Improving Product Safety And Distribution

Improving Product Safety And Distribution Tyler Williams, CSQ. Tyler is the founder and Chief Technical Officer of Cannabis Safety & Quality (CSQ). Over the years, Tyler has diligently worked with various industry stakeholders and conducted sample audits on several cannabis cultivators and manufacturers to create the first global cannabis safety & quality Certification Scheme. Tyler currently sits on the Policy Council and the Cannabis Manufacturing Committee for the NCIA, in addition to serving as a member of the National Industrial Hemp Council (NIHC) and the Safe Quality Food Institute’s (SQFI) Cannabis Working Group. In 2019, Tyler started a non-profit organization called Show Me Food Safety. This organization provides resources to small food manufacturers and growers with help in improving their food safety practices, getting on the shelves of local grocery stores, and improve the overall health of consumers. Even with a detailed roadmap and double and triple-checking everything, we live in a world of uncertainty and chaos, so something is bound to fall through the cracks or go wrong, no matter how carefully you prepare. Tyler stated that there are some things that cannot be prevented by following basic cGMPs. We dive into a little more on where cGMPs may miss the mark and more. Tyler recently contributed a blog to NCIA’s website about getting a third-party audit. So essentially asking experts OUTSIDE of his company, not within, to look around, “check under the hood, check the fluid levels,” etc. We have Tyler tell us some of the benefits of getting a third-party audit, as well as why a cannabis company should do this.

Listen to “Improving Product Safety And Distribution” on Spreaker.

Originally Posted: NCIA’s Cannabis Industry Voice

How Third-Party Safety And Quality Audits Can Help The Cannabis Industry Self-Regulate And Avoid Mandatory Regulations

July 28, 2020

by admin Cannabis Audit News NCIA News

How Third-Party Safety And Quality Audits Can Help The Cannabis Industry Self-Regulate And Avoid Mandatory Regulations

by Tyler Williams, founder and Chief Technical Officer of Cannabis Safety & Quality (CSQ)

The disadvantages of receiving a third-party audit are apparent – it takes a lot of time to build a cannabis safety and quality program that meets audit requirements, and the costs of an audit can be relatively expensive. Additionally, if your company decides to use an external consultant to help develop your cannabis safety and quality program, it can add even more costs to the equation. So why bother getting a third-party audit at all if it is not mandatory? If the ethical response of “it’s the right thing to do” does not resonate, consider these more practical responses.

Legal Protection
Note that the lack of legal requirements for cannabis cultivators and manufacturers does not offer protection from legal action, and defending against litigation can be expensive even if a company prevails.
Brand Protection
If a consumer becomes ill (or worse) from ingesting or inhaling one of your company’s products, the negative public backlash and decline in consumer confidence can damage both your company’s bottom line and the industry as a whole.
Insurance Benefits
Insurance companies evaluate cannabis businesses based on their history and their current safety programs they have in place (e.g. GMPs, Recall Programs, Supplier Approval Programs, etc.). Whether or not a company has programs like these in place can influence the costs of their insurance. Additionally, third-party audits give cannabis businesses a verification record that their safety and quality programs are operating as intended. This verification record could help that company when dealing with insurance claims made from recalls or other adverse events.
Marketing Benefits
Enhance your company’s marketability by becoming certified to a third-party audit standard. For example, the new CSQ Standard lists all their certified locations on their website. This database creates a network of cannabis businesses who all meet industry requirements. Cannabis retailers will be able to search this public database and determine to do business with a cultivator or manufacturer based on their compliance with the CSQ Standards.
Self-Regulation
By proactively self-regulating, the cannabis industry can mitigate the possibility for high-profile recalls or outbreaks that might prompt regulators, such as the FDA, to establish mandatory and imposing regulations for the industry. Mandatory regulations could have a more burdensome effect and even be more costly than self-regulation with third-party audits.

