What is ASTM?

ASTM International is a Standards Organization that generates internationally accepted standards for multitude of industrial and consumer products. Without standards, Industries are left to market forces, and without collaboration, the industries fail to realize the full market potential. Reaching international markets requires standardization and ensuring social equity for manufacturing.

Why is ASTM dabbling in Cannabis?

ASTM International D37 Cannabis Standards Committee provides the opportunity for all cannabis and hemp industry stakeholders to collaboratively write standards for the manufacturing of cannabis. To date, there is no internationally recognized standard, as there are for pharmaceutical substances. However, several independent consensus standards, such as the Americans for Safe Access, American Herbal Products Association, Foundation for Unified Cannabis Standards, and Patient Focused Certification have contributed their standards for the baseline of cannabis and hemp specific Good Manufacturing Practices.

Competition vs Collaboration.

The United States has 3 major car manufacturers, whereas Japan has 6. This did not happen by accident. The Japanese auto manufacturers standardized their industry through collaborative efforts. Collaboration caused the Japanese to reach international markets, well beyond their own borders, dropping the concept of competition in order to reduce the overall cost of research and development. The United States auto manufacturers did not collaborate and instead worked on solving the same research and development problems internally. While there are many variables to the two respective nations profitability and market share in automotive manufacturing, the graph sourced the Economic Policy Institute below shows the trends – the Japanese manufacturers are increasing their market share.


How is it that the island nation of Japan is able to approach the market share levels of US manufacturers, inside the United States? It’s because the collaborated! If they had only competed, there would be far fewer remaining. Meanwhile, there is fierce competition between US manufacturers, and the opportunity to collaborate has far past.

Collaboration in Cannabis Standardization.

The case for Cannabis Standardization is not different. We have the opportunity to work collaboratively on an international level, and set standards that ensure the industry can self-regulate for all of its market segments. Without collaboration, we will be speaking different languages in regard to Cannabis Manufacturing Standards. International fair trade of products can only happen when all stakeholders are represented and ensure social equity is a primary consideration.

Inclusion and Social Equity.

To achieve goals of inclusion and social equity, stakeholders need to look to the commonalities between their manufacturing, before they look for differences. How can Sub-Saharan African farmers that have a specific climate and growing environment that produces low variation between plant populations, and Pharmaceutical Companies seeking the low variation raw materials from a single origin source work together…? With Standards!

Japanese auto manufactures have mastered collaboration on the national level, standardizing common needs in manufacturing within their country. ASTM D37 Cannabis Standards Committee Stakeholders have the opportunity to collaborate on an international level. We can work together, standardizing the common needs in manufacturing together, and gain an increased market share for all stakeholders.

Join ASTM D37 Cannabis Standards Committee!

Make you voice heard, become a stakeholder of ASTM International D37 Cannabis Standards Committee, and take part in building cannabis manufacturing standards that will impact international history.

Vetting your Vendors is key to consistent Product Quality.

All materials or services from vendors must be vetted to ensure all activities and purchased product qualities meet appropriate pre-defined specifications. Botanically derived nutritional and dietary supplements are notorious for having variation, and vendors will ofter shirk their responsibility to confirm the Critical Quality Attributes of the materials they are selling. This puts the onus on the manufacturer to ensure their raw materials are qualified for use. All such vetting processes are risk management activities, where risks are weighed to ensure final product quality specifications will not be compromised.

Vendor Auditing.

Vendor auditing should occur to ensure suppliers and service providers are competent to fulfill their roles and provide materials in a fully characterized supply chain. Periodic vendor audits should be performed to ensure all agreements and specifications are met, and that product quality is continuously improved. All materials and services provided by vendors should be monitored for meeting quality specifications, managing risks to final product quality.

Vendor Agreements.

