Muddied Waters

BOULDER WEEKLY

DEA releases proposed rules for hemp and CBD, reigniting fear and confusion within the industry.

By: Will Brendza

Hemp farmers everywhere sighed with relief when the Farm Bill was renewed in 2018. That renewal effectively decontrolled hemp, removing the plant from the definition of “marijuana” in the Controlled Substances Act and shifting the responsibility of enforcement from the Drug Enforcement Agency (DEA) to the U.S. Department of Agriculture (USDA).

That’s a very important distinction, according to Henry Baskerville with Fortis Law Partners. The USDA is very pro-farmer; they want to work with farmers to help them succeed and produce as much as they can, he says.

“The DEA, of course, is the opposite. They’re wanting to stamp out any sort of drug issues,” Baskerville says. “If you run afoul of the [USDA], they’re not raiding your farm with automatic rifles.”

The relief the 2018 Farm Bill offered was short-lived, however. In August of this year, the DEA released a slate of proposed rules for the hemp and CBD industry, which has once again stirred up nervousness and confusion among farmers and producers who don’t want to end up on the wrong side of the law.

“Any time the DEA is trying to shoulder their way back into the party, for hemp farmers that’s a scary prospect,” says Baskerville, who works almost exclusively with cannabis, hemp and CBD clients.

This Interim Final Rule (IFR), effective Aug. 21, aims to implement some of the Farm Bill’s hemp amendments into the Federal Controlled Substances Act (CSA).

Some background: According to the 2018 Farm Bill, the difference between “hemp” and “marijuana” comes down to delta-9 THC content and that’s it. Legally speaking, hemp that exceeds .3% delta-9 THC becomes marijuana. Scientifically, though, both are part of the same family: cannabaceae; and even of the same genus: cannabis — no matter what their THC levels are.

Meaning that hemp farmers have to walk a very fine line. They’re growing the exact same plant as pot farmers, but if their product exceeds that .3% delta-9 THC threshold, then they are suddenly running an illegal operation.

Should that happen, under the 2018 Farm Bill, farmers or producers would have been dealing with the USDA. However, the DEA’s new IFR suggests that, in fact, hemp farmers aren’t yet out of the woods. If their flower or extract accidentally spikes over .3% delta-9 THC — at any point during the growing or extraction process — the responsibility of enforcement shifts back over to the DEA, and the farmer could be facing a massive fiscal loss as well as criminal charges.

Which is a daunting prospect considering how much THC content can fluctuate with small environmental changes: simple sugars in the soil, temperature changes in a grow room and humidity can all cause THC levels in hemp plants to spike. And during CBD extraction, another cannabinoid known as THCA can be easily and accidently converted into delta-9 THC, Baskerville explains.

“During the heating process, you can inadvertently convert THCA (which is a non-illegal substance) into delta-9 THC, thereby making a product that was previously under the threshold suddenly go above,” Baskerville says.

Baskerville’s problem with that is simple: A hemp farmer trying to responsibly run a business, working hard to comply with the law, can still unintentionally and quite suddenly become a criminal and subject to the DEA’s wrath.

“If you’re trying to run a legitimate business, and trying to do the right thing, and you nevertheless get ensnarled with the government or get accused of engaging in illegal conduct, that is a problem,” Baskerville says. “When people are unwittingly ensnarled with the law, then we’ve got an issue.”

So, what can hemp farmers and CBD producers do to protect themselves in light of the DEA’s new IFR?

Tyler Williams is the founder of Cannabis Safety and Quality (CSQ), a St. Louis-based cannabis certification company that works with a lot of hemp farmers and CBD businesses to minimize risks and protect their brands. He says that seed-to-sale quality certifications are the industry’s best friend right now.

“The best thing you can do, as a hemp farmer or CBD manufacturer, is to have all your ducks in a row,” Williams says. “This is an industry where you walk a fine line of what’s legal and what’s not. And if you have all the paperwork showing that you’re trying to do the right thing, that’s going to go a long way. No matter what happens from this IFR.”

Williams says, producers and farmers should get certified for safety and quality. Not just to ensure quality to their customers, but also to create a paper trail proving that they have been trying to play by the rules.

Williams also notes that the IFR released by the DEA is still in its public comment period until Oct. 20, meaning nothing is set in stone yet.

“What I’ve been telling my clients is, let’s see what comes out of these public comment hearings,” Williams says, explaining that industry groups like the National Cannabis Industry Association (NCIA) have already put together formal comments for the DEA about these proposed rules.

Which will hopefully help clarify whatever the DEA is trying to convey through this IFR.

“The DEA probably thought that they were providing guidance and clarification on the ruling,” Williams says. “Instead, they just confused a lot of people and muddied the waters.”