Self-regulation is always preferable to mandatory regulation, and evidence of this is found in the alcohol industry’s self-regulation of marketing and advertising, as well as the video gaming industry’s self-regulation of video game ratings by the Entertainment Software Rating Board (ESRB). While third-party audits are not mandatory in every region, a voluntary and proactive approach that includes third-party auditing of cannabis cultivators and manufacturers will keep consumers safe and protect your company’s bottom line. All while avoiding adverse incidents that would initiate further scrutiny of the cannabis industry or prompt mandatory regulations.

To ensure that the industry is self-regulating properly, there are five proposed principles for self-regulation through third-party auditing.

A set of transparent and specific standards created by industry stakeholders that includes a public comment period.
External oversight through accreditation bodies, benchmarking organizations, and other external committees to ensure no disproportionate power or voting authority.
A public database in which individuals can search what companies are compliant with the requirements.
Transparent procedures for stakeholders to file complaints and provide feedback on the standards and their enforcement.
Periodic assessments and reviews to determine if the goals of the standards are being met.

In addition to setting sound principles for industry self-regulation, it is also important to highlight things that could potentially go wrong with self-regulation. The following three practices are often associated with the failure of a self-regulating system.

Weak standards that do not apply globally and permit unsafe practices.
The absence of transparency or weak oversight can undermine the objectives of the self-regulating system.
Industry leaders neglect to be part of the movement towards self-regulation.

For this reason, I urge industry leaders to sign a commitment to provide the safest and highest quality products possible and volunteer to be part of the movement of self-regulation of the cannabis industry through independent third-party audits.

ABOUT THE AUTHOR

Tyler Williams is the founder and Chief Technical Officer of Cannabis Safety & Quality (CSQ). Over the years, Tyler has diligently worked with various industry stakeholders and conducted sample audits on several cannabis cultivators and manufacturers to ensure the CSQ audit requirements meet the needs of this new and booming industry. Tyler currently sits on the Policy Council and the Cannabis Manufacturing Committee for the NCIA.

Before founding CSQ, Tyler was the Vice President of Operations for ASI, one of the leading food safety auditing, training, and consulting companies in the U.S. In this position Tyler was responsible for the certification process of over 3000+ audits annually and managed ASI’s employees and contracted auditors around the world. In addition to managing the day-to-day operations of ASI, Tyler also trained and consulted several different major food and beverage companies around the world to help improve their food safety practices.

In 2019, Tyler started a non-profit organization called Show Me Food Safety. This organization provides resources to small food manufacturers and growers in Missouri to help improve their food safety practices and get on the shelves of local grocery stores.

Originally Post: thecannabisindustry.org

Committee Blog: Facts About Current Good Manufacturing Practices (CGMPs) And Their Role In The Cannabis Industry

April 28, 2020

by admin NCIA News

Committee Blog: Facts About Current Good Manufacturing Practices (CGMPs) And Their Role In The Cannabis Industry

By Ellice Ogel, Tyler Williams, Peter Dougherty, David Vaillencourt, Trevor Morones
NCIA’s Cannabis Manufacturing Committee

A Primer on current Good Manufacturing Practices

What are GMPs?

Good Manufacturing Practices (GMP) are minimum requirements to ensure that products are created in a manner that ensures they are of consistent quality and safe for their intended use. If a product is found to be produced in a facility that does not meet GMPs, they can be considered adulterated and unsafe. In the U.S., the U.S. Food & Drug Administration (FDA) regulates the manufacture and sale of food and beverages, dietary supplements, pharmaceutical products, and cosmetics by requiring adherence to GMPs. The “c” in cGMP stands for current, meaning that how companies conform to GMPs must continually evolve with the development of new scientific research and industry best practices. Today, the two terms are used interchangeably. While cannabis is not recognized as a legal product at the federal level, federal legalization will inevitably result in the requirement for cannabis producers to conform to cGMPs.

cGMPs can be broken into six major sections (1) Management Commitment, (2) Risk Management, (3) Quality Management Systems, (4) Site & Facility Management, (5) Product Controls, and (6) Staff Training (Figure 1).

