Tag Archives: certificate

July 27, 2021

The Importance of Understanding Cannabis Testing Results

By Josh Reed

Cannabis testing is important for both operators and consumers, but there are some differences in what is important to each group. Obviously, safety and efficacy are important to both. Cannabis is primarily tested for safety reasons to ensure that consumers are receiving a product that is safe to consume and accurately labeled. In addition, consumers may look for a potency they’re used to consuming or a certain terpene profile that gives them a desired effect. Cannabis operators, on the other hand, use testing results to improve their processes and to monitor product quality versus state specific regulatory requirements that could cause their products to pass or fail.

What cannabis operators need to understand about cannabis testing results

Historically, there was an education gap on the side of the operators when it came to interpreting results. The regulated cannabis industry is still quite new and cannabis operators were initially focused on getting products to market. While there was always a focus on regulatory compliance and safety, the same level of quality control that existed in other regulated industries like food production seemed to lag. That has changed as operators have become more sophisticated and are hiring experts skilled in interpreting results and quality control. For a laboratory, hiring scientists with a regulatory background offers the operators the experience needed to ensure they’re getting accurate results that are easy to understand. This has led to more meaningful collaboration between labs and operators who work together to understand what test results mean to their processes and business operations.

OGanalytical instruments. — Consumers can easily grasp high level results in the form of charts and graphs

A common problem is that some operators see testing as just a speed bump. This doesn’t have to be the case. Third-party testing is an integral part of getting safe products to consumers. Businesses need to find a lab that understands their objectives and knows how to support the manufacturing and production cycles. Establishing a testing protocol with a lab will help ensure that there are no surprises and that products can be tested and sold as quickly as possible.

Now that operators and labs are speaking the same language, the challenge becomes translating that information into a consumer-friendly format. Consumers don’t necessarily need (or want) to explore the minutiae of every tested analyte, but they can easily grasp high level results in the form of charts and graphs. Translating the testing results into an easy-to-digest format allows consumers to better understand the products they are buying.

What are the main components of test results cannabis businesses should look for?

The first and most obvious results to look for is what was tested and if any tests delivered a failing result. A failing result is determined by comparing the tested values against the state requirements. If a product has failed testing in any area, operators will need to work with the lab and their internal teams to determine exactly what the issue is and if it can be rectified. Failing of any state required test (pesticide, microbial, metals, ….) means the product cannot be sold in its current form. Depending on the state, failing results may be required to be confirmed by another lab, processed further to remove the failing contaminants or destroyed. The production cycle to grow, process and manufacture cannabis products can take anywhere from 120 to 160 days with many different processes and handlers. Despite attempts to control all the variables that impact final product quality, failing tests do occur.

EVIO labs photo — Despite attempts to control all the variables that impact final product quality, failing tests do occur.

Once businesses have passed the state-required testing, the remaining tests are focused on product characteristics including potency and terpene profile. The potency of a product measures the levels of cannabinoids and influences both production and marketing decisions. Lower potency flower may be extracted for distillate products while higher potency flower will demand a higher price and will most likely be sold as flower or processed into concentrate products. Cannabinoid profiles go well beyond just CBD and THC. Understanding the full cannabinoid profile of a product is an important factor in how it can be marketed, and how it will be used.

The terpene profile of a product is also quickly becoming just as important to medical and adult use consumers. Terpenes play a major role in the effects that consumers experience with cannabis products. In the past, consumers relied heavily on strain names to purchase products that they believed would give them the effects that they were looking to achieve. Moving forward, we believe that consumers will be more interested in a product’s terpene profile given the strong influence that terpenes have on effects. In states like Nevada, cannabis businesses put terpene profiles on their product labels and cannabis consumers are starting to select products based on terpenes rather than raw potency numbers.

What is the most important factor in cannabis testing results?

Trust is the most important factor when testing cannabis. Operators need to trust that their lab is providing consistent, accurate and timely results. Consumers need to be able to trust what they read on the certificate of analysis, and they ultimately need to trust that the products they buy will deliver the effects that they expect.

The easiest way for businesses to increase trust in their products and testing results is transparency. When there is transparency from the testing lab to the business and customers, it will help build trust and establish a brand for the long term.