It is wise to have a vendor agreement that establishes the responsibility of the vendor to supply raw materials that meet the specifications your organization has set. This is a huge topic that is often glanced over, as we have observed in countless GMP audits in the pharmaceutical, nutritional and dietary supplement, cannabis, and cosmetics industries. Choose one quality vendor that consistently supplies high quality materials, and build a good relationship with them. Ultimately, Vendor Agreements are the art of relationship management in manufacturing. Choose your vendors wisely, treat them well, and they should do the like in return.

Action you can take:

Make a list of all the raw materials used in your manufacturing operation. Identify which vendors are supplying raw materials that are critical to product quality. Rank the raw materials by the relative risk they pose if they do not meet specifications. Then talk to to your vendors. Ask them about variation in their supply chains, and find the right vendor for the raw materials. Put effort into building your vendor relationships, and your product quality will grow in proportion.

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Continuous Improvement is the goal of every Quality Brand.

Products generally go through a 4 stage lifecycle that includes product development, technology transfer, manufacturing, and discontinuation. All stages of product lifecycle are controlled through the quality management system, and ensure final product quality is not compromised.

By understanding the 4 stage lifecycle of your product, you will better enable your organization to drive quality into the product from the start, and continuously improve product quality.

It starts with Product Development.

Product Development is the activity of designing the product and processes that lead to product realization. Product development focuses on ensure consistent product quality that meets the needs of patients and consumers, and should take into account all scientific research and process knowledge to make effective decisions.

Begin with the end in mind.

Technology Transfer follows product development, and aims to transfer product and process knowledge into the manufacturing environment and different sites of manufacturing while maintaining consistent product quality through product realization. Technology transfer establishes the foundation for manufacturing processes, manufacturing controls, manufacturing validation, and continuous improvement.

Active Manufacturing.

Manufacturing achieves product realization, or a readily deliverable product to patients or consumers. Manufacturing goals are to maintain a state of control and continuously improve product and processes. This ensures product quality specifications are met for every batch, key performance and process indicators are being maintained, appropriate controls based on risk analysis are used, and that products may be continuously be improved.

The end of the road.

No one likes to admit when it happens them, but not all products are successful with the market – interestingly, it is a category of continuous improvement. An organization will certainly get a better understanding of the market when a product fails to sell. That said, there need to be plans in place to control the products that are still on the market and ensure there is a “firewall” for to protect against claims of products not being safe for use.

Product Discontinuation ensures all records and samples of process and product are retained while discontinued products may still be circulating in the market, in reservation for recall events.

Action you can take:

Continuous Improvement is a buzz word in Quality Management Circles, but is often tough for organizations to deploy consistently. Because of the intricacies of the products, and the big picture nature of continuous improvement activities, we recommend getting all of your Quality Management Systems in place before undertaking the efforts of a Continuous Improvement program.

Quality Management Systems are the key to Continuous Improvement, and the use of those systems will inately get your organization on track for improving product quality. Use the systems, manage your process, and keep track of variation in all resources, and you will be on the right track. Just be sure to keep in mind the stage of product lifecycle, and keep and eye on the process variables.

If you have questions, contact us and we can give you the advice needed to keep on top of your Continuous Improvement.

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Management Review is key to Continuous Improvement.

Management is responsible for maintaining and using the Quality Management System and its periodic review. Such management audits ensure the systems are working as intended and are effective; audits should be used as tools to continuously improve product quality and identify process improvement opportunities, also to include improvement of the Quality Management System.

The Quality Policy and Quality Planning elements of the Quality Management System set the specifications for how product quality is engineered into every stage of manufacturing. Management Review is the follow through to ensure those specifications are being met at every stage of manufacturing. Management Review should happen at a quarterly basis, but is often an annual review. This sets the stage for fulfilling consumer demands, and makes sure consumer perception of the brand remains high.

Actions you can take:

Write the activities of your management team for reviewing Critical Quality Attributes, Variation in past batches, changes in the manufacturing processes, and any customer complaints of products. These are the minimum steps your organization can take to  ensure brand perceptions continuously improve in proportion to the improvement of product quality.

