Tag Archives: Good Production Practices

January 8, 2020

Canadian Cannabis 2.0: Going Beyond GPP

By Lindsay Glass

One year after Canadian recreational cannabis’s historic date of October 17th, 2018, in comes Cannabis 2.0, which will see edibles containing cannabis and cannabis concentrates enter the legal recreational market. As of October 17th, 2019, there are seven classes of legal cannabis products in the marketplace, making Canada an innovative leader in this evolving industry.

The launch of cannabis edibles and concentrates into the legal market has also led to changes in the regulatory framework and the introduction of new best practices in terms of Good Production Practices (GPP). This should not come as a surprise, as these products are introducing the inclusion of cannabis and food products.

Since Oct 17th, 2019, we have seen a significant amendment to the Cannabis Regulations through the addition of sections 88.93 and 88.94, stating that holders of a license to process cannabis edibles or extracts must identify and analyze all potential hazards and have control measures in place to prevent, eliminate or reduce these hazards from occurring. Any license holder that conducts activities related to cannabis edibles, extracts or produces an ingredient used in an edible or extract must also prepare, retain, maintain and implement a preventive control plan (PCP). To indicate that cannabis edibles and extracts regulations resemble other regulated food commodities, would not be an understatement.

By having license holders establish food safety practices similar to the ones being used by federally regulated food commodities, it is allowing cannabis producers to implement a preventive approach by focusing on safety and reducing hazards in their operation.

According to the Cannabis Regulations a license holder’s PCP must include the following:

Identify all of the biological, chemical and physical hazards that could contaminate or could be at risk of contaminating any cannabis product or anything that could be used as an ingredient in producing a cannabis product. Once all of the hazards have been identified, you need to determine the likelihood of that hazard occurring
The measures to be taken to control each identified hazard. Each control measure must then describe the task involved, how the monitoring task is carried out, who will be performing the monitoring task and how often the monitoring task is carried out
A description of the critical control points, which are the steps in the process where a control measure is applied and is essential to eliminating a hazard. Next are the measures to be taken to monitor a critical control point
A description of each cannabis product produced or ingredient that will be used in a cannabis product, including extract contents, permitted & prohibited ingredients, exceptions, naturally occurring substances and uniform distribution
A description of corrective action procedures for every critical control point
A description of verification procedures

What else comes with the collaboration of these two commodities in a regulatory environment? The need for industry to adapt and move beyond the basic GPP and pharmaceutical requirements and start thinking in terms of preventative controls and food safety. By encompassing the GPP requirements, traceability, employee training and now a complete hazard analysis and preventive control plan, you have the makings of a full food safety plan. However, food safety plans can be comprehensive and difficult to manage by utilizing a manual system.

Companies that are serious about the integration of cannabis edibles and extracts into their operations, will need to implement compliance and traceability technology that will facilitate an automated system. In return, you will streamline all monitoring processes throughout the production, packaging and storage stages of the system. This is crucial to a preventive control plan. An automated solution will also help with record keeping, document management and corrective actions, as license holders deal with failures in real time to avoid negative impacts on their products.

There are many compliance software platforms available in the industry and choosing the right one for your operation is a task in itself, as not all software platforms for the cannabis industry are created equally. Although many seed-to-sale platforms handle regulatory requirements and some document management, these platforms do not see cannabis as food products, and therefore, are leaving companies with a void in this aspect of their operation. When looking for a software platform that will encompass all of your regulatory needs, pay particular attention to systems that are designed for the food industry but have adapted to cannabis. These systems will be the most dynamic when it comes to implementing preventive control plans, handling in-depth traceability with recall plans and the ability to become completely digital.

For more information on how to automate your food safety plan for cannabis edibles and extracts, please contact Iron Apple QMS to learn about our online Cannabis QMS.

October 17, 2019

A Regulatory Tsunami is Washing Over the Canadian Cannabis Industry

By Steven Burton

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On August 29, 2019, Health Canada finally published a guidance document on the official interpretation of Part 5 of the Cannabis Regulations concerning “Good Production Practices” that comes into force just seven weeks later on October 17, 2019. For those watching with the experience of the food industry, it is safe to say that few license holders fully appreciate the magnitude of the new requirements and fewer yet are prepared for what will be required in less than two weeks.

An Uncertain Road to Cannabis Compliance

Since Canada legalized recreational cannabis in October 2018, there has been considerable uncertainty about the road to compliance in this totally new legal market. Health Canada faced the daunting challenge of defining the requirements for a whole new industry, and so they were understandably silent on the issue of Part 5 until this guide was published in August.

Many larger companies eager to get their foot in the door of the multi-billion dollar industry tried to be proactive in anticipating impending government regulations by seeking Good Manufacturing Practices (GMP) certifications. This would likely have been fine under the previous regulations, which were myopically focused on ensuring that product wasn’t diverted from or to the black market. With the legalization of edibles only one year away, however, it was obvious to those in the food industry that GMP was just not going to be enough. Gentle prodding at various speaking engagements on our part wasn’t enough to convince these companies to seek higher levels of certification or at least to proactively develop the organizational culture required to support a higher-level program.

The Inevitable Necessity of Food Safety

It was clear to us that since edibles are essentially a food product, safety necessarily had to become a primary focus. This reality has, in fact, materialized in section 5 of the new guide, which outlines prescriptive requirements that are very well developed and require that companies develop a complete set of Standard Operating Procedures (SOPs) for sanitation, employee hygiene, testing, inventory, pest control and more. Furthermore, cannabis companies must be able to produce documentation that proves they are actually following these procedures.

There are many, many other requirements that also apply, but the really interesting ones are those related to hazard analysis (5.2.13) and preventive control plans (5.2.14): manufacturers who produce extracts or edibles must undertake hazard analyses on each input, processing step and traffic flow. The language will be familiar to those who have been exposed to Hazard Analysis and Critical Control Point (HACCP) methodology. HACCP is the standard in the food industry and goes far beyond simple GMP.

Very much like HACCP, license holders will be required to analyze each biological, chemical and physical hazard, determine controls, identify critical control point, along will all the validation, reassessment, verification and deviation protocols required. Interestingly, the fraud and bioterrorism hazard types that have recently been introduced for the food industry have been omitted, presumably an oversight that will be rectified in future versions.

How to Catch Up Fast with Tech

Satisfying these regulations using traditional manual methods takes months or even years in some cases. Today in Canada, license holders have only weeks to get their facilities to compliance, and the government is quick to crack down on any mistakes. The only way to possibly meet this deadline is to start yesterday and use the best tools you can find to expedite the process.

Those who have been busy implementing GMP programs are going to have to look far beyond their current objectives. Those just starting out should build with these requirements front of mind, both to satisfy inspectors and auditors and also to avoid the pain of the organizational change required to move to a higher level of quality and safety.

Ultimately, these changes will be of benefit to society and provide a competitive advantage to those who can move the fastest, especially when major retail chains become the dominant wholesale market. My advice is to start working on your HACCP-based compliance program immediately and, if you’re in Canada, seek a high-level certification like SQF as soon as possible.

It’s fair to say that the food industry’s recent experiences with more stringent regulations clearly foreshadow what will be required for the cannabis industry. Right now – when the margin of error is razor thin – is the time for companies to make the decisive move and focus on their success – and survival.

September 23, 2019

A Playbook for Growth: Start with a True Cloud ERP as Your Foundation

By David Stephans

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Cannabis businesses have become a driving force for economic growth in the United States. We’ve all heard the statistics. In 2018, the industry accounted for approximately $10.4 billion in revenue and is slated to grow to $21 billion by 2021.

But with growth comes pressure to produce more, enhance quality and optimize operations. However, managing a cannabis business without modern, capable tools can hinder growth and leave opportunities on the table. That’s why fast-growing cannabis businesses are looking to the proven benefits of a true cloud Enterprise Resource Planning (ERP) platform to help manage production, provide insights and improve business operations. When we add in the complexity and ever-changing nature of regulation, the need for a robust operational system becomes even more critical.

David Stephans will be speaking during CIJ’s October 9th webinar, “Driving Strategic Advantage for your Cannabusiness through Process Efficiency, Quality & Compliance” Click here to learn more and register for free.Cannabis business leaders may want to develop their own “playbook” to differentiate themselves in the market. But before they start to engineer their forward-thinking approach, they should start with a cloud ERP as their foundation. This can help with everything from the most basic of needs to more sophisticated strategies. In this article, we’ll review some key cannabis business goals and tactics, and how ERP can help lay the groundwork for success.

Drive growth and expansion.

Business growth often translates into operational expansion, meaning more facilities, staff and compliance requirements to manage. A cloud ERP supports these functions, including the launch of new products, expanding pricing schedules and increasing production to meet demand. Having the ability to track and manage growth is crucial, and a cloud ERP can provide the real-time reporting and dashboards for visibility across the entire business. This includes not just operational visibility, but also a look into a company’s sales, finances and supply chain.

Foster exemplary customer experience.

Cannabis companies need to streamline processes from the moment an order is placed to when it arrives at the customer’s door. In the mind of consumers, cannabis businesses compete against the likes of Amazon. They must be able to provide a similar experience and level of service, with customers receiving orders in a couple of business days. Cloud ERP can help automate processes. And when things go wrong, it can also help with resolution, especially when it’s paired with a customer relationship management (CRM) system on the same cloud platform. For the B2B market, cloud ERP empowers account management to review past orders to better meet future customer needs.

Stay a step ahead of the game.

In the industry, change is a constant. The future will likely bring about shifts in products, regulations and suppliers. A cloud ERP can modify workflows, controls and process approvals on the fly, so companies can adapt to new requirements. It offers security against emerging risks and easy integration with other systems cannabusinesses may need. An advanced cloud ERP will also provide cutting-edge capabilities, such as AI insights and data-capture from Internet-of-Things (IoT) devices.

Ensure quality product for raving fans and avoid flags on the field through airtight compliance.

Many cannabis companies are passionate about delivering the highest-quality cannabis products. Auditability is key to both quality and compliance. Complete traceability, with lot and serial number tracking, will record comprehensive audit trails from seed to sale. A cloud ERP will incorporate RFID tags down to the plant, lot and product levels to assist in this process. As cannabis goods move through their lifecycle, the cloud ERP will append appropriate tracking to purchasing receipts, inventory as it moves between locations, products as they’re packaged and sales orders as they’re fulfilled.

As a heavily regulated industry, cannabis business is also subject to burdensome compliance standards. A cloud ERP can support the rigorous testing that’s required to assure potency and safety. It easily facilitates Good Manufacturing Practices (GMP) and Good Production Practices (GPP), which ensures products are consistently produced according to quality standards. Many regulatory agencies require digital reporting; cloud ERP can facilitate this requirement through integration with Metrc, Health Canada and the FDA. Compliance can be a costly endeavor, and this type integration saves time, money, and effort.

As you can see, a cloud ERP helps efficiently balance compliance and regulatory requirements, with operational efficiency and customer service – key strategies in any cannabusiness playbook.