Originally Posted: Boulder Weekly

DEA Hemp Rule Raises Questions About Compliance

LAW WEEK COLORADO

Uncertainty and questions about testing and enforcement abound

By: Avery Martinez

The release of a new interim final rule on hemp from the Drug Enforcement Administration in August has caused some concern within the hemp industry. Public comment is currently being taken on the rule until Oct. 20, however, the interim rule has highlighted issues within the hemp industry in testing for THC and concerns over remaining compliant.

The Agricultural Improvement Act of 2018, also known as the Farm Bill, allows production of hemp, and the Controlled Substances Act no longer controls hemp, according to the U.S. Department of Agriculture website. The bill also directed the USDA to issue regulations and guidance to implement a regulatory framework around hemp production across the nation.

The DEA’s interim rule seeks to codify the amendments to the Controlled Substances Act made by the Farm Bill into their regulations. The DEA website states that the interim final rule regards the scope of regulatory control over “marihuana, tetrahydrocannabinols [THC] and other marihuana-related constituents” and doesn’t add additional requirements to the regulations.

Under the Farm Bill, the definition of “marihuana” means all parts of the plant “Cannabis sativa L.” growing or not, the seeds, resin extracted from the plant and every compound, manufacture salt, derivative, mixture or preparation of such plant seeds or resin, according to the DEA website.

Hemp, however, is defined as any part of the same plant, including seeds and derivatives, extracts, cannabinoids, isomers, acids, salts and salts of isomer whether growing or not “with a delta-9-tetrahydrocannabinoil concentration of not more than 0.3 percent on a dry weight basis,” according to the DEA site.

The website goes on to state that with these definitions, any such material that contains greater than the .3% of THC “on a dry weight basis remains controlled in schedule I.

However, keeping hemp below that .3% can be difficult, and has several members of the hemp community concerned that they may inadvertently break the law.

This complete article appeared in the Oct. 5 issue of Law Week Colorado. Check out the print issue for the entire article with insights from CSQ’s fearless leader, Tyler Williams

Originally Posted: Law Week Colorado

How To Read A Certificate Of Authenticity (COA)

What is a Certificate of Authenticity (COA), and why should you read it – or even care? You’ve likely encountered this acronym since starting your shopping search of CBD products to help enhance your life. Most brands make this document available for viewing or download to prove pedigree, as it were.

“A Certificate of Authenticity or COA is a document from an accredited lab showing the cannabis profile (of the hemp oil), such as how much CBD and THC,” says Tyler Williams, founder, and chief technical officer for Cannabis Safety & Quality (CSQ). His company provides a set of industry standards and best practices from seed-to-sale for organizations across the cannabis industry. He also sits on the Policy Council and the Cannabis Manufacturing Committee for the National Cannabis Industry Association (NCIA). For good measure, he serves on the National Industrial Hemp Council (NIHC) and the Safe Quality Food Institute’s (SQFI) Cannabis Working Group, as well. Let’s just say he knows cannabis safety as well as anyone.

Improving Product Safety And Distribution Podcast

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

Bill To Regulate CBD As A Dietary Supplement Introduced In Congress

The bipartisan measure is called The Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2020.

A bill that would allow CBD derived from hemp to be sold as a dietary supplement was introduced in the House of Representatives last week in a bid to jumpstart an industry hampered by inaction from the U.S. Food and Drug Administration (FDA).

The bipartisan measure, The Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2020 (H.R. 8179), was introduced on Friday by Democratic Rep. Kurt Schrader of Oregon and Rep. Morgan Griffith, a Republican from Virginia.

“Hemp was historically an important crop for Virginia farmers, and dietary supplements made from it do not possess dangerous addictive qualities,” Griffith said in a statement. “Nevertheless, the current state of regulation creates confusion about its legal uses. I joined this bipartisan bill to provide certainty for hemp farmers that their crop may find legal uses.”

Measure Builds On 2018 Farm Bill

If passed, H.R. 8179 would ensure that cannabidiol (CBD) and other non-intoxicating constituents of hemp could be lawfully marketed as a dietary supplement under the Federal Food, Drug, and Cosmetic Act. The bill would also require CBD and other hemp extract products to be manufactured and sold under existing regulations for dietary supplements. Hemp and products derived from the crop, including CBD, were legalized under the 2018 Farm Bill. But while the FDA has asserted the authority to regulate CBD under the bill and stated that selling ingestible CBD products is illegal, the agency has so far failed to issue guidance for CBD to be used as a dietary supplement or as an ingredient of foods and drinks.

Brandon Beatty, the CEO of Bluebird Botanicals and the director of the industry group the U.S. Hemp Roundtable, explained the importance of the legislation in an email to High Times.

“This bill is critical to regulating and opening up the CBD dietary supplement market. Since the passage of the 2018 Farm Bill, hemp and CBD have been legal yet not fully approved for use in dietary supplements by the FDA,” Beatty said. “The FDA has been investigating a regulatory path forward for the nascent industry, yet this process has been extremely slow – and in that time, shady “fly-by-night” CBD companies have been able to proliferate and market unsafe or improperly labeled CBD products to the detriment of consumers and other CBD companies. The industry simply cannot wait any longer for regulation, and this bill allows Congress to step in and mandate the FDA to finish its work in a more timely manner.”