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The Challenge to the Industry

We have a civic responsibility to take action and improve the lives of those that we have the ability to do so. Orion GMP Solutions hopes that by extending this letter that cannabis patients, researchers, and industry stakeholders take the initiative to put their representatives on notice and voice their concerns.
Cannabis used for Phase 2 and 3 clinical research must meet Good Manufacturing Practice Guidelines, such as the 21 CFR parts 210 and 211. Without FDA Approved GMP Cannabis, legitimate researchers are at a loss for understanding the true effects of cannabinoid therapies in treating disease.

Differences in Perspective

We are not here to discredit any institution, but the University of Mississippi is not meeting needs of researchers under the scope that cannabis is a drug of abuse versus a therapeutic medicine. Please take note, that UMiss operates in conjunction with the National Institute of Drug Abusenot with the Office of New Drug DevelopmentThe two institutions have drastically different approaches to drug substances:

NIDA – “To advance science on the causes and consequences of drug use and addiction and to apply that knowledge to improve individual and public health.”

OND – “To ensure that safe and effective drugs and biologics are available to the American people.”

Drug abuse is a real problem that must be addressed, however, complete and rigorous scientific studies of medical cannabis cannot be treated in the same way as studies of common addictive drugs. Current research needs to not only study cannabis as an intoxicant or recreational drug, but also to be able to study its differing medical effects depending on the specific blend/formulation of cannabinoids. Having unreliable or unknown cannabis raw materials for research prohibits the kind of research that needs to happen to fully understand the medicinal properties of cannabis. Only when we can fully quantify and have reliable supplies of the cannabis used for scientific studies can we prove or disprove its health effects.
There are no universally accepted standards for cannabis manufacturing to date, and it makes it incredibly difficult to generate standards without having authority from the government to perform clinical research. Public health cannot be protected, and cannabis manufacturing cannot be standardized without researchers being able to tell the industry what is safe and what is not. We are talking about helping sick people obtain access to what equates to a pharmaceutical substance that is not being manufactured under GMP guidelines.
For now, we must rely heavily on a Risk Based Approach to manufacturing, taking into account how the drug is manufactured relative to the risks posed to a patient.
ASTM D37 Cannabis Standards Committee is drafting guidelines for cannabis manufacturing, but both clinical research and the risk based approach must continue to progress regardless of what standards are being used.

Raw Materials for Clinical Research effect the Quality of the Research

The quality of research or a product is dependent on thousands of variables of the raw materials. Quality of raw materials is particularly important, as it influences the reproducibility of the scientific investigations. If researchers do not have raw materials of consistent quality, their research results will be be taken as inconclusive and cast doubt on an industry surrounded with uncertainty. How can researchers depend on the one government sanctioned supplier, whose quality has been questioned by the DEA, and whose primary aim is to view cannabis from the “drug of abuse” perspective? Here is another perspective – Medical researchers cannot determine the safety and efficacy of a drug if they do not have access to it.
Our team sees these problems while performing GMP Audits in FDA Registered GMP Facilities, whether it’s with product quality or research materials. Groups manufacturing GMP Cannabis will be at a loss for FDA Registration until the clinical research is done to prove the efficacy. Before clinical research can be done, the DEA must get past the hurdle with the Justice Department.

The Opportunity

Mr. Sessions is developing his platform, and we are left with little to do but contact our representatives. This open letter is in support of changing the perspective.
Cannabis is gaining worldwide support from the medical clinicians who can only recommend cannabis. At present, clinicians and pharmacists are unable to prescribe cannabis, as there are no specifications for it as an FDA approved drug. Without clinical research, cannabis will never be able to gain full acceptance by the medical community.

Please Take Action!

Follow these links to contact your representatives:

https://www.house.gov/representatives/find/

https://www.senate.gov/reference/common/faq/How_to_correspond_senators.htm

Copy and paste this letter into your correspondence to your representatives:

I am not only writing to thank you for your support of legislation in regard to cannabis, but also to express my concern for the advancement of cannabinoid therapies. I respectfully request your consideration in being a champion for clinical research that could lead to a better understanding of cannabinoid therapies and treatments that so many can benefit from.