Another important aspect of this process is ensuring businesses share the right information with consumers and educate them as to what it means to them. Information overload, without explanation, will only lead to confusion. It’s important to educate employees, especially those interfacing with customers, on how to interpret and explain test results in a way that consumers can understand.

It can be challenging to translate highly technical test results into consumer-friendly language but being able to do so will enable businesses to build a stronger relationship with customers. This isn’t something that businesses need to figure out by themselves. Rely on your trusted lab partners to help design and deliver easy to understand, consumer friendly certificates of analysis. Consumers want to be educated and understand what is in their products, and how the products will work for them. Trust, transparency and education will help cannabis operators strengthen relationships and continue to grow their business.

October 26, 2020

Overcoming Challenges in the Private Label CBD Industry

By Josh Epstein

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Private labelling, or white labelling, is a popular option for brands looking to enter the CBD space. This practice is where a product is manufactured by one company but branded, marketed and sold by another.

There are several companies that specialize in manufacturing end-to-end finished CBD products. They commonly provide third-party test results, certificates and data to verify the purity and potency of products created. Technically, all new brands need to do is place their label on the package and start selling! However with any new venture, establishing a successful private label CBD brand will inevitably mean various challenges need to be overcome.

Securing Quality Sources of CBD

Finding the right partners to work with is a must. The best way to source credible and trustworthy suppliers and manufacturers is to look for certifications and audits from third-party agencies. These include the Global Food Safety Initiative (GFSI), the Safe Quality Food (SQF), the United States Department of Agriculture’s (USDA) organic certification program and others.

The USDA organic certification program is a rigorous multi-step audit process to increase supply chain sustainability. Organic certification is a form of elective, self-regulation for manufacturers which consumers have eagerly welcomed into the marketplace. Look for the USDA organic seal to help identify which manufacturers are trustworthy and can produce a range of organic products.

From a consumer perspective, certifying your products as organic is an additional way to provide both supply chain transparency and increase confidence when trying new CBD products. It also provides a form of quality assurance to skeptical consumers, especially those who avidly read product labels prior to making a purchasing decision. Members of this “label reader” demographic will consistently choose organic products for the quality and transparency they provide with pure and natural ingredients.

Creating a Unique Product

Innovation and creativity will continue to be important differentiators due to the highly competitive nature of the CBD marketplace. New ingredient innovations such as water dispersible materials are big game-changers. From chewing gum to energy drinks, the opportunities for new and unique CBD products under your own private label are limitless.

There are only a handful of CBD brands who are willing, or even able, to be certified organic today. USDA certification is an opportunity for brands looking to adapt to changing consumer preferences, diversify their product offerings and invest in supply chain transparency.

In the past, product differentiators involved third-party lab testing or providing COAs — today that’s just industry standard. The USDA organic seal is becoming one of the hemp industry’s most coveted certifications because it is a product differentiator.

Building Credibility

Trustworthiness, transparency and traceability are important factors for consumers to consider when shopping for products. These factors should also be considered when producing products and while vetting vendors, partners, stakeholders and supply chain suppliers.

Credible certifications allow consumers to make informed decisions while feeling confident that they are purchasing products from reputable sources. Research has shown that today’s CBD market lacks credibility while consumers are desperately seeking comfort and are eager to purchase from trustworthy brands.

September 9, 2020

How Barcode Labeling Improves Traceability & Security

By Travis Wayne

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One of the biggest challenges that cultivators, processors and distributors face in doing business is the requirement to track the product at every step in the production process, from seed to sale. When you add the wide range of label sizes and requirements across the supply chain, labeling can feel overwhelming. While business systems such as METRC, BioTrack, MJFreeway and others are key, integrating accurate and secure barcode labeling with those systems will streamline the end-to-end process while meeting traceability requirements. Here are some things to consider, no matter what role in the cannabis supply chain you play.