Why are cGMPs important?

cGMPs are important for every industry to ensure manufacturers are producing safe products. A site that isn’t following the minimum requirements for cGMPs in their specific industry is putting the basic well-being of consumers around the world at risk, which the FDA terms adulterated. cGMPs provide assurance that steps within the manufacturing process result in passing final product testing. Final product testing alone is not enough to ensure the safety of consumers. In most cases, final product testing is completed on a small sample batch, so that manufacturers are not wasting the final product on sampling and testing. For example, if the manufacturer is producing 1 million dietary supplements, the manufacturer might only test 100 tablets from that batch. This means that if cGMPs are not being followed and there is no consistency in the safety of producing that product, then some of the products may be safe for consumption, while others may not. This results in product recalls or withdrawals, damage to brand reputation, and lawsuits. A recent study by the Denver Department of Health found that 80% of cannabis products on dispensary shelves failed testing despite passing final batch testing prior to sale.

What do cGMPs include?

Every industry regulated by the FDA has its own guidelines for cGMPs, which are found within Title 21 of the Code of Federal Regulations. Unique differences between cGMP requirements for each industry exist. If your company has multiple product lines that fall into any of these different industries, understanding how these differences will impact you are critical. Figure 2 provides a high-level overview of the major GMP topics that are required by industry.

Industry Type	Location of primary GMPs within 21 CFR
Food & Edibles	21 CFR 117
Dietary Supplements	21 CFR 111
Pharmaceutical	21 CFR 211
Cosmetics	See Draft Guidance for Cosmetic Good Manufacturing Practices

Figure 3 Table of the major industry types regulated by the FDA and where one can find the major cGMP requirements

Not all GMP topics are referenced in the primary section of the CFRs, which can make it difficult for people who are new to GMPs to ensure they are appropriately prepared. For example, the food and beverage cGMPs (21 CFR 117) does not include packaging and labeling controls, whereas the pharmaceutical cGMPs (21 CFR 211) does include packaging and labeling controls. 21 CFR 101 is home to packaging and labeling statues for the food and beverage industry.

Each sector regulated by the FDA has overlap which contributes to talent acquisition/recruitment from other industries.

THIRD-PARTY cGMP AUDITS

What are Third-Party cGMP Audits?

A third-party cGMP audit is a systematic independent and documented activity in which objective evidence is gathered and assessed to determine if the site’s cGMP system is appropriate and effective. In the 1990’s third-party GMP audits were like an inspection you would receive from the FDA or local health department. This means there was a heavy focus on the building itself and what was happening on the production line during the time of the audit. Nowadays, cGMP audits typically include much more than what is required from the Code of Federal Regulations (CFR). Examples of this include extra requirements for Hazard Analysis Critical Control Points (HACCP) and a much heavier review of documentation to ensure best practices are being followed all the time and not just on the audit day.

Benefits of Using an Experienced and Accredited Certification Body

One thing to keep in mind when considering a third-party cGMP audit is whether or not the audit is accredited. Certification Bodies are accredited (approved) by an Accreditation Body, to ensure their internal procedures and audit processes follow strict guidelines for different audit standards. If approved, the CB gets accredited to that specific audit standard. This along with direct oversight of the audit Scheme Owner and the Accreditation Body ensure that the Certification Body has qualified auditors and that the entire audit process goes through several quality checks before it becomes “final.” In the U.S., the three major accreditation bodies approved to do this are:

For more information on this process, one should refer to the International Accreditation Forum (www.iaf.nu).

WHY SHOULD MY COMPANY RECEIVE A 3rd PARTY cGMP AUDIT?

Unlike the food & beverage, dietary supplement, pharmaceutical, and cosmetics industries, cannabis is federally illegal in the United States. This means there are no federal regulations for cGMPs in the cannabis industry. However, some states, such as Florida, have taken the initiative and implemented requirements to have all cannabis facilities become audited to a cGMP standard before they can receive their license to begin manufacturing.