While much progress has been made, the United States is not leading the international community in clinically tested cannabis products. The supply of pharmaceutical grade cannabis is low, as the University of Mississippi is the major supplier of such research materials, and does not fully meet the needs and quality specifications demanded by legitimate researchers, as mentioned in the Federal Register / Vol. 81, No. 156 / Friday, August 12, 2016 / Rules and Regulations.

In August 2016, the DEA opened the opportunity for private companies to manufacture pharmaceutical grade cannabis for legitimate research purposes. This provided a means for researchers to obtain pharmaceutical grade cannabis to prove/disprove the potential of cannabinoid therapies to help people with disease conditions that are not fully treated by currently available pharmaceuticals.

At present, there are running hypotheses that the endocannabinoid system is a physiological regulatory system that interacts with and controls multiple physiological systems. The multiple disease states that cannabis has subjective evidence of helping patients is the best evidence the scientific community presently has. Peer reviewed scientific research is the only way to prove/disprove these hypotheses.

While we have positive subjective evidence for cannabinoid therapies treating disease states, we are unable to make it objective because of the current regulatory environment. Allowing the private industry to manufacture DEA sanctioned Schedule 1 pharmaceutical grade cannabis is a necessary step to treat people with incurable diseases that are not otherwise treated by current pharmaceuticals, and for the United States to remain a leader in innovation.

Unfortunately, the opportunity is being held up by the Justice Department, which pushes back the opportunity for legitimate researchers to help people that are suffering.

I respectfully request your support in making DEA Schedule 1 Pharmaceutical Grade Cannabis available to the medical research community so we may build objective evidence for its applicability in treating disease.

Thank You!
As the CEO and Founder of Orion GMP Solutions, and speaking on behalf of our team of scientists and engineers, we would like to thank you for your support in ensuring that medical research can take place.
 
Respectfully,
-Andrew Samann
CEO and Founder, Orion GMP Solutions
ASTM D37 Cannabis Standards Committee, Quality Management Systems Chairman

Internal Communication has an impact on Product Quality.

Management is responsible for communicating all quality related matters in manufacturing, and ensuring the quality policy is implemented and used with the Quality Management Systems. Communication should be tracked for approval throughout the organizational levels, and ensure all quality related matters are fully completed and closed.

While it seems unnecessary to mention it, Internal Communication requires its own policy. It is the means of ensuring responsibilities and chain of custody of quality issues are communicated throughout the organization, and that no matters are dropped. It is easy for a company to talk about issues, but how those issues delegated to the responsible parties is essential for successful manufacturing.

Action you can take:

Start simple. Write out your organizational hierarchy, and detail who does what. What are the responsibilities? Who communicates with who? How and when should issues be communicated?

This is the fist step your organization can take towards establishing its internal communication policy.

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Resource Management.

Resource management is one of the most important aspects to total control manufacturing. It is the logistics of the organization – it is the right tools, materials, labor, and manufacturing conditions in the right place, at the right time. In smaller operations, managing these elements is often neglected, and is a root cause for inability to scale or perform tech transfer.

Materials used in manufacturing are allocated according to resources, processes, and product needs relative to raw materials, equipment, facilities, labor, and management, and are managed by the Quality department through the Quality Management System.

Action you can take:

Resource management starts with characterizing the logistics of your organization. We take a product based approach, listing out all resources need to take raw materials, etc, and turn them into a finished product. We are talking about total control, so this extends down to the lowliest of tasks such as daily sanitation activities and the resources needed to keep a sterile manufacturing environment. This sets your organization up with the minimum requirements for resource management that you can then build into your Quality Management Systems.

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Quality Policy.

A manufacturer’s Quality Policy describes the desired results for meeting quality specifications of products. The quality policy includes specifications on how the manufacturer meets regulatory requirements and how the QMS can be improved to meet organizational needs of continuous improvement. The quality policy applies to all employees involved in manufacturing.

Quality Planning.