Cultivation: Where Tracking and Labeling Starts

Cultivation is where the tracking process begins – integrating barcode labeling METRC, BioTrack, MJ Freeway from the start will streamline the end-to-end process

It’s crucial to implement accurate labeling processes from the beginning, whether growing for a customer or your own vertically integrated operation. The cannabis industry is faced with strict labeling regulations for a variety of cannabis products. Start with a labeling system that can integrate with METRC, BioTrack, MJ Freeway or other seed to sale software solutions. Your barcode labeling solution should also include label approval requirements, so you have role-based access and transparency with label changes and print history in case of issues or recalls. Whatever cannabis labeling regulations your business faces, label design software helps you create compliant cannabis labels throughout the supply chain, from grower to consumer.

Radio Frequency Identification (RFID) Labeling

Select regulations require growers to leverage RFID technology to track the location of the plants in their grow houses. RFID technology also enables accurate real-time inventory analysis and helps reduce manual labor costs, as well as errors that can occur with manual counting. To accurately encode RFID tags with variable plant data, be sure you are using a barcode labeling system that can enable easy RFID tag encoding that integrates data from all your business systems. Fastening RFID tags to plants across your grow house floor enables quick and easy location tracking, and RFID reading removes the need for a manual line of sight and allows hundreds of tags to be read at the same time, speeding up shipping and receiving.

Lab Testing

After a plant is cultivated, a certain percentage is sent to a lab to be tested to ensure its proper strain, weight and compound makeup. After your product has been lab tested, leverage the data from your certificate of analysis to accurately display on your cannabis product labels, including:

Pass/fail chemical testing
Final date of testing & packaging
Identification of testing lab
Cannabinoid profile & potency levels
Efficiently display lab testing results on product labels with the use of a QR code for the consumer to review the independent lab’s certificate of analysis

Processing and Production: Tracking and Labeling After the Plant Has Been Harvested

A lot of information needs to go on a cannabis label. Whether you’re producing pre-rolls, packaged flower, edibles, beverages, topicals or cartridges, your labeling software must have the capability to create a wide variety of label sizes with barcodes that encode a large volume of data, while also being fully compliant and showing consumer appeal.

Your cannabis labeling software should do the following for you:

Support database integration to populate variable data from METRC, BioTrack, and other systems
Import high-resolution artwork and leverage with dynamic barcodes and variable data
Contain barcode creation wizards for 1D & 2D barcodes
Automate weigh & print
RGB/CMYK color matching
Feature secure label approval processes, label change tracking and print history
Offer WYSIWYG (What You See is What You Get) printing
Automatically trigger printing directly from scales and scanners when cannabis is weighed

Automatically integrating data with your barcode labeling software improves regulatory compliance, security and reduces manual processes that can lead to labeling errors

Integrate labeling with your seed to sale software solution to automatically trigger label printing by an action in your seed to sale system or by monitoring a database. By integrating your label printing system with your seed to sale traceability system, you can expect to minimize errors, increase print speeds and maximize your ROI. Your business system already holds the variable data such as product names, license number, batch or lot codes, allergens, net quantity, cannabis facts, warning statements and more. By systematically sending this data to the right label template at the right time, labeling becomes an efficient and cost-effective process.

Distribution: labeling for consumer and industry demands

The ability to manage and distribute inventory efficiently is critical in the cannabis market. Warehouses and distributors need to ensure proper storage, handling and traceability of product, from the warehouse to the truck.

Leverage your labeling software to easily create:

Packaging labels
Shipping labels
Case & pallet labels
Inventory labels

If you use the same data for your documents and labels, consider moving document printing into your label design software for greater efficiency. An advanced label creation and integration software enables label and document printing standardization by allowing multiple database records to be on one file. That means when new documents or labels come into your database, your software can seamlessly integrate.

Dispensaries can benefit from integrated seed to sale labeling for traceability, speed to market

Whether you’re a small outlet or a large dispensary, you benefit from integrated barcode labeling that starts from the beginning of the process. How? When barcode labeling software is integrated with seed to sale software, product is fully traced throughout the entire process, from tagging each plant at cultivation to identifying the consumer at point of sale, and accurately communicating that data back to METRC, BioTrack and other critical systems. Some dispensaries do package raw flower onsite, which many times means manually weighing, recording and entering the weight on the label, which is a time consuming and error-prone process. Integrating weigh and print functionality with barcode software enables dispensaries to use the action of weighing raw flower to automatically trigger the label print job. The variable weight is then accurately and automatically populated on cannabis flower package labels, creating an accurate and efficient on-demand labeling process for dispensaries. With efficient labeling processes, time spent creating, correcting, approving and printing labels will be reduced, getting product on the shelves faster.

