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In Missouri, the implementation of a Quality Management System (QMS) is a critical requirement for cannabis production facilities, as outlined in the state's regulations. The purpose of a QMS is to ensure that facilities maintain high standards of quality and compliance throughout their operations. Below, we will provide a detailed overview of the QMS requirements, including the regulatory framework, implementation guidelines, and practical implications for licensees. Regulatory Framework The requirement for a QMS is specified in 19 CSR 100-1.100(4)(D), which mandates that all licensees implement a QMS using a published standard within one year of receiving department approval to operate. The chosen standard must be applicable to the facility type and emphasize regulatory compliance. Acceptable standards include those offered by recognized organizations such as the International Organization for Standardization (ISO), ASTM International, Cannabis Safety and Quality, or the Foundation of Cannabis Unified Standards. Implementation Guidelines Selection of a Standard: Licensees must select a QMS standard that aligns with their specific operations. For example, ISO 9001 is a widely recognized standard that focuses on quality management principles, including customer focus, leadership, and continual improvement. Documentation and Procedures : The QMS must include comprehensive documentation of all processes and procedures. This includes standard operating procedures (SOPs) for cultivation, manufacturing, and distribution, as well as protocols for handling non-conformities and corrective actions. Training and Competency : Employees must be trained on the QMS and demonstrate competency in their roles. This ensures that all staff members understand the quality standards and their responsibilities in maintaining compliance. Monitoring and Measurement : Facilities must establish systems for monitoring and measuring key performance indicators related to quality. This includes regular audits, inspections, and testing to ensure that products meet safety and quality standards. Continuous Improvement : A core component of the QMS is the commitment to continuous improvement. Facilities must regularly review their processes and make necessary adjustments to enhance quality and efficiency. Practical Implications for Licensees Regulatory Compliance: Implementing a QMS helps ensure compliance with Missouri's cannabis regulations, reducing the risk of violations and penalties. It also prepares facilities for inspections and audits by regulatory bodies. Product Quality and Safety : A robust QMS enhances product quality and safety, which is crucial for consumer trust and market competitiveness. It ensures that products are free from contaminants and meet all labeling and packaging requirements. Operational Efficiency : By standardizing processes and procedures, a QMS can improve operational efficiency, reduce waste, and lower production costs. This can lead to increased profitability and sustainability for the business. Risk Management : A QMS provides a framework for identifying and mitigating risks associated with cannabis production. This includes risks related to product recalls, supply chain disruptions, and regulatory changes. Scenario-Based Example Consider a cultivation facility that has recently received its license to operate. To comply with the QMS requirement, the facility selects ISO 9001 as its standard. The facility then develops SOPs for each stage of the cultivation process, from seed selection to harvest. Employees undergo training to understand these procedures and their role in maintaining quality. The facility also implements a system for regular testing of soil and water quality, as well as environmental conditions such as temperature and humidity. By continuously monitoring these factors, the facility can quickly identify and address any issues that may affect product quality. Summary In summary, the implementation of a Quality Management System is a mandatory requirement for cannabis production facilities in Missouri. It involves selecting an appropriate standard, documenting processes, training employees, and continuously monitoring and improving operations. A well-implemented QMS not only ensures regulatory compliance but also enhances product quality, operational efficiency, and risk management. As regulations evolve, facilities must remain adaptable and committed to maintaining high standards of quality and compliance.

Originally posted by David Vaillencourt, CEO, The GMP Collective September marked a pivotal moment for the cannabis and hemp industries. Senator Ron Wyden introduced the Cannabinoid Safety and Regulation Act (CSRA), reinforcing the industry’s move toward federally mandated safety standards. Simultaneously, the National Academies of Sciences, Engineering, and Medicine (NASEM) released a comprehensive report emphasizing the urgent need for standardized practices . The message is clear: compliance with Good Manufacturing Practices (GMPs) and ASTM International standards is no longer a nice to have—it is the bare minimum to ensure product credibility and safety. The CSRA: Reinforcing the Path Forward While the CSRA doesn’t establish new precedents, it significantly reinforces what industry advocates and previous legislative efforts have been emphasizing: the necessity for standardized safety and quality practices in cannabinoid products. This alignment with global regulatory practices brings the cannabis and hemp industries in line with how other consumer products are regulated worldwide—through adherence to GMPs. Key highlights of the bill include: Mandatory GMP Compliance : All products must be manufactured in facilities adhering to GMP standards, ensuring consistency and safety. ASTM Standard Symbol Requirement : Products containing intoxicating cannabinoids must display the ASTM standard symbol , promoting transparency and uniformity . Facility Registration and Inspection : Enhanced oversight through mandatory facility registration and regular FDA inspections. Comprehensive Labeling : Strict labeling requirements to provide accurate consumer information. Emphasizing Standards in the NASEM Report In tandem with legislative developments, the NASEM report titled “Cannabis Policy: Public Health and Health Equity” underscores the critical need for standardized practices. The report calls for increased education, research, and the adoption of established standards to ensure product safety and efficacy. The report calls for adoption of monographs (a type of standard) published by the U.S. Pharmacopeia (USP), who works closely with ASTM’s Cannabis Committee on developing model standards for the industry. As the Vice-Chair of the ASTM D37 Committee on Cannabis , I’ve witnessed firsthand the dedication to creating robust standards that address both quality and safety across all aspects of cannabis and hemp