Quality related matters are the direct responsibility of management and leadership. Quality planning is related to the quality policy, and internal auditing of meeting the specifications of that policy. All quality related matters must be supported to all personnel, and align with the quality policy. Key performance indicators of quality matters must be fully communicated and related to the quality policy.

Action you can take:

Start writing your organization’s quality policy by with making a list of the Critical Quality Attributes for each product being manufactured. Then write out what processes are related to each product, and what process specifications must be controlled in order to meet the product Critical Quality Attributes. These are the key steps to flesh out your quality policy.

You can not measure what you do not manage. Once you have a Quality Policy in place, you have set a baseline for managing your product quality. Develop a robust testing plan to measure your variation in meeting specifications. Develop in-process testing to ensure you are meeting process specifications before final release testing, and get the piece of mind that products are on track for meeting specifications before you send them to a 3rd party lab.

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Management Responsibilities.

Leadership and Management in a manufacturing environment is responsible for all success or failures of the organization. Yes, that is correct. When there are failures, it is a result of management not taking serious interest in the success of the company. If there is success, it is a result of leaders taking the right actions to organize and supervise all manufacturing operations.

The commitment of executive leadership in product quality is essential to meet critical quality attributes.  It is the responsibility of management to establish risk-based approaches to product quality and ensure specifications are met in all aspects of manufacturing. In our experience with auditing, the best companies have their executive leadership in the conference room, taking note of all opportunities for improvement.

Management Commitment.

Management is the responsible party for implementation and use of Quality Management Systems and Good Manufacturing Practices, and use these systems to ensure targeted Quality Objectives are met. Management starts with defining all roles and jobs within the organization, delegating appropriate authority, an communicating the desired results for the organization.

This is not an easy job, and it again, starts with understanding the Critical Quality Attributes of the products, and ensuring all process specifications are consistently met. When Critical Quality Attributes are not met, management through Corrective Action and Preventative Action ensures that the next batch will meet those specifications.

Action you can take:

There is a saying in the Marine Corps: “Leaders eat last.” Leaders will, however, have to take the majority of this task on themselves. Establishing the relationship of leaders relative to the manufacturing processes is a intricate process of applying the fields of Industrial Organizational Psychology, Organizational Development, and Change Management.

Giving us a call to help you strategize on your leadership responsibilities and we will give you the action plan.

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Documentation is key.

Documentation must be designed and structured in order to be useful to everyone involved in the manufacturing process. Documentation of Quality Management Systems must be available and understood by all personnel that have an influence over product quality. This requires a top-down approach to how a manufacturer organizes their knowledge of the process, starting with big picture processes, and further defining how the Quality Management System applies to total control manufacturing.

How and Where to apply Quality Management Systems.

When implementing a Quality Management System, a manufacturer should consider how and where to apply the systems so they do not over-engineer solutions where problems will not exist. This, again, ties back to Quality Risk Management and understanding the results and quality specifications required for each stage of manufacturing.

Quality Risk Management should be considered from the beginning of Quality Management System development. Implementation of Quality Management Systems cost companies money, and should be selectively used where risks exist, rather than a company wide implementation. While all companies could benefit from full applications of QMS, there are many activities that would have no benefit from such systems.

Quality Assurance and Quality Control.

QMS is not a self operating stand alone system – it requires Quality Assurance and Quality Control Departments. These departments, which are separate from production, are the managers of quality. It requires investment into identifying the appropriate processes and resources that must be controlled to meet Critical Quality Attributes.

Essential Elements of the Quality Management System.

At a minimum, QMS should include process performance and product quality monitoring, CAPA, change management, and management review. These systems are the essential elements to ensure that products meets Critical Quality Attributes, and that product quality is continuously improved.

Action you can take:

It’s no small challenge to build a Quality Management System. While we normally have direction actions, we feel it is highly valuable to have a 5-10 hour block with one of our consultants in order to set up the systems. If you prefer, you can directly hire a seasoned Quality Assurance manager, and they will be able to set your Quality Management System up from the start.

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