May 16, 2020

Solutions & Alternatives to Bankruptcy for Cannabis Businesses

By Richard Ormond

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A Cannabis Related Business (or CRB), whether a plant-touching operation or a provider of goods and services to plant-touching operations cannot seek protection from the bankruptcy court as it is a federal court and cannabis remains illegal at the federal level. As such, a CRB does not have the benefit of a court approved restructuring as provided by Chapter 11 of the Bankruptcy Code and does not receive the benefit of an orderly liquidation as provided by Chapter 7 of the Bankruptcy Code. However, alternatives to bankruptcy do exist and are available to a CRB.

Historical Considerations

Before the emergence of the Bankruptcy Code, businesses and their creditors had very few options available to undertake a court-supervised restructuring or liquidation other than seeking the appointment of a court neutral, typically called a receiver or special master. That “neutral” would take the business or its assets into “legal custody” or custodia legis and begin the process of dissolving the entities, selling the assets or otherwise sell the business as a going-concern. In the 1880s and 1890s with the Gilded Age coming to an abrupt halt, this process was successfully used to restructure and recapitalize the failing network of over-extended railways and rail lines, leading to the consolidation in the market that remains to this day.

Cannabis businesses can be legal and now an “essential” business but, still cannot receive the benefits of bankruptcy court.During the Great Depression, the federal judiciary established “reference” courts to deal specifically with bankrupt businesses and individuals laying the foundations for the modern bankruptcy code which is still in effect today. Many of those first precedents used to establish the bankruptcy code and rules were drawn directly from the receivership case law and receivership statutes ever-present in the historical record of common law cases and common law countries, reaching all the way back to the Courts of Chancery in Britain established soon after the Norman invasion of the British Isles in 1066.

In the United States, the equitable power of courts to initiate receiverships or other insolvency proceedings and crafting orders and decrees based on equity, as opposed as based on law or statute, is codified clearly in Article III of the United States Constitution. Today, receiverships and special masters are still utilized by state and federal courts to remedy unique circumstances where a simple bankruptcy cannot address the inequities presented in that case.

State Court Powers & Financing of Receivership Estates

State courts in particular, and California especially, have a wide body of case law supporting the equitable powers of the court, the quasi-judicial immunity of the receiver and the many equitable tools available to receivers. These powers include the negotiation and transfer of liens, with liens attaching to proceeds of sales of assets, the dissolution of a business and the establishment of a claims process akin to a bankruptcy or assignment for benefit of creditors.

One of the many overlooked powers of a receiver is their ability to bring in outside financing or capital to fund the receivership estate to maintain a business as an ongoing concern or to provide short term leverage so that assets can be properly maintained, “dusted off” and sold.

This process of bringing in new capital is typically done by the issuance of receivership certificates. These certificates are approved, ahead of time, by the court and courts can authorize that such certificates prime all other claims (including sometimes administrative claims) and that these certificates can be reduced to a security interest recorded against real or personal property.

The Mechanics of a Receivership

However, because cannabis is approved at the state level, state courts retain their equitable powers and the power to appoint a receiver over a business in need of restructuring or liquidation. There are many avenues to get to court for this benefit, but the primary path to a receivership is either through a creditor (or group of creditors) filing a lawsuit and seeking the appointment of a receiver. This scenario can be done through cooperation and stipulation but can be hostile as well. The receiver option is available and open to address the needs of insolvency for this rapidly expanding industry.Or, a legal entity, can seek dissolution protection from the state court and seek a neutral dissolution officer (a receiver) to manage that process which may include the infusion of new capital through receivership certificates, the sale of assets to third parties, the negotiation and payment of liens and claims through a claims process and the final restructure of dissolution of the legal entity in a manner similar to a bankruptcy or assignment for benefit of creditors. This voluntary petition is permitted by statute and case law and is a mechanism available to a business that is unable to file for bankruptcy protection but is in dire need of court supervision and authority to work through its insolvency problems. Further, by court order, a receiver is able to establish banking relations where a CRB may be unable.

