliable framework for the cannabis and hemp industry. By providing clear guidelines for GMPs and QMS, they help operators ensure their products meet high quality and safety standards while simplifying the path to regulatory compliance.

The recent introduction of the Cannabis Standards and Regulations Act (CSRA) in the U.S. Senate further underscores the importance of implementing GMPs in cannabis and hemp operations. This bill, introduced by Sen. Wyden (D-OR), grants the FDA authority to enforce GMPs for all cannabinoid manufacturers, aiming to safeguard product safety and quality for consumers. Additionally, it introduces strict requirements for facility registration, product labeling, and inspections, further integrating compliance into the federal regulatory structure. The writing is on the wall: GMPs for cannabis are the future.

GMP (Good Manufacturing Practice) sets the essential standards for ensuring the safety of edible cannabis products by establishing guidelines that cover every aspect of production, from the cleanliness of facilities and equipment to the quality of raw materials and the training of personnel. These standards are critical for preventing contamination and ensuring that products are safe for consumption. Effectively implementing sustainable manufacturing practices, GMP, relies on a robust Quality Management System (QMS).

A QMS ensures that GMP, cultivation, or testing practices are established and consistently applied and maintained within the organization. This is achieved by defining clear policies that align with GMP, ensuring that production processes are reliable and adhere to safety standards, and documenting all procedures to ensure consistency and compliance. Additionally, QMS involves managing any changes to processes carefully, providing continuous training to staff to keep them informed about GMP standards, and maintaining thorough records to verify compliance with company policies and procedures.

Together, GMP and QMS create a comprehensive framework that safeguards the quality and safety of cannabis products, ensuring they reliably meet consumer expectations and regulatory requirements.

As we navigate the complexities of this rapidly growing industry, having well-defined standards is crucial. Standards not only protect consumers but also foster trust and credibility within the market. We encourage all industry stakeholders to familiarize themselves with these standards and consider their adoption to enhance their operations and contribute to a safer, more consistent industry landscape.

Stay tuned for more insights and updates on ASTM standards in our ongoing series. If you have any questions or need further information on these standards, feel free to reach out. Together, we can ensure that the cannabis and hemp industry continues to thrive on a foundation of quality and safety.

Contact Information:

For more information on these ASTM standards or to get involved in the standards development process, please visit www.astm.org or contact David Vaillencourt at The GMP Collective.

About the Authors

David Vaillencourt is the Founder and CEO of The GMP Collective where his team services the cannabis and life science industries with supply chain and operational best practices support from concept to consumer. David brings 15 years of experience in education, project management, and quality control work to the industry. He has served as an expert witness for hemp lawsuits, developed international consensus standards, and worked previously as the Director of Quality for a multi-state cannabis operator. Committed to advancing the industry through sound science and education, David serves as an Officer on ASTM International’s D37 Cannabis Committee, where he was recently awarded for his contributions in developing the first Laboratory Standard for Cannabis Test Method Validation. He also serves on the National Cannabis Industry Association’s Facility Design Committee. When not enjoying the 3 L’s of life, Leadership, Learning, and Listening, you can find him out in the mountains with his dog.

Bethany Moore is the Director of Content Strategy and Market Growth at The GMP Collective. She previously worked for nearly ten years at the National Cannabis Industry Association as Director of Communications, where she hosted NCIA’s Cannabis Industry Voice weekly podcast for many years. Bethany has extensive experience in nonprofit activism work, including drug policy reform and church-state separation issues. She has a strong background in project management and strategic planning, as well as communications and public relations. She enjoys writing, publishing, and performing poetry and playing pinball machines. Bethany is originally from the Washington, D.C., area and relocated to Denver in 2014.

References

1. National Cannabis Industry Association. Webinar: NCIA Service Solutions: Why Good Manufacturing Practices are Critical for Cannabis Edibles Success. February 2021.
2. National Cannabis Industry Association. Committee Blog: Facts About Current Good Manufacturing Practices (cGMPs) And Their Role In The Cannabis Industry. April 2020.
3. ASTM International D37 Committee. Standard Guide for Good Manufacturing Practices (GMPs) for Cannabis/Hemp-Containing Edibles, Dietary Supplements, Topicals, and Inhaled Products, 2024.https://doi.org/10.1520/D8557-24. DOI: 10.1520/D8557-24
4. ASTM International D37 Committee. Standard Practice for Requirements of a Quality Management System for Cannabis and Hemp Operations, 2024.https://doi.org/10.1520/D8556-24. DOI: 10.1520/D8556-24
5. Office of Senator Wyden (D-OR). Cannabinoid Safety and Regulation Act.
6. The GMP Collective. Blog: Navigating the Cannabinoid Safety and Regulation Act (CSRA): A Call to Action for Industry Standards. October 2024.