As the cannabis industry continues to evolve, retailers and others downstream in the supply chain will demand that cannabis manufacturers provide evidence of a certain level of quality and safety in their products. An attestation or certificate from a third-party demonstrating that your facility meets cGMP requirements is an internationally recognized way to provide that evidence and establish trust. Globally, third-party cGMP audits are crucial to maintaining product safety and quality by providing a third set of eyes to verify what is working and what is not. Besides regulatory requirements and customers requiring your facility to get a third-party cGMP audit, there are numerous other benefits to receiving a cGMP audit. Some of these benefits include the following:

Reduction in failed product testing
Improvement of product safety
Improvement of product quality and consistency
Eliminating potential risks and possible recalls
Marketing advantages over competitors who are not audited by a third-party
Improvement to consumer confidence and an increase in brand loyalty

ROADMAP TO cGMP CERTIFICATION

Management Commitment

It is essential to the entire cGMP system to have commitment from top-down. Without this, your site will not receive the resources (e.g. people, equipment, tools, budgets) it needs to implement an effective cGMP system. The culture of an organization requires everyone to practice what is lectured. Simply; Say what you do, do what you say.

Start Preparing Early

Be realistically courteous to the timeline by generating an internal analysis. Using the scheme, the audit will be against, create a list of programs you currently have, and which are missing. Working towards a better score early will provide greater long-term value.

The very first thing you need to do before you start making major changes to your facility or procedures is to identify which GMP standard or standards you intend to meet. With this established, you can select a Certification Body and obtain a copy of the audit form or checklist that they will use to assess you.

Assess Your Current Level of Conformance

Establish an audit team and conduct a thorough assessment of your current organization. If this is new to your organization and staff, it is beneficial to work with a GMP expert that has experience in both cannabis and the cGMP program you are going to be audited against. Review your entire system against the audit checklist and highlight or markup items your site is already doing. This allows you to focus on the things you are missing and close any “gaps”.

Implementation and Teamwork

The preparation of an audit should never rest on the shoulders of one person. Your site should establish a multidisciplinary/interdepartmental team to implement the various tasks based on the findings from your initial assessment. Collaboration is key to successfully preparing for a cGMP audit, especially when timelines set by upper management are very stringent.

Training

Training is essential in preparing for your cGMP audit and business in general. This helps close the gaps between what your safety and quality department has developed and what your front-line employees are applying. All employees should understand what cGMPs are and how it applies to and benefits their daily activities.

Establish Your Internal Audit Program

Conducting internal audits is an effective way to not only prepare for your cGMP audit but to continually improve your organization. Breaking down your entire audit checklist into department or process-specific sections, you can establish the frequency of auditing these bite-sized sections. Should they be reviewed annually, semiannually, quarterly, monthly, or continuously throughout day-to-day operations? Some things, like reviewing your suppliers, may only need to be done annually, while things such as pre-operational inspections should be performed daily. Always use the actual audit checklist to observe your documents and facility to see if there are any gaps. Whenever possible, the person or team conducting the internal audit should never review their own work. Establishing any issues or non-conformances should be noted, evaluated, corrected, and closed out.

Schedule Your Third-Party Audit

A third-party mock audit is the closest thing you can get to an actual audit. This is where a third-party company would come in and evaluate your site to the specific cGMP standards and give a formal report over any deficiencies found during the assessment. This is a great way to test your preparedness before the actual audit.

Address Non-Conformances and Celebrate!

Your auditor will almost certainly identify areas where you are not fully compliant, known as non-conformances. Depending on your level of preparedness, you will hopefully have only a few Minors, but non-conformances can be classified as Major or Critical. You will work with your auditor to establish actions and a timeline to effectively resolve these non-conformances and provide follow up evidence of their closure. After successfully closing out your non-conformances, you will be rewarded with a certificate or attestation. Sit back, relax, celebrate! With a cGMP system in place, the established intervals to audit your system will ensure you have the tools and knowledge to maintain your cGMP status!

Originally posted on thecannabisindustry.org

THE KEY TO CONSUMER SAFETY: DISPLACING THE ILLICIT CANNABIS MARKET RECOMMENDATIONS FOR SAFE VAPING

February 4, 2020

by admin NCIA News

THE KEY TO CONSUMER SAFETY: DISPLACING THE ILLICIT CANNABIS MARKET RECOMMENDATIONS FOR SAFE VAPING

“...We Attempt To Clear Up Some Of The Myths That Exist About Vaping Cannabis Oil And Offer Explanations For Other Potential Dangers And Strategies For Minimizing Risk.”

INTRODUCTION AND NCIA’S SAFE VAPING TASK FORCE

As reports began to appear of a potential linkage between
lung injuries and use of nicotine and/or cannabis vaping
products, NCIA’s Policy Council established a Safe Vaping
Task Force to provide a consistent response on behalf of the
concerned members of the regulated cannabis industry. The
Task Force’s mission was to communicate clearly in response
to press reports and governmental actions, and articulate
the state-legal cannabis industry’s fulsome efforts to act with
integrity as responsible actors. The Task Force produced and
published weekly blogs summarizing recent developments
and the cannabis industry’s response; drafted Congressional
testimony for a Senate Health, Education, Labor and Pensions
(HELP) Committee hearing on November 13, 2019; drafted
op-eds; collaborated with other safe vaping efforts, including
in California; and started the planning for a summit in Boston
on February 19, 2020 to facilitate collaboration between law
enforcement and the private sector to tackle the illicit market
through public-private partnerships.
The Task Force’s efforts transitioned to a new phase in late
November when health experts confirmed that the proximate
cause of many of the injuries and deaths were attributable
to vitamin E acetate used as a thinning agent in illicit market
products. With a diminished need to provide rapid response to
the misleading data points appearing in reports of this crisis, our
work began to focus squarely on a long-term solution. Below
are recommendations from the Task Force regarding safe
vaping. By offering this industry subject matter expertise, it is
our hope that consumers, retailers and government agencies
will become better informed as a result of our collective efforts.
Today, it appears that public health experts have concluded that
additives from the illicit market appear to be the primary cause

of this crisis.1 While that work continues, we attempt to clear
up some of the myths that exist about vaping cannabis oil and
offer explanations for other potential dangers and strategies for
minimizing risk.
Ultimately, one thing is clear: we must stop the flow of
unregulated and untested products to consumers from the
illicit market. That is the best solution to the vaping crisis,
which is not likely to dissipate unless we take swift action to
put illegal and unscrupulous operators out of business. That
effort will take a collaborative approach, with law enforcement,
state-legal cannabis businesses, state cannabis taxing and
licensing agencies, providers of anti-counterfeiting technology
and others working in concert. Information sharing between
the public and private sectors here will be key. And while we
must disrupt the illicit market, we need to identify alternatives
to arrest and prosecution and we must create reasonable
paths to state licensure. It will take forward-looking elected
and appointed leaders to make sure that we displace the illicit
market, while remembering that the industry made 12 billion
dollars in 2018 while approximately 600,000 people were
arrested for marijuana-related arrests.2 Fundamental fairness
must play a role in any solution to the illicit market problem. We
need to evaluate and refine state regulations by encouraging
smart regulation at the state level, such as the banning of certain
additives as seen in Colorado. States must continue evaluating
what is necessary to keep consumers safe and implement
appropriate regulations. In the end, sensible regulation and
a clear path to licensure and compliance will be the utmost
compelling force in driving people from the illicit market to the
state-legal market.

TABLE OF CONTENTS

INTRODUCTION AND
NCIA’S SAFE VAPING TASK FORCE

ACKNOWLEDGEMENTS

DISPLACING THE ILLICIT MARKET

COUNTERFEIT CARTRIDGES
VAPORIZER LIQUID FORMULATIONS

VAPORIZER DELIVERY DEVICES

POSSIBLE CONTAMINANTS AND TESTING

RECALLS IN A REGULATED MARKET
MARKETING TO CHILDREN AND TEENAGERS

STATE GOVERNMENT ACTIONS
CONCLUSION

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