Typically, it is recommended that any receivership filing whether by creditors, claimants or the business itself, be guided by a well-written, explicit order that outlines the parameters of the receivership, the funding requirements and limits, the rights of claimants and some sort of stay of claims against the receivership estate to give the receiver the time needed to work through all of the issues in that receivership estate. Further, outside funding can be pre-approved by the court and the priority of that funding can be established through the open process that the court provides, much akin to a debtor in possession (DIP) financing motion in bankruptcy court.

Because of the unique circumstance that CRBs find themselves in here in California, where they are a legal and now an “essential” business but still cannot receive the benefits of bankruptcy court, the receiver option is available and open to address the needs of insolvency for this rapidly expanding industry.

October 30, 2019

The Economics of Ex-Im In Europe

By Marguerite Arnold

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You have read the press releases. You may have heard about such ideas at a recent cannabis conference in and around the EU of late. Or you may have encountered new distributors coming into the game with a German presence and a decidedly interesting ex-im plan that sounds a bit, well, off the map.

No matter how geographically creative some of these plans are, the problem is that many of these ideas literally do not make economic sense. Either for the companies themselves (if not their investors), and certainly not for patients. Not to mention, truth be told, the looming price sensitivity issues in the European market that North Americans, for starters, seem to still just be waking up to.

Some Recent Examples….

Yes, exports from Denmark have been much in the news lately (including into both Germany and Poland). Truth be told, however, this makes about as much sense, economically, as importing ice to eskimos. Why? Denmark, for all its looser regulations and less-uptight approach to the cannabis discussion generally, is one of the most expensive labour markets in Europe. Fully automated production plants are one thing, but you can build those in other places too. Especially warmer climates, with lots of sunshine. German production, as it comes online, will also make this idea increasingly ludicrous.

Who on earth got on this bandwagon? It seems that the enthusiasm in the room began when Denmark began to import to Germany (where the disparities in wages in production are not so noticeable). However, lately, several Canadian companies with a Danish footprint have been eying Poland of late.

And on that particular topic – there are many who are doing the math and trying to figure out, as the alternatives get going, if even Canada makes much sense, or will in a few years.

Low Wage Markets With Sunshine Are Hotspots For European Cannabis Production

Like it or not, the European market is extraordinarily price sensitive – namely because it is not “just” consumers called patients picking up the tab but health insurance companies demanding proof of medical efficacy.

That starts, a bit unfortunately, with understanding wage economics across Europe. The warmer the climate, in other words and the further east on the map, wages drop precipitously. That is “good” for an industry looking to produce ever cheaper (but more compliant) product.

It is also good, at least politically, for countries whose elected leaders are being forced to admit that cannabis works, but are less than copacetic about encouraging local production. See Germany for starters, but places like Austria, Poland and most recently France (which has just embarked on a first of its kind medical cannabis trial).

Here, no matter the temporary buzz about Denmark, are the places that cannabis production makes sense:

Portugal: The country is a newcomer in the cannabis discussion this fall, although in truth, the seeds of this reality were sown several seasons ago when Tilray began to build its production plant in the country in 2017. They are far from the only company who has seen the light, and these days, farmers are getting hip to the possibilities. Especially if they are already exporting crops throughout Europe.

Spain: The industry that can afford GMP certification is getting going, but everyone else is stuck in a limbo between pharmaceutical producers and the strange gray market (see the patient clubs in Barcelona). That said, political groups are beginning to discuss cultivation as an economic development tool, if not sustainable food and medication strategies.

Greece: The weather is warm, and the investment climate welcoming. Of all the countries in the EU, Greece has embraced the economic possibilities that cannabis could bring. How that will play out in the next years to come is an intriguing story.

Italy: The southern part of the country in particular is ripe for cannabis investment and it’s full of sunshine. However, as many have noted, organized crime in this part of the world is a bit fierce and starts with the letter M.

Malta: The island is a comer, but does importing cannabis from here really make economic sense? There are trade routes and economic treaties tying the island both to the apparently Brexiting British and Europe. Why not, right? Just remember that along with labour, transportation costs are in the room here too.

And Just Outside The EU…

The country now (sort of) known as North Macedonia and struggling to get into the EU if France would just get out of the way is also going to be a heavyweight in this discussion for years to come. Wages, of course, will increase as part of EU membership, but in general, this country just north of Greece is going to play a highly strategic role in exports throughout Europe.

February 13, 2019

Wayland Group’s GMP Certification Begins To Clarify German Cultivation Scenarios

By Marguerite Arnold

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Wayland Group just announced that they received GMP (good manufacturing practices) and GDP (good distribution practices) certification for their Ebersbach facility near Dresden, Germany. The plant already produced 2,400 kg of CBD isolate last year.

The certifications give Wayland the right to sell directly into German and other EU markets, and more significantly, the ability to store bulk product domestically.They have, by far, the largest cultivation site now legal in the country, with distribution to not only German pharmacies, but Europe beyond that.

Wayland is also widely believed to have applied for the much-stalled German cultivation bid. With per-gram production prices at Ebersbach cited at 1.34 euros, this certainly also sends an interesting message about who might win what in the bid, and where the price of cannabis might be headed.

Currently, cannabis is being sold to pharmacies in Germany at prices almost twice the retail price per gram in Canada. In turn, this means that the “retail” price of floss (flower) is running much higher than it is in more established markets (read Canada and of course the U.S.). Point of sale prices in Germany, for example, run between $2-3,000 per month per user. That is an era that is clearly also now coming to an end.

The Cultivation Bid

With the news of Wayland’s certifications, comes an almost certainty that they will become finalists in the pending cultivation bid in Germany. Why? They have, by far, the largest cultivation site now legal in the country, with distribution to not only German pharmacies, but Europe beyond that.

If Bedrocan was the incumbent favorite to win the majority of the licenses handed out to any one firm (especially given the recent increase in cannabis allowed to be sold into Germany across the Dutch border), this places Wayland in a strong second. If Bedrocan is not involved in the bid, this news might indicate that Wayland might be the largest winner in German cultivation licenses this time around.

The plot indeed thickens.

Prices: In General, Across Europe

The firm will be providing product, no matter what the outcome of the bid, at a production price, which is in line with the widely estimated requirements of the bid itself. Winning firms must also be able to provide pricing that is competitive to each other. It is unclear where the government will set that floor, but all medical cannabis sold in Germany after that, will then be competing with that price.

Could it be that the reference price of cannabis, in other words, has just been indirectly announced with the Wayland certifications?

Then there is this wrinkle. Given that production in Germany is more expensive than other countries in Europe (see Portugal, Spain and Greece in particular), the difference in labor costs may still outweigh the costs of shipping across the continent. Or, as the market gets going, it may not. Regardless, in a country like Germany where drug prices are routinely pre-negotiated in bulk by the government, cannabis prices will start to be regulated in a way they have not in other places, notably Canada. This means that heady visions of “mark-ups” to meet a so far unmet demand are also probably not in the cards, although government supported cannabis exports might be.

Insurance “Brands” And Bulk Buys Ahead?

Then there is this intriguing wrinkle. German “public” insurance patients (in other words 90% of the population) are not always free to choose the products they use. Why not? Beyond bulk purchases by the government, insurance companies are also allowed to enter into bulk contracts with some providers, namely medical equipment manufacturers. This is sort of the same situation as visiting an “in network” provider in the United States. In other words, the equipment is free (or vastly cheaper) to the patient if the selected brand is chosen.

Could cannabis go the same route?

german flag — Photo: Ian McWilliams, Flickr

At this juncture, that is unclear. Dronabinol, the only widely available source of cannabinoids in the country until 2016, is considered more of a generic than “name brand.” So far, neither it nor Sativex were pre-negotiated drugs. This was also for a very simple reason. There were only 800 registered patients in Germany until that year. That is far under the “orphan drug” category, which in Germany is 10,000 people. At this point, there are already much higher patient numbers (some cite as many as 79,000), with the majority of treatment going to patients with chronic pain.

By definition, this means that cannabis prices here will continue to be negotiated with little room for high mark-ups as the market consolidates. The more patients there are, the more attention will be paid to ensuring that the drug becomes affordable- not just to patients, but also insurers.

There is zero chance that the government will allow German public healthcare to be bankrupted over this still stigmatized plant, no matter how medically efficacious it is.

Germany and Israel at this point, have the longest established insurance mandate for cannabis- and in the German situation, this is now just two years old. The British NHS just announced that cannabis would be covered, with Luxembourg and Poland now also in the mix. However, the place of the insurance community in this debate is also a factor to be considered into the entire conversation as it unfolds here, beyond efficacy.

Dutch insurers in fact, stopped covering the drug almost as soon as Germany announced its own experiment.

It is unlikely that Wayland is unaware of such realities. The company has former executives from AOK on its German board. AOK is one of the largest statutory health insurers in Germany and one on the front line of cannabis reimbursements for the last two years.

August 23, 2018

Documentation: Are You Prepared?

By Radojka Barycki

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Documents play a key role in the world of regulations and global standards. Documents tell a story on programs development, implementation and verification during an inspection or audit. Documents are used as evidence to determine conformance to the law or standard. However, do you know what kind of documents may be reviewed during a regulatory inspection or a food safety audit? Are you prepared to show that the implementation of regulatory requirements or a standard is done efficiently at your facility?

Inspectors and auditors will look for compliance either to regulations or to a standard criterion. Regulations and standards require that documentation is controlled, secured and stored in an area where they cannot deteriorate. Therefore, writing a Document Management Program (DMP) will help a business owner ensure consistency in meeting this and other requirements.Radojka Barycki will host a a plenary session titled, “Cannabis: A Compliance Revolution” at the 2018 Food Safety Consortium | Learn More

A well-developed and implemented DMP provides control over documents by providing a number sequence and revision status to the document. In addition, ownership for development, review and distribution of the documents are assigned to specific individuals within the company to ensure that there are no inconsistencies in the program. Documents must also have the name of the company in addition to a space to write the date when the record is generated. It is recommended to include the address if there are multiple operational sites within the same company.

There are different types of documents that serve as support to the operations:

Program: A written document indicating how a business will execute its activities. When it comes to the food industry, this is a written document that indicates how quality, food safety and business activities are controlled.
Procedures: General actions conducted in a certain order. Standard Operational Procedures (SOPs) allow the employee to know what to do in general. For example, a truck receiving procedure only tells the employee what the expected conditions are when receiving a truck (cleanliness, temperature, etc.) However, it doesn’t tell the employee how to look for the expected conditions at the time of the truck arrival.
Work Instructions: Detailed actions conducted in a certain order. For example, truck inspection work instruction tells the employee what steps are to be followed to perform the inspection.
Forms: Documents used to record activities being performed.
Work Aids: are documents that provide additional information that is important to perform the job and can be used as a quick reference when performing the required activities within the job.

Are you prepared to face document requirements now and in the future?

The inspectors and auditors base their role on the following saying: “Say what you do. Do what you say. Prove it!” The programs say what the company do. The procedures, work instructions and work aids provide information on implementation (Do what you say) and the forms become records that are evidence (prove) that the company is following their own written processes.

Regulatory requirements for cannabis vary from state to state. In general, an inspector may ask a cannabis business to provide the following documentation during an inspection:

Business License(s)
Product Traceability Programs and Documents
Product Testing (Certificate of Analysis – COAs)
Certification Documents (applicable mainly to cannabis testing labs)
Proof of Destruction (if product needs to be destroyed due to non-compliance)
Training Documents (competency evidence)
Security Programs

As different states legalize cannabis, new regulatory requirements are being developed and modeled after the pharma, agriculture and food industries. In addition, standards will be in place that will provide more consistency to industry practices at a global level. The pharma, agriculture and food industries base their operations and product safety in programs such as cGMPs, GAPs, HACCP-based Food Safety Management Systems and Quality Management Systems. Documents required during an inspection or audit are related to:

Good Agricultural Practices (GAPs)
Current Good Manufacturing Practices (cGMPs)
Food Safety Plan Documents
Ingredient and Processing Aids Receiving
Ingredient and Processing Aids Storage
Operational Programs (Product Processing)
Final Product Storage
Final Product Transportation
Defense Program
Traceability Program
Training Program
Document Management Program

In the always evolving cannabis industry, are you prepared to face document requirements now and in the future?