products. “Many C15 customers understand that integrating GMP and ASTM standards into their quality programs today is not only essential for compliance but also key to long-term growth and success,” says Sean Samuel of C15 Solutions , an eQMS solution provider for the cannabis industry. “By acting now, they are ensuring a smoother transition into federal oversight while building a competitive advantage. Commercial benefits include unlocking new market opportunities, such as expansion into Europe, attracting new investment, and future-proofing their businesses in a rapidly evolving industry. It’s worth noting that most consumer packaged goods, dietary supplement, and pharmaceutical manufacturers also adhere to GMP and ASTM standards, which means adherence to these standards inherently makes a cannabis operation a more attractive partnership or acquisition target.” The Writing Is on the Wall With over a dozen states already integrating ASTM standards into their cannabis regulations, federal legislation like the CSRA underscores the inevitability of nationwide adoption. This alignment not only standardizes practices but also brings the industry in line with global consumer product regulations. The potential rescheduling of cannabis by the Drug Enforcement Administration (DEA) adds further urgency. Rescheduling would bring cannabis closer to mainstream regulations for consumer products, making compliance with GMPs and ASTM standards essential. A Call to Action for Operators For cannabis and hemp companies, the time to act is now. Implementing GMPs and ASTM standards is no longer a strategic advantage—it’s a necessity for survival in a rapidly evolving market. This applies across the board: Cultivation : Standardized growing practices to ensure consistency and purity. Laboratory Testing : Rigorous protocols to validate product safety and potency. Manufacturing : Adherence to GMPs to maintain quality throughout the production process. Packaging and Labeling : Compliance with new labeling requirements to meet consumer transparency demands. Expert Support Is Available At The GMP Collective, we specialize in guiding companies through the complexities of adopting these standards. Our expertise ensures that your products, processes, and facilities are not only compliant but positioned for long-term success in a regulated market.

The Prevalence of Consumer Complaints in the Cannabis Industry The legal cannabis market is experiencing rapid growth, particularly in North America. As of August 2024, 25 U.S. states have legalized cannabis for recreational use, and many others allow cannabis for medical purposes. Similarly, Canada's legal market continues to grow since the 2018 legalization. However, as more consumers turn to legal cannabis products, the volume of consumer complaints has risen in tandem. Several factors contribute to this increase in complaints. As cannabis products become more accessible, consumers have higher expectations for product quality, consistency, and safety. Furthermore, the legalization of cannabis has brought in a wider range of consumers, many of whom are less familiar with the potential risks and variability of cannabis products, leading to heightened concerns when products do not meet their expectations. Common Complaints in Legal Cannabis Products Consumer complaints in the legal cannabis market cover a broad spectrum, but some of the most frequent issues include: Product quality concerns : Consumers often complain about the perceived or actual quality of cannabis products. This includes issues like mold, contamination with pesticides, and inconsistency in potency levels. Labeling inaccuracies: Mislabeled products, particularly in terms of THC and CBD content, are a common source of complaints. Consumers are rightfully concerned when the product they purchase does not match the advertised potency or ingredients. Packaging issues: Complaints about cannabis packaging are also common, with some consumers finding the packaging difficult to open, while others raise concerns about its environmental impact. Adverse effects: Unexpected side effects from cannabis products can lead to consumer complaints, especially when the products do not provide adequate warnings or instructions for use. Customer service grievances: Slow response times, poor handling of product returns, or inadequate customer service can also lead to negative consumer experiences. A Case in Point: California’s DCC and Pesticide-Laden Cannabis Products A particularly significant example of the prevalence of consumer complaints in the cannabis industry occurred in California, one of the largest and most heavily regulated cannabis markets in the world. In 2020, the California Department of Cannabis Control (DCC) received a wave of complaints from consumers about cannabis products that were allegedly contaminated with pesticides. These complaints prompted an investigation by the DCC, which ultimately led to the discovery that several cannabis producers were using illegal pesticides in their cultivation processes. The investigation revealed that multiple batches of contaminated cannabis products had reached the market, putting consumers at risk of exposure to harmful chemicals. In response to these complaints and the subsequent investigation, the DCC enforced strict penalties on the non-compliant businesses, including product recalls and fines. This case highlights the significant role that consumer complaints can play in uncovering non-compliant practices within the cannabis industry and driving regulatory enforcement. The Impact of Consumer Complaints on Cannabis Operators The rise in consumer complaints poses several risks for cannabis operators, particularly in a highly regulated industry like cannabis. The impact of these complaints can be wide-ranging, affecting everything from a company's reputation to its bottom line. Reputational Damage In today’s digital age, consumers have more avenues than ever to share their experiences and voice their concerns. Social media platforms, cannabis review sites, and online forums are filled with consumer feedback, both positive and negative. Reddit, for example, seems to be a popular forum for cannabis product feedback. When complaints about product quality or safety arise, they can quickly spread across these platforms, damaging a brand's reputation. For cannabis operators, negative reviews can have long-lasting effects on customer loyalty. Consumers are likely to steer clear of brands that have been associated with safety issues, poor quality, or negative experiences. In an industry as competitive as cannabis, where brand differentiation is key to success, maintaining a positive reputation is crucial. Cannabis is still a relatively nascent industry and as such many brands haven’t yet built a foundation of credibility quite yet, which means that a) product complaints can really set you on the back foot without brand equity to fall back on but it also means b) there is an opportunity to build consumer loyalty from your response to complaints . Easier said than done, we will explore this in more detail shortly. Regulatory Implications Cannabis operators are subject to stringent regulations, and failing to address consumer complaints can lead to serious regulatory consequences. In the United States, for example, the Food and Drug Administration (FDA) has issued warnings to several companies selling cannabis-derived products (particularly CBD products) due to consumer complaints about mislabeling or false claims about product benefits. In cases where complaints reveal violations of regulatory standards, cannabis operators may face penalties such as fines, product recalls, or even the suspension of their licenses. The DCC example mentioned earlier demonstrates the regulatory risks operators face when they fail to address quality issues brought to light by consumer complaints. Financial Losses Consumer complaints can also have a direct impact on a company’s finances. Negative experiences can lead to lost sales, as dissatisfied customers choose not to make repeat purchases. In addition, when complaints result in product recalls or regulatory penalties, the financial costs can be substantial. Companies may need to halt production, issue refunds, or invest in corrective actions, all of which can strain their resources. The Formula for Handling Complaints: Compliance x Speed x Resolution x Reporting = Success The Importance of an Expedited Complaint Response Process Given the potential consequences of consumer complaints, it is essential for cannabis operators to respond quickly and effectively. A slow or inadequate response can exacerbate the problem, turning a small issue into a larger one. Building Customer Trust and Loyalty One of the most important reasons for addressing complaints quickly is the impact it can have on customer trust and loyalty. When consumers feel that their concerns are being taken seriously and that the company is committed to resolving the issue, they are more likely to continue purchasing from that brand. In contrast, a slow or dismissive response can drive customers away, leading to lost business and negative word of mouth. Mitigating Legal and Regulatory Risks For cannabis operators, speed is not just about customer satisfaction—it’s also about compliance. Regulatory bodies like the FDA, Health Canada, and the DCC require companies to respond to complaints in a timely manner. Failing to do so can lead to investigations, fines, and other penalties. By establishing a robust complaint response process, operators can reduce the risk of regulatory action and ensure they remain compliant with industry standards. Reducing the Risk of Escalation A swift response to consumer complaints can prevent small issues from escalating into larger problems. For example, a complaint about mislabeled THC content can be resolved through a refund or product replacement, but if left unaddressed, it could lead to regulatory scrutiny, fines, or a full product recall. Addressing complaints promptly can help operators resolve issues before they spiral out of control. Operational Efficiency Handling complaints efficiently can also improve overall operational efficiency. By addressing issues quickly, operators can identify potential problems in their production or supply chain early, allowing them to make necessary adjustments before more products reach consumers. This proactive approach can lead to better quality control, fewer recalls, and a more streamlined operation. Leveraging eQMS Solutions for Complaint Handling One of the most effective ways for cannabis operators to manage consumer complaints is by leveraging electronic quality management systems (eQMS), like C15 Solutions . These digital tools can streamline the complaint handling process, ensuring that issues are addressed quickly and compliantly. Automating Complaint Receipt & Tracking An eQMS streamlines the process of receiving, logging, tracking, and resolving complaints. By centralizing complaint data in a digital system, operators can ensure that all complaints are documented and addressed in a timely manner. Automated tracking also allows for greater transparency, making it easier for operators to monitor the status of complaints and confirm timely resolution.

Employee Health & Safety (‘EHS’) is becoming an increasingly important topic in the cannabis industry. The Occupational Safety and Health Administration (‘OSHA’) is a vital agency within the United States Department of Labor. Its primary purpose is to ensure safe and healthy working conditions for employees by setting and enforcing standards and by providing training, outreach, education, and assistance. Unfortunately, back in 2022 there was a significant incident involving an employee's death from inhalation of ground cannabis dust at a Multistate Operator (MSO) facility. Reports, in the public domain, show OSHA investigators found the employee died from occupational asthma due to exposure to ground cannabis. One finding was that workers weren't provided enough information and training on the hazards involved in the production and grinding process. This incident illustrates the significance of both everyday hazards inside a cannabis facility as well as the responsibility of cannabis companies to prevent these incidents from occurring. In this blog, we will outline typical hazards as well as tools to assist cannabis operators in responding to OSHA inspections or similar agencies in other jurisdictions such as CCOHS (Canada) and EU-OSHA (Europe). To give you an idea of the scope of OSHA, the org., along with its state partners, operates with approximately 1,850 inspectors responsible for the health and safety of 130 million workers across more than 8 million worksites. This ratio equates to about one compliance officer for every 70,000 workers. In fiscal year 2023, OSHA conducted a total of 34,267 federal inspections​ ( OSHA )​. Within the cannabis industry, it has been observed that OSHA's involvement is likely to increase as the industry becomes more mainstream. This is particularly true in states like Colorado, where cannabis cultivation has become a significant industry. OSHA violations and fines, while not commonplace in the cannabis space, are expected to become more frequent, especially regarding issues like pesticide use in cultivation operations. To be very clear, despite the cannabis industry’s status as a federally illegal industry, it is very much still responsible for adhering to and complying with OSHA regulations ( https://mjbizdaily.com/osha-intervention-cannabis-industry-qa-jolene-donahue/ ). The power of OSHA investigators ranges from fines to even stop work orders. Investigators have actual fact-finding powers under the laws and if, as an employer, you can not prove the actual facts on the ground at the time of any incident, then there is little power to mitigate the OSHA fact findings.

Introduction Welcome to the dynamic world of the cannabis industry, where the quality of the final product is much more than meets the eye. In this blog, we're going to explore what really goes into making elite cannabis. For the purpose of this blog, we’re going to deconstruct ‘quality’ into two forms – front-end quality (consumer facing attributes) and back-end quality (production ®gulatory attributes). At a high-level, we can think of front-end quality as how it smokes/affects us, and we can think of back-end quality as the safety & consistency associated with the product. This deconstruction and exploration will take us from the visible traits like the plant's appearance, potency, aroma, and purity to the behind-the-scenes action at the growing facility itself - the regulations, growing techniques, quality processes, and laboratory test results. It's not just about growing a plant; it's about a detailed and careful process that ensures what ends up in your hands is safe, consistent (or at least as consistent as possible) and of the highest standard. In other words, growing high quality cannabis is both an art and a science. Section 1: Front-End Quality First, we’re going to tackle front-end quality. Broadly speaking, front-end quality attributes are perceived more by end consumers. In no particular order, here are the most common front-end quality attributes that consumers typically use to evaluate their product: Appearance → We’ve also heard the term ‘bud integrity’ used to evaluate the appearance of flower. Is the bud whole & dense, or does it have noticeable gaps? Has it been trimmed cleanly or sloppily? The color of the flower is also important – not that any one particular color is better, rather, does the color line up with genes of that particular cultivar? Finally, visual inspection of trichomes will tell a story as well. Generally speaking, the more the better (i.e. more ‘frostier’ looking). That said, an abundance of trichomes doesn’t tell the whole story; are they clear, milky white, or amber-ish/yellow? Clear means the flower may have been harvested too early and hasn’t been properly cured. Amber/gold means the flower was harvested too late and THC degradation has begun. Milky white = just right! Potency → Much could be written here and potency is often subjective, but what is absolutely true is that there is much more than just the stated THC% telling a story here. When it comes to cannabis flower, there will always be an ‘entourage effect’, where many cannabinoids (as much as 100s!) will interact with each other to deliver a specific effect. As the wellness product market develops, consumers may be more interested in minor compounds like CBN or CBG rather than THC. Terpenes may also impact how potent we feel a product is. Bottom line, don’t evaluate the quality of flower on THC % alone. Aroma → Often described as ‘head’ – the only rule of thumb that applies here is, the stronger the better! Much like color however, the aroma of flower should be specific to the genetics it came from. This is also where terpenes come into play. The higher the % of terpenes, the more ‘flavor’ a patient/consumer will taste. Like many front-end quality attributes, aroma is subjective and certain terpene profiles may appeal more to different consumers. Purity → It goes without saying that a contaminant-free product is the desired outcome from a safety and quality perspective. The presence of powdery mildew (or ‘PM’, a white, powdery looking substance on cannabis flower) indicates a serious quality issue. It doesn’t necessarily mean it’s not safe to consume (though we wouldn’t recommend it), but it DOES mean the plant was sick and PM will adversely impact the purity and potency of the plant. Section 2: Back-End Quality There are a LOT of considerations when it comes to back-end quality. For instance, different cultivation techniques can influence flavour, potency and even how the flower smokes. Furthermore, the science of processing can have profound impacts on the preservation or degradation of final derivative products. Without getting prescriptive re: superior cultivation & processing techniques, (indoor vs outdoor, organic vs. non-organic, different post-harvest processes etc.) what we will say is that the formula for back-end quality could look something like genetic potential x grower expertise x quality assurance. Genetics are the blueprint for flower. It goes without saying that bad genetics will seriously handicap your flower right out of the gate. Doesn’t matter how talented your grower is or how buttoned-down your QA team is, poor genetics = poor quality product. Assuming you have good genetics and cultivation expertise (that best suits the facility), there is still the onerous task of building a QA team and implementing QA at the enterprise level. To be clear, QA is very different from QC, which is typically a single step towards the end of production whereby the final product is determined to have met or not met an internal quality specification. This would be considered ‘table stakes’, and is by no means a differentiating factor when it comes to enterprise quality. To get a better understanding of how truly ‘enterprise’ quality assurance can be, we will highlight a few areas which are often overlooked: Preventative Measures → T his includes everything from the selection of genetics to control of environmental conditions (light, temperature, humidity), soil & nutrient management, management of hazards & critical control points, and especially supplier qualification. As cannabis supply chains expand, so to does the risk to quality as one weak link in the chain can adversely impact the end product. Trust is KEY when it comes to supply chain partners. Compliance and Regulations → Authorities and regulatory bodies demand adherence to regulations and audit your processes involving the back end of quality. Some states now have provisions that make having a quality management system in place to do just this. As de-scheduling becomes more of an expectation, this form of oversight will favor those who build brands based on the front and back-end approach to safety and quality. Those that cut corners or believe “quality does not sell” will not have a sustainable brand as regulations evolve. Lab Testing → C onsidered a hot topic today in light of ‘THC inflation’ debates, the burden of testing does not entirely fall on third party testing laboratories. QA are usually responsible for the ‘sampling’ process which can not only influence testing outcomes but can also lead to wider discrepancies between potency claims made on a label, ultimately leading to customer dissatisfaction when they are not getting the product consistency they desire. This is especially true for medical patients that may sometimes require specific levels of potency. Furthermore, regardless of COA pass/fail results, QA teams should be tracking test results for individual analytes in order to do a proper trend analysis and ensure finished products are meeting their own internal specification as well. This best practice drives product consistency. Section 3: Connecting Front-End and Back-End Hopefully this blog has given you a more complete picture of quality in cannabis. The journey of cannabis flower from seed to consumer is a long one and consumers are often only privy to the post-harvest journey. Back-end quality attributes like genetics selection , along with the strength of your growing and quality assurance teams will absolutely impact the front-end quality attributes that consumers typically ‘grade’ their flower by. Connecting the front end and back-end does not require multiple solutions or confusing array of unintegrated platforms. It does require an approach that aligns the front with the back -end quality brand attributes in an easy and efficient (low cost) manner. Of course, any business is resource-constrained and cannabis is no exception – in fact, one could argue it’s even more resource constrained that other regulated sectors like food & beverage or pharma given the tax burden and relative nascency of (constantly evolving) cannabis regulations. As such, it’s important to be as innovative as possible when it comes to managing the back-end of your operation. Here is a shortlist of some examples of innovations in cannabis QA: Advanced Analytical Testing Techniques → Advances in next-generation sequencing as well as spectroscopy and chromatography allow for more frequent and comprehensive testing Cultivation & Harvesting Innovations → Automated climate control & monitoring systems as well as leveraging data analytics via IoT sensors ensures real-time quality management + better informed decision making Digitized Quality Management Systems → D igitizing and automating an entire Quality Management System will save massive amounts of time all the while ensuring adherence to internal controls and external regulations alike. This results in a more compliant and more consistent product. Furthermore, using a system like C15 Solutions that comes ready to integrate into complimentary systems like your ERP , S2S , environment controls , or even LIMS enables an operation to achieve true ‘enterprise’ quality assurance, while dramatically lowering associated production costs like waste, re-work, audit observations/penalties, recalls, etc. A brand needs to build trust in the consumer and this best comes from holding front-end and back-end standards to the level of your brand attributes. We encourage readers, be they facility managers, budtenders or consumers, to start asking more back-end quality questions to get the complete picture of the product they produce, sell or consume. Product education is a big theme for a sector fresh out of prohibition and, in our opinion, back-end quality doesn’t get the attention it deserves!

The answer, my friends, is blowing in the wind (Bob Dylan). Almost to a person, the sector would prefer the FDA/DEA to remain out of the regulation of even medical cannabis and would want the full de-schedule option. This is extremely remote since the Department of Health and Human Services (“DHHS”), which houses the Federal Drug Administration (“FDA”), sent a private recommendation to the Drug Enforcement Agency (“DEA”) to reschedule cannabis to category III. Category III means it is less subject to abuse harms than I and II drugs and substances. The Congressional Research Services Report, Sept 13, 2023, stated that the Schedule III category would mean “significant implications for state medical purposes but fewer for state recreational programs.” The report neglected to speculate on what these implications might look like. The report also stated that the DEA, to its knowledge, has never rejected an FDA recommendation on rescheduling.

Traceability is a fundamental element in ensuring product quality, safety, and compliance. Whether it's cannabis, pharmaceuticals, or food and beverages, being able to track and document the entire production process is essential. With advancements in modern technology, traditional paper-based systems are gradually giving way to more sophisticated and efficient solutions. One revolutionary development in this realm is the adoption of Electronic Batch Records powered by electronic Quality Management Systems (eQMS). What are Batch Records? A batch record serves as the life history of a product batch, documenting all processes and steps it undergoes to become the final product. It includes essential information such as dates, growth stage transitions, location changes, nutrient application, Integrated Pest Management (IPM) tasks, and all cultivation and processing steps outlined in Standard Operating Procedures (SOPs). It also must include any quality-related issues during the production process - whether there was an unplanned deviation, an issue with input (raw) materials, or even testing of the final product (i.e. an out-of-spec Certificate of Analysis or ‘COA’). For a robust quality assurance program, it is crucial to ensure that batch records are exceptionally detailed. However, creating such detailed batch records demands significant time and effort from both Quality Assurance and Operations teams, potentially causing delays in batch release and overall production timelines. QMS streamlines these efforts without compromising quality or compliance. Plus, without linking your executed batch records to the master batch record in your library, there is also a risk of not referencing the correct version. The Evolution of Batch Records: From Paper to Electronic For decades, industries have relied on paper-based batch records to document the step-by-step processes involved in manufacturing products. While these records served their purpose, they were not without limitations. Paper-based systems were time-consuming, error-prone, and challenging to maintain, especially in companies dealing with high production volumes. The emergence of electronic systems began to transform these challenges into opportunities. eQMS offers a centralized platform for document control, training, deviations, and other quality processes - becoming a game-changer in terms of traceability! C15 Solutions consolidates key information such as sanitation records, quality investigations, COA results, supplier corrective action requests (‘SCARs’) and equipment calibration records. The platform’s Automated COA Analysis provides an instant pass or fail result, accompanied by a visual trend analysis that facilitates the batch-release process, ensuring conformity with target specifications.

The significance of industry standards within the cannabis sector cannot be emphasized enough, as they establish the market as legitimate and trustworthy. By upholding these standards, the sector not only gains credibility but also opens the door to further regulatory acceptance and improved levels of quality, safety, and consumer satisfaction, which ultimately, fosters sustainable, long-term growth. Let's delve into the significance of industry standards and the efforts being made to establish them in the cannabis sector. The Importance of a Shared Vision Establishing industry standards requires collective efforts and collaboration among industry leaders, regulatory bodies, and organizations. One prominent organization working towards this goal is ASTM International's Committee D37 on Cannabis . This committee, formed in 2017, is dedicated to developing and maintaining standards for cannabis, its products, and processes - it was a natural fit for C15 Solutions! C15 has recently joined the committee and will be actively contributing to the development of industry standards. Not only will C15 be contributing to standard development by sharing best practice workflows, but the committee’s expertise and best practices will also help C15 refine customer workflows as standards evolve. This type of collaboration ensures that standards align with industry needs, driving continuous improvement in product quality, safety, and compliance. Revolutionizing Cannabis Operations: How ASTM D37's Guide Can Transform the Industry In a groundbreaking move, ASTM D37 has acknowledged a pressing need for Quality Management Systems in the cannabis industry . Their latest proposal aims to establish a comprehensive guide that will revolutionize the way organizations involved in cannabis consumer products operate. By encompassing all aspects from cultivation to distribution, this guide seeks to foster robust Quality Management Systems in both the medicinal and recreational sectors. With the introduction of this guide, regulatory bodies now have a powerful tool to ensure compliance and guarantee the production of high-quality and standardized goods. In addition, companies in all verticals across the cannabis supply chain would now have a framework to develop their Internal Quality systems to meet market demands and regulatory bodies. This major step aligns the cannabis industry with other heavily regulated sectors, such as food and pharmaceuticals, where consumer safety and product consistency are paramount. Exciting developments have also taken place on the state level, with New York and New Jersey taking significant strides in cannabis production regulation. Both states have now mandated that producers operate under a Quality Management System, with strict requirements for record-keeping and traceability throughout the cultivation and manufacturing stages. Missouri is another state that has mandated cannabis businesses implement a Quality Management System - by requiring this, the state ensures the industry is operating in a safe, responsible, and consistent manner, while also setting cannabis operators up for long-term success. This underscores the importance of implementing standardized processes, especially in the absence of federal regulation. How Standardization Gaps Impact Cannabis Operators While some progress has been made, there are still numerous areas that lack standardization. Key aspects such as quality event procedures, training processes, lab testing methods, waste recycling, and banking procedures face the need for standardized approaches. These aspects currently see challenges like inconsistent testing results, inadequate training procedures for quality management professionals, unclear classification and production methods, difficulties in accessing capital, and rising insurance premiums. The absence of uniform guidelines and standardized rhetoric contributes to inefficiencies, operational challenges, increased risks, and higher expenses for cannabis operators. While the industry awaits comprehensive standardization, operators are left grappling with a fragmented landscape. To paint a picture of how difficult it is to scale, many states have different marketing regulations, production standards, AND testing requirements. However, Quality Management Systems can provide a solution by harmonizing certain processes and procedures across operations while allowing for customization where needed. Quality Management Systems not only enable operators to exercise control over their operations but also accelerate the standardization process once regulatory frameworks are established - win-win! Learn how C15 impacted Vantage Hemp Co. when the company adopted its eQMS platform. The Building Blocks of a Responsible and Competitive Cannabis Market The benefits of standardization in the cannabis sector are numerous and can have a positive impact on consumers, businesses, and regulatory bodies. Here are some key advantages: Enhancing Product Quality and Safety Implementing robust industry standards helps maintain uniformity and minimize variations in product quality. By setting guidelines for cultivation, processing, manufacturing, and distribution, these standards ensure that cannabis products meet specific quality benchmarks. This promotes consistency, reduces defects, enhances the overall customer experience, and safeguards the public by reducing the potential health risks associated with the consumption of contaminated products. Building Consumer Trust and Confidence Consumers need assurance that the products they purchase are safe, reliable, and of high quality. Industry standards serve as a mark of quality and consistency, enabling consumers to make informed decisions. When consumers see that a product adheres to established standards, they feel confident in its safety and efficacy. This, in turn, fosters brand loyalty and encourages repeat purchases. Fostering Research and Innovation By providing a common language and framework, these standards facilitate collaboration among businesses, researchers, and regulatory bodies. They enable the collection of reliable data, which can be used for comparison and analysis. This scientific and industry advancement is instrumental in driving innovation, promoting best practices, and pushing the boundaries of knowledge in the cannabis sector. Driving Growth and Legitimacy Standardization creates a level playing field for businesses, encouraging responsible practices and fair competition. It also attracts investment and partnerships from stakeholders who value professionalism and compliance. The Roadmap to Sustainable Growth The cannabis industry's growth and potential can only be fully realized when standardization is prioritized. The implementation of a comprehensive Quality Management System is crucial to achieving these goals, enabling operators and regulators to navigate the industry with greater efficiency and confidence while consumers can expect reliable and safe products. By partnering with forward-thinking technology providers, such as C15, cannabis operators can leverage standardized and automated methods to improve quality, consistency, and compliance (while lowering their operational costs!). Choosing the right vendor is a critical process that demands careful consideration and we’re here to help you learn more. The cannabis industry is poised for a transformation that will elevate it to new heights - book a demo with C15 today.

NEW YORK, June 27, 2023 -- C15 Solutions Inc. (“C15”) and AlphaRoot have formed an innovative partnership that enables cannabis operators to access competitive insurance premiums while gaining a comprehensive review of their insurance and quality programs. C15 offers an electronic Quality Management System (‘eQMS’) platform designed to enhance quality and compliance while minimizing operating costs in the cannabis industry. While AlphaRoot is more than an insurance broker; specializing in comprehensive risk management solutions tailored to its clients' needs. Both offerings align closely with the values of each company; risk mitigation and quality management. Just like C15, AlphaRoot is committed solely to serving the cannabis sector. “We are extremely excited about this very natural partnership,” said Sean Samuel, VP of Sales and Marketing at C15. “Proper compliance and risk management should have tangible benefits and now C15 customers and the industry at large can benefit from superior risk ratings and better access to insurance at lower costs.” “When considering strategic partnerships, we look for alignment in culture, service, and expertise. Above all, we look for partnerships that will have a positive impact on our clients. The collaboration between AlphaRoot and C15 not only meets but exceeds all of our desired characteristics,” said Hunter Baldwin, Commercial Cannabis Risk Advisor at AlphaRoot. “The combination of C15's innovative platform, AlphaRoot's insure-tech platform (app.alpharoot.com), and the comprehensive insurance and risk management services that we provide to clients create a natural synergy. This partnership is expected to enhance our clients' risk profiles as they continue to scale.” About C15 Solutions Inc. C15 delivers a customized eQMS (Electronic Quality Management System) platform exclusively for the cannabis sector to enhance the quality, safety and consistency of cannabis products while lowering operating costs. The company is a leading tech partner to a global customer base of operators, cultivators, processors, manufacturers of cannabis products, and labs. C15 has a proven track record of isolating and reducing the cost of quality for its customers while strictly adhering to all industry jurisdictional regulations. Visit www.c15solutions.com . About AlphaRoot Insurance AlphaRoot is a full-service insurance brokerage and advisory firm that works exclusively with the cannabis, hemp, CBD, holistic medicine, and psychedelic industries. The company has clients across the entire supply chain, from new licensees to public operators, and extends out to ancillary and capital providers. The AlphaRoot team believes that in order to stay on the vanguard for their clients, an intense focus on the challenges their clients face is a necessity. Ultimately, the AlphaRoot goal is to become a trusted source for insurance and risk management strategy and implementation, fueling their clients’ growth. Visit www.alpharoot.com .

Good Manufacturing Practices (GMP) are fundamental to maintaining the safety, quality, and consistency of products across various industries. The cannabis industry faces increasingly stringent compliance requirements to safeguard consumers and enhance product integrity. To meet these demands, cannabis operators are turning to electronic Quality Management Systems (eQMS) as an indispensable tool in achieving and maintaining GMP compliance. What is GMP? GMP is a meticulously designed framework that ensures products are consistently manufactured according to quality standards. Regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), enforce GMP regulations to protect public health and mitigate risks at every stage of the manufacturing process. GMP plays a proactive role in quality assurance, encompassing a wide range of elements including materials, premises, equipment, storage, record keeping, staff training, hygiene, complaint handling, and product development. The impact of GMP extends globally, with over 100 countries having incorporated the World Health Organization's (WHO) GMP provisions into their national medicines laws and many more countries adopting its approach as a guiding framework to establish their own national GMP requirements. Certifications such as EU-GMP (Europe), cGMP (U.S.), or Guide 104 GMP (Canada) are essential for compliance in their respective regions. Further insights can be obtained from the World Health Organization's resources on GMP. The Pathway to EU-GMP Compliance for Cannabis Operators The European Union (EU) has implemented strict regulations regarding the import and export of cannabis products, with one of the key requirements for cannabis operators to obtain EU-GMP certification. This certification process involves a comprehensive evaluation of the entire cannabis supply chain, from cultivation to manufacturing, packaging, labelling, and distribution. By imposing such requirements, the EU aims to increase consumer confidence and create a level playing field for cannabis businesses operating within its jurisdiction. A significant number of C15 Solutions’ customers have leveraged eQMS to adhere to EU-GMP regulations (while simultaneously lowering their cost of quality!). C15 has also garnered a solid reputation with EU regulatory bodies, including the Medicines & Healthcare product Regulatory Agency (MHRA) and the Therapeutic Goods Administration (TGA), who have confirmed 100% EU-GMP validation of its eQMS platform. To put it simply, if you aspire to EU-GMP status and a ‘pharmaceutical-grade or consumer packaged goods (CPG)” level of quality, you must have a document control and quality management system fully deployed. Global medical cannabis is a compliance business - see how C15 can help. Quality Variability in the U.S. Cannabis Industry: How Fragmented Regulations Impact Consumers In contrast, the United States has a more fragmented regulatory landscape for cannabis with varying standards from state to state, leading to a patchwork of different rules and quality control measures. While certain states in the U.S. have implemented stringent measures and testing requirements for cannabis products, others have relatively lenient regulations or limited oversight. Consequently, consumers are left to question which products are safe and reliably labelled - they may encounter variations in potency, purity, and contaminants depending on where they are sourced. CPG business models demand product consistency state-to-state, notwithstanding the regulations. The lack of standardized quality requirements at the federal level in the U.S. has prompted calls for more uniform regulations and harmonized standards across the country. Efforts are being made to establish federal guidelines for cannabis quality control, including testing protocols and labelling requirements. In the meantime, multi-tenant, cloud-based eQMS platforms like C15 are the remedy; they enable operators to harmonize certain processes and procedures nationally while customizing others and adhering to a variety of quality standards across the respective states. C15 also recently joined the ASTM D37 Cannabis Committee in an effort to help standardize processes and procedures across the USA (more to come on this in our next blog!). GMP Compliance Made Easy: The Role of eQMS Now, let’s explore the significance of eQMS in ensuring GMP compliance and how it benefits cannabis companies in streamlining their operations. Streamlining Document Management GMP compliance requires meticulous control and documentation of procedures, specifications, and records, proving eQMS to be invaluable by centralizing and digitizing the entire document management process. It eliminates the need for manual paperwork and reduces the risk of errors or lost documents. With eQMS, cannabis operators can effectively manage documents, ensuring version control, accessibility, and traceability. Ensuring Effective Training and Competence Management A well-trained and competent workforce is crucial for GMP compliance. eQMS provides a platform for managing training programs, tracking employee competencies, and documenting training records. Standardized training modules can be created, progress can be monitored, and skill gaps can be identified. Automated notifications and reminders ensure timely training and certification renewals, mitigating the risk of non-compliance. Facilitating Corrective and Preventive Actions (CAPA) Corrective and Preventive Actions (CAPA) are a vital component of GMP compliance, aimed at identifying and rectifying non-conformances while preventing their recurrence. eQMS streamlines the CAPA process by providing a centralized system to record, track, and manage corrective and preventive actions. Real-time visibility into the status of CAPAs ensures effective implementation of corrective measures, minimizing risks and enhancing product quality. Enabling Change Management Change control is essential for managing and documenting modifications in processes, equipment, or systems. eQMS simplifies change management by offering a structured framework to evaluate, approve, and implement changes while maintaining an audit trail. This ensures transparency, accountability, and adherence to GMP regulations throughout the change management process. Supporting Audits and Inspections GMP compliance demands readiness for audits and inspections from regulatory authorities. eQMS plays a crucial role in preparing organizations for these assessments by providing a centralized repository of compliance-related information. This allows organizations to easily demonstrate GMP compliance, reducing the time and effort required for audits and inspections while ensuring a smooth experience. Real-Time Data Analytics and Reporting eQMS platforms generate real-time data analytics and reports, providing valuable insights into quality-related metrics, trends, and performance indicators. These analytics enable proactive decision-making, process optimization, and identification of areas for continuous improvement. By leveraging these insights, cannabis producers can enhance their compliance with EU-GMP standards and demonstrate a commitment to ongoing quality enhancement. Unlocking Sustainable Growth in the Cannabis Sector As the cannabis industry continues to evolve, GMP compliance becomes increasingly vital for maintaining product quality, consumer safety, and regulatory adherence. eQMS emerges as a crucial link in this journey. By embracing eQMS, cannabis companies can navigate the complex landscape of GMP compliance with confidence, setting the stage for sustainable growth and success in the industry. Book a demo with C15 today.