Beatty added that the legislation would benefit both his business and the CBD industry as a whole.

“This bill will greatly support Bluebird Botanicals’ business by outlining clear guidance for the manufacturing, marketing, and commerce of our CBD products,” he said. “It’ll also help weed out some of our untrustworthy competitors by requiring CBD companies to comply with new dietary ingredient requirements and other existing policies such as adhering to Good Manufacturing Practices.”

Lack Of Action Stifling The Industry

Shawn Hauser, the chair of the hemp and cannabinoids practice at the law firm Vicente Sederberg LLP, said in a virtual interview that inaction from federal regulators is stifling the fledgling hemp industry in the United States.

“The FDA has failed to act to regulate hemp and hemp-derived CBD products in the nearly two years since hemp farming was legalized, resulting in regulatory uncertainty and inadequate oversight of products in the consumer market,” Hauser said. “The FDA’s inaction is hampering the promising U.S. hemp economy and devastating farmers and businesses across the supply chain.”

Tyler Williams, the founder of the Cannabis Safety & Quality product certification program, characterized H.R. 8179 as “a step in the right direction,” but added that more guidance is still needed from Congress and the FDA.

“I think this is a great starting point, but this is only a band-aid on a much bigger problem. For instance, this means that CBD would still be illegal to put into food and beverage products,” Williams said in an email. “Why are we saying it is safe for people to consume as a dietary supplement, but not as a food and beverage product? The bill also doesn’t address the cultivation of the product or what regulating body it will fall under (i.e. USDA or FDA).”

After its introduction on Friday, The Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2020 was referred to the House Committee on Energy and Commerce for its consideration.

Originally Posted: High Times

MJBulls Media: Cannabis Podcast

CANNABIS AND CORONA:

Cannabis and Corona is an optimistic show about cannabis companies that are thriving during the Covid-19 Crisis.

Thursday September 3, 2020:

MJBulls welcomes Founder and CTO, Tyler Williams, of CSQ Cannabis Safety & Quality. Tyler will share insights about CSQ, 3rd party cannabis audits, recalls, and how the industry is being affected by COVID-19.

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

ASI Global Launches Cannabis Safety & Quality Audit Standards

The company announced this week the launch of its new Cannabis Safety & Quality Scheme (CSQ) for auditing standards, with a public comment period open until July 31.

According to a press release published July 1, ASI Global Standards announced the launch of their newest audit standard: the Cannabis Safety & Quality Scheme (CSQ). The scheme is built around ISO requirements and the Global Food Safety Initiative (GFSI) requirements.

With input from a number of stakeholders in the cannabis space, the CSQ scheme is designed for the cannabis industry and by the cannabis industry. Each standard was developed by industry professionals and stakeholders, like growers, manufacturers and processors, to meet market, consumer and regulatory requirements from seed-to-sale.

The CSQ scheme is built on four standards:

Growing and Cultivation of Cannabis Plants
Manufacturing and Extraction of Cannabis
Manufacturing and Infusion of Cannabis into Food & Beverage Products
Manufacturing of Cannabis Dietary Supplements

There is a public comment period in effect now, and those wishing to provide input have until July 31 to do so. If certification bodies or accreditation bodies want to find more information and get involved in the CSQ certification or accreditation process, they are encouraged to reach out via email at info@csqcertification.com.

Originally Posted on CannabisIndustryJournal.com

ASI GLOBAL STANDARDS ANNOUNCES THE LAUNCH OF ITS NEW CANNABIS SAFETY & QUALITY (CSQ) AUDIT STANDARDS

The CSQ Scheme and Audit Requirements go live today for public comment until July 31, 2020.

July 1, 2020: Today CSQ is officially announcing the launch of its website and the Cannabis Safety & Quality Scheme which is built around both ISO Requirements and the GFSI Benchmarking Requirements. CSQ was made for the cannabis industry, by the cannabis industry. Each standard has been developed by industry professionals and stakeholders to meet industry, customers, and regulatory requirements from seed-to-sale.

Cannabis Safety & Quality (CSQ) Standards:

Growing and Cultivation of Cannabis Plants
Manufacturing and Extraction of Cannabis
Manufacturing and Infusion of Cannabis into Food & Beverage Products
Manufacturing of Cannabis Dietary Supplements

Visit www.CSQCertification.com today to view the CSQ Scheme Requirements and the four CSQ Standards launching in the coming months. Provide your input on the cannabis industry’s most trusted safety & quality certification until July 31^st.

If you are a Certification Body (CB) or Accreditation Body (AB) wanting to find out more information about how you can get involved in the CSQ Certification or Accreditation process, please email info@csqcertification.com.

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