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.

More articles like this one:

ASTM D37: Cannabis Standardization through Collaboration

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 […]

0 comments

Vendor Agreements

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. […]

0 comments

Continuous Improvement

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 […]

0 comments

Management Review

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 […]

0 comments

DEA/FDA Schedule 1 Cannabis Manufacturing – GMP Cannabis

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 […]

0 comments

Internal Communication

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 […]

0 comments

Resource Management

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, […]

0 comments

Quality Policy and Planning

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 […]

0 comments

Management Responsibilities and Commitment

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 […]

0 comments

Quality Manual

What is a Quality Manual? The Quality Manual documents all aspects of the organization’s policies and procedures of the Quality Management System. It is the 1000 Meter view (yes, we […]

0 comments

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.

More articles like this one:

ASTM D37: Cannabis Standardization through Collaboration

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 […]

0 comments

Vendor Agreements

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. […]

0 comments

Continuous Improvement

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 […]

0 comments

Management Review

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 […]

0 comments

DEA/FDA Schedule 1 Cannabis Manufacturing – GMP Cannabis

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 […]

0 comments

Internal Communication

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 […]

0 comments

Resource Management

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, […]

0 comments

Quality Policy and Planning

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 […]

0 comments

Management Responsibilities and Commitment

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 […]

0 comments

Quality Manual

What is a Quality Manual? The Quality Manual documents all aspects of the organization’s policies and procedures of the Quality Management System. It is the 1000 Meter view (yes, we […]

0 comments

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.

More articles like this one:

ASTM D37: Cannabis Standardization through Collaboration

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 […]

0 comments

Vendor Agreements

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. […]

0 comments

Continuous Improvement

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 […]

0 comments

Management Review

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 […]

0 comments

DEA/FDA Schedule 1 Cannabis Manufacturing – GMP Cannabis

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 […]

0 comments

Internal Communication

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 […]

0 comments

Resource Management

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, […]

0 comments

Quality Policy and Planning

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 […]

0 comments

Management Responsibilities and Commitment

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 […]

0 comments

Quality Manual

What is a Quality Manual? The Quality Manual documents all aspects of the organization’s policies and procedures of the Quality Management System. It is the 1000 Meter view (yes, we […]

0 comments

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