In Case You Missed It: GMP Basics

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Europe is the next big-ticket for medicinal cannabis, but it’ll take more than just having the right resources and team in place to make an entrance. The key to accessing this emerging market is having Good Manufacturing Practice (GMP) accreditation. A requirement that all medicinal products come from a GMP accredited manufacturer is one of many strict regulatory measures the European Union has put into place. Their aim is to assure both regulators and consumers that the products are safe, consistent, fit for purpose, and of the highest quality.

As part of our Vitalis educational series, our team of experts recently led a webinar on the process of obtaining a GMP certification for the equipment. In case you missed it, we’ve recapped the most important points to consider.

What is qualification versus validation?
Validation is an act, process, or instance to support or collaborate something on a sound authoritative basis. Qualification is an act or process to assure something complies with some condition, standard, or specific requirements.

Does the Factory Acceptance Test (FAT)  include actual extraction performance as performed on the customer like feedstock?
No. The FAT includes running the machine at a minimum and maximum operating parameters with no product. It allows for any issues with the machine to be identified in the absence of the product.

Are all of your gauges also field calibratable for future Performance Qualification?
Yes, all of the sensors and gauges can be calibrated by a qualified professional in the field.

Does re-using and recycling CO2 present any GMP challenges?
Re-using any solvent in a GMP environment does pose a challenge. You must prove that the recycled solvent will not affect the product quality of future batches.

Is there any statement in any of the GMP schemes that define Calibration requirements during the maintenance/life cycle of the equipment?
GMP regulations do not state how often instruments should be recalibrated as every instrument will be different. Manufacturers may provide a recalibration schedule, but it is ultimately up to the customer.

How does the development of Standard Operating Procedures (SOPs) fit into the GMP documentation sphere?
Any task that is done in a GMP environment that affects product quality should have a SOP to support that task. Having a SOP ensures that the task has been evaluated and is done the same way every time.

Does the scope of GMP change based on the stage of the process? For example, does a solvent tank require the same surface finish as an extractor?
They do not necessarily need to have the same surface finish. GMP is a risk-based system. If the risk of microbial or chemical contamination of the surface is high, then a smoother surface would be warranted to allow for easy cleaning. The solvent tank will probably only contain solvent and no product. Depending on the solvent, the surface finish may be rougher as the risk of microbial contamination is low.

Who is responsible for verifying and providing the GMP certification, and is it different per jurisdiction?
Every GMP jurisdiction will have a regulatory authority with inspectors to carry out audits.

Are EU-GMP regulations the most stringent?
It is hard to argue who has the most stringent GMP regulations, but the most highly regarded regulations can be found in the US (FDA), the EU, and Japan. Traditionally the FDA has been the largest pharmaceutical manufacturers while the EU and Japan are the largest markets, both bringing with them their own set of mature regulations.

What insight do you have into the qualification process for multiple pieces of equipment from different manufacturers?
Each piece of equipment in a GMP environment needs to be qualified separately, regardless if they are from the same manufacturer or not. When using multiple manufacturers, the qualification effort may be more as each manufacturer may offer differing levels of support and documentation. If you can procure equipment from the same manufacturer, then you only have to deal with one company, which may streamline your overall GMP validation efforts.

Is EU-GMP easier or more cost-effective for CO2 extraction technologies versus ethanol extraction?
Both can be used for GMP purposes. However, it all depends on the products you are manufacturing, as well as the pre- and post-processing methods required. There are additional infrastructure requirements when using ethanol and getting ethanol of the required grade may be difficult depending on geography.

Are cannabis extractors currently required to be GMP certified in Canada?
Cannabis extractors do not need to be GMP certified in Canada; they must adhere to Good Production Practices (GPP).

Is it possible to operate a GMP certified piece of equipment in a non-GMP certified facility? i.e. can you get a qualification on the machinery, but not the whole facility?
GMP certification applies to the entire production process, so you can’t have GMP certified equipment in a Non-GMP facility. You can have equipment that is GMP compliant and that receives the qualification in a non-GMP facility.

Is it possible to have a fully compliant lab and make dangerous products?
Many common pharmaceutical drugs and foods such as coffee, if consumed in excess, can be toxic and, therefore, dangerous. Most pharmaceutical drugs, if not taken as per the manufacturer's recommendations, can have harmful effects on an individual. Every pharmaceutical drug has to go through an approval process, and part of that is determining the safe dosage. If the advice is not followed, then there could be harm to the consumer, but if the advice is followed, there should be no issues, and the drug can be considered safe.

What if your terpenes are made in a Current Good Manufacturing Practice (cGMP) facility, but you add too much to a cartridge and vape at too high of a temperature?
Take, for example, if terpenes are made in a cGMP facility, but too much was added to the cartridge and vape at too high of a temperature. This has been occurring in the USA due to very lax regulation at the state level on vape cartridges and no regulation at the federal level. Equally, it means the FDA, the agency tasked with protecting consumer safety, cannot. The only way to avoid such a thing is for cannabis to be brought within the scope of the FDA where they can regulate the vape cartridge contents and set limits.

cGMP is one part of consumer safety, but does that mean it is necessarily assurance of its safety?
GMP is meant to protect consumer safety during the manufacturing process of the product. GMP has nothing to do with whether the product itself is safe. Product safety is covered when a pharmaceutical drug is submitted to the FDA for approval and is what clinical trials establish. GMP will guarantee that the product has been manufactured consistently and to the highest possible standards.

Interested in learning more about GMP? Speak to one of our experts today

GMP Documentation for the Cannabis Industry

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The legal medical cannabis industry is in full bloom across the globe. In North American markets, the dominant cannabis firms have firmly rooted their positions and are now setting their sights to Europe for new growth opportunities.

While medical cannabis is legal in a number of European countries already, it’s estimated that the EU's medical cannabis market could expand to over 123 billion euros within a decade.1

Gaining access to the EU’s medical cannabis market is no easy task – almost all medical cannabis that gets exported to Europe must come from a Good Manufacturing Practice accredited facility. Good Manufacturing Practice (GMP) is a best-in-class set of regulations that covers all facets of pharmaceutical drug production from raw materials, equipment, facilities, down to training and personal hygiene of staff.

GMP standards ensure pharmaceutical products are fit for purpose, high quality, consistently made, and safe for consumption. GMP regulations dictate that equipment must be made in a way that is streamlined, safe, and reliable.

GMP regulations are enforceable by law and once GMP accreditation is obtained, it must be maintained. Failure to do so can result in the loss of market access, fines, or class action lawsuits.

Gaining GMP accreditation has a double effect of providing access to new cannabis markets and improving your brand reputation. When consumers see a GMP-labelled cannabis package, they know the product is safe, clean, and will work as advertised. GMP certification also fosters trust with supply chain partners, which saves time and money when the time comes to make deals.

As an international GMP-compliant equipment supplier to the pharmaceutical and recreational cannabis industries, Vitalis specialists have a deep understanding of not only Canada's Good Production Practices (GPP) but GMP regulations around the world and will ensure that the qualification of the Vitalis equipment goes smoothly.

Since GMP rules are flexible and not a specific set of instructions, it’s the responsibility of every cannabis exporter to bring their production facilities into compliance with GMP rules. Due to the massive scope and highly technical nature of GMP, it’s vital to get the help of an experienced consultant early in the compliance process.

Bringing in a GMP Consultant:

A GMP consultant looks at your facility, equipment, processes, documentation, and even your supply chain to determine what is required to bring your facility into compliance, and how to focus your company resources on the highest impact areas.

Through the Validation process, you’ll create in-depth documentation proving that you’re in compliance with GMP rules every step of the way, so that your facility passes inspection the first time. While qualifying equipment is ultimately the customer’s responsibility, a GMP consultant will help you through the process.

What Documentation is needed for GMP Qualification of equipment?

A typical equipment qualification process will begin with the User Requirements Specification (URS), which outlines a customer’s regulatory, materials, construction, and safety needs. At Vitalis, we aim to reduce the validation burden on the customer by providing standardized URS documents that reflect our standard machine offerings as a starting point. Customers then review this document and work with Vitalis to tailor the requirements of the equipment to suit their processes.

Following the URS is the Design Qualification (DQ), which translates the requirements in the URS into the equipment design. For efficient auditing purposes, it’s critical to have traceability between the URS and the DQ. The results of the Design Qualification allow a customer to assess the suitability of the equipment for their facility.

Upon completion of the build and before shipping to the customer, a Factory Acceptance Test (FAT) is performed. During Factory Acceptance Testing, the equipment is tested under the minimum and maximum operating conditions to ensure that it performs as expected. Measuring devices such as gauges and sensors are tested for accuracy, and safety features such as e-stops are checked to ensure they are operating as designed. The FAT is reviewed by the Vitalis Quality Team and supplied to the customer as part of the turnover package.

Before a piece of equipment can be used in production, it undergoes an Installation Qualification and Operational Qualification (IQ / OQ).

Installation Qualification is a process that includes checks to ensure equipment has been correctly installed. As well, it verifies that utility connections have been made properly, that the equipment has been placed in an acceptable location, and that it adheres to the manufacturer's design and install requirements.

Operational Qualification is the process of running the equipment at its maximum and minimum operating parameters to ensure the equipment performs safely and consistently at all operating ranges and provides verification that the system is ready for product runs.

Vitalis not only provides an IQ/OQ protocol as standard with every GMP machine, but our expert Service Technicians will also visit our customers to execute the IQ/OQ protocol.

The last qualification step is the Performance Qualification (PQ). The PQ is the documented verification that systems and equipment perform effectively under prescribed production conditions. That is, it qualifies the customer’s approved process methods and product specifications. While the customer is ultimately responsible for this qualification step, Vitalis can offer support when needed.

The Turnover Package (TOP) is the final set of documents in the qualification effort that provides the documented evidence that the equipment was designed, constructed, and tested in accordance with the customer's requirements. The Turnover Package includes material traceability records, certificates of compliance, engineering drawings, critical user information needed to maintain the system like maintenance intervals and procedures, and spare parts lists. It is also critically important that the documentation provided in the Turnover Package adheres to Good Documentation Practice, which outlines how documentation should be prepared, filled out and corrected.

Vitalis assembles a comprehensive Turnover Package for every GMP system built. As experts on the design and construction of the machines, it makes sense to ensure that all documentation is accurate and ready for delivery. Taking this step helps to reassure customers that their Vitalis equipment can be qualified for compliance within their GMP environment. It's just another way that Vitalis continues to lead the industry in GMP and customer support.

Talk to Vitalis about setting up a GMP-compliant extraction system.

1. Will Europe be the world’s largest cannabis market? https://www.healtheuropa.eu/medical-cannabis-market/90033/

GMP Overview Part 3: How To Get Ready For GMP

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Deciding to become GMP certified is a crucial first step, but before embarking on the journey it is imperative that a cannabis supplier or manufacturer is both prepared and understands what is required for GMP certification. Failure to plan properly and allocate the necessary resources can have a significant detrimental impact upon a business. Getting the GMP certification process right will save time, money, and resources, and can be highly advantageous for a company involved in the cannabis industry. Not only does it allow greater market access, but it also helps to reinforce the quality and reliability of the product being sold. Here are some important steps and considerations that companies should take into account as they get ready for GMP certification.

Getting a GMP specialist

When first considering whether to gain GMP certification, it is important to have an experienced specialist to assist you. This GMP specialist can be an internal or external resource and is essential to navigate the intricacies of GMP legislation and compliance. This person should have the skills to be able to conduct a gap analysis and report their findings. This process will identify the gaps between current processes and GMP requirements and provide recommendations to get the business ready for certification. It is far more efficient and effective to identify gaps early as implementing GMP retrospectively can incur significant costs. Knowing the cost and effort required to obtain GMP certification upfront allows for effective planning and minimizes the overall cost.

Risk Assessment

GMP covers all aspects of production from the raw materials, facilities and equipment, to the training and personal hygiene of staff. GMP requires that a business carry out a risk assessment of all their processes, identify areas that contain potential risks, and adopt strategies to minimize their occurrence. High risk areas identified from the gap analysis will require a larger qualification and validation effort than areas deemed to be lower risk. Typically identified high risk processes include manufacturing equipment, facilities, and personnel that work directly or closely with product. The areas of risk will differ between different manufacturers and suppliers, so it is important to understand all processes and the risks each pose.

Becoming GMP Certified

Gaining GMP certification requires a cannabis supplier or manufacturer to complete a GMP audit process. The auditors will be representatives from the regulatory authority for which the business wishes to gain certification, and the auditor’s agency will differ between jurisdictions. For example, the Food and Drug Administration (FDA) GMP inspection will be conducted by an auditor from the FDA. In the EU, while the European Medicines Agency (EMA) will coordinate inspections, the inspection itself will be carried out by a national authority in one of the EU member states. Here in Canada, to gain EU GMP certification an auditor from an EU member state will complete the audit.
Following the inspection, an audit report is produced stating whether or not certification has been achieved and provides corrective actions to be taken where it has not.

Every effort is made to ensure auditors are consistent in their interpretation of regulations. Even so, the individual auditors’ readings and inferences are subjective – what one auditor might find acceptable another may not. It is important to note that such discrepancies are uncommon and where they occur, processes have been established for resolving any potential audit disputes.

Maintaining GMP Certification

Maintaining GMP certification is important in ensuring continued market access and product accreditation. This can be achieved through measures such as properly maintaining equipment and facilities, following standard operating procedures, and ensuring GMP documentation is in order and available to inspectors. GMP auditors can conduct both scheduled and surprise inspections to ensure manufacturers or suppliers remain compliant. Failure to comply with GMP regulations can result in severe penalties such as shutdown of manufacturing facilities, seizure or recall of product, and even criminal investigations and lawsuits, all depending on the level of non-compliance. While it is possible to re-gain GMP certification or to fix any non-compliance issues, depending on the financial implications of the penalties imposed, for smaller businesses it could lead to failure of the business.

As more businesses within the cannabis industry look to implement GMP, manufactures or suppliers that follow suit will not only increase their business opportunities, but will also develop a reputation of excellence in the quality of products they produce. The need for GMP certification will soon increase as it appears GMP will become the standard for medical cannabis products and potentially for recreational products as well. Understanding what is involved in the GMP process is essential for a company looking to become involved in this space.

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When Outfitting Your Lab, Choose CO2. Here’s Why:

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THE DIFFERENCES IN CANNABIS EXTRACTION TECHNOLOGIES

The cannabis industry today is comprised of three main extraction technologies; carbon dioxide (CO2), ethanol and hydrocarbons. Although these extraction methods are different, they all try to achieve the same objective of extracting valuable compounds from cannabis plant material. The main compounds targeted by these extraction systems are cannabinoids and terpenes, but each extraction method has its own respective advantages and disadvantages when extracting these compounds. Not only are the differences solely in how the compounds are extracted, but also extend to extraction safety, environmental impacts and costs. Having an understanding of these extraction methods is important when determining what cannabis extraction method to use. The characteristics that would be important for someone looking to purchase cannabis extraction equipment are discussed below for the three extraction methods mentioned.

CO2

CO2 in its liquid form can be used as an extraction solvent if its temperature and pressure are within the liquid phase range, or as a supercritical fluid if its temperature and pressure are above both 87.98 F and 1071 psi. It is an outstanding solvent for volatile compounds such as terpenes and, as a supercritical fluid, is good for cannabinoid extraction. The final separation of the solvent from the extract is achieved by a density drop that allows CO2 to evaporate from liquid or supercritical fluid to gas. The liquid cannabis oil that is left behind is free of any residual solvents.

Table 1: CO2 extraction system characteristics

Criteria CO2
Scalability Low to high
Infrastructure Required No significant infrastructure required
System Cost Medium to high
Product Options High; tuneability and terpene preservation allows for diverse product offering
Extraction Run Times Medium - long
Energy Usage Low to medium
Solvent Cost Very low
Tuneability Yes
Terpene Preservation Yes
Post Processing Winterization may or may not be required, depending on feedstock input and desired product formulation
Residual solvent in crude extract No residual solvent in extract
Pre-cool solvent No
Feedstock waste No residual solvent, general waste
Solvent Generally Recognized as Safe (GRAS) Yes
Safety High pressure
Solvent disposal Vent to atmosphere

The tuneability of CO2 and its ability to switch between a liquid and a supercritical fluid is a tremendous advantage for this process, and allows for a more diverse range of product offerings. Depending on the chosen parameters, extraction of undesirable compounds such as chlorophyll and lipids can be reduced, or a terpene pull can be completed using a subcritical run. As CO2 can extract at lower temperatures and pressures, subcritical parameters are good for targeting low molecular weight terpenes while leaving other components behind. Typically, with CO2 extraction, a post-processing step of winterization is required to remove undesirable compounds.

Another major advantage of using a CO2 extraction system is the relatively small infrastructure requirements. Unlike ethanol or hydrocarbon extractions that require a Class 1 Division 1 or 2 space, no specialized infrastructure is needed. This represents significant cost savings up front and helps mitigate the expense of the equipment.

CO2 extraction is the leader in safety in terms of residual solvent toxicity as well as environmental impacts relating to solvent disposal. Most extractors will reuse the CO2 or simply vent it to the atmosphere, saving on costly hazardous waste solvent disposal. CO2 is relatively inexpensive to restock, so even when levels need to be topped up, the costs are minimal. This is yet another area in which CO2 proves its affordability in the long run. With the savings on infrastructure, and the long-term costs of maintaining solvent stock, CO2 ends up being a more cost-effective process than the alternatives.

Ethanol

Ethanol extraction is best performed at temperatures below -40 °C, where the co-extraction of undesirables is minimized. However, cooling ethanol to these temperatures can require significant amounts of energy and time. Ethanol is a polar molecular, and this can create issues as it will readily mix with water and dissolve water soluble molecules such as chlorophyll. However, at temperatures below 40 °C this phenomenon is limited. During the extraction process, ethanol is passed over the cannabis material to dissolve the active compounds in the plant.

Table 2: Ethanol extraction systems characteristics

Criteria Ethanol
Scalability Low to medium
Infrastructure Required C1D2 or C1D1 space
System Cost Low to medium
Product Options Low to medium; poor terpene solubility means smaller product offering
Extraction Run Times Short to long, depending on solvent cooling duration
Energy Usage Low to high, depending on solvent cooling
Solvent Cost Medium to high
Tuneability No
Terpene Preservation No
Post Processing Winterization may or may not be required, depending on solvent cooling
Residual solvent in crude extract Solvent recovery required
Pre-cool solvent Below -40°C to minimize co-extraction of undesirables
Feedstock waste Residual solvent, hazardous waste
Solvent Generally Recognized as Safe (GRAS) Yes
Safety Flammable
Solvent disposal Hazardous waste

A major advantage of ethanol extraction systems is that they have a low cost of entry. However, due to ethanol’s flammability, infrastructure to support such an extraction system is more costly due to the requirements for hazardous locations (C1D1 or C1D2 – which means there is an ignitable concentration of flammable gas or vapour that has to be contained).

Terpenes have low solubility in ethanol which results in an oil that can lack flavour and aroma, and a reduced product offering for the extract. What ethanol excels at is cannabinoid extraction and it tends to have shorter extraction run times which is highly beneficial for throughput. The tuneability of the ethanol extraction method is very low and is primarily used to target cannabinoids. Ethanol, like CO2, is also generally recognized as safe (GRAS) for consumption by the FDA. But an important consideration is solvent recovery as residual solvent in the product could harm end users. Furthermore, ethanol waste is classified as hazardous, which in turn requires special handling and disposal.

Butane

Hydrocarbon extraction equipment typically uses butane, propane, or hexane as the extraction solvent (although most commonly butane). Cold butane is washed over the cannabis material, which slowly dissolves the cannabinoids and terpenes. As it is non-polar, it binds to the more fat-soluble components of the plant (cannabinoids, terpenes and lipids) and less so to chlorophyll and other plant metabolites. As it has a low boiling point (-0.5°C/31.3°F), very few temperature sensitive terpenes are lost when boiling off the residual solvent from the concentrate solution.

Table 3: Hydrocarbon extraction systems characteristics

Criteria Hydrocarbon
Scalability Low to medium
Infrastructure Required C1D1 space
System Cost Low to medium
Product Options Medium to high; terpene preservation and cold processing allows for diverse product offering
Extraction Run Times Medium
Energy Usage Low
Solvent Cost Low to medium
Tuneability No
Terpene Preservation Yes
Post Processing Winterization may or may not be required and desired product
Residual solvent in crude extract Solvent recovery required
Pre-cool solvent No
Feedstock waste Residual solvent, hazardous waste
Solvent Generally Recognized as Safe (GRAS) Yes (for butane)
Safety Pressurized and explosive
Solvent disposal Hazardous waste

Butane extraction is excellent for the extraction of cannabinoids and terpenes under the same conditions, and when done properly can produce a terpene-rich end product that closely resembles the starting plant material. This process tends to produce great tasting concentrates like shadder, budder, sauce and more.

However, butane and other hydrocarbons are highly flammable and volatile, which means there are strict regulations that surround butane extraction systems. Again, like ethanol extraction, a hazardous location space is required, and a solvent recovery step is needed following extraction. The spent butane is also classed as hazardous waste and appropriate environmental disposal is required.

While ethanol and butane extraction systems have their place in cannabis extraction, CO2 has proven itself to be one of the most adaptive and safe cannabis extraction methods. The CO2 extraction process is well known for its low up-front infrastructure cost, safe solvent use, scalability, and tunability. These factors, along with its long-term environmental sustainability, make CO2 an excellent choice for cannabis extraction.

Buying Tips: Not All Machines Are Created Equal

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SAVE TIME, EFFORT AND STRESS WITH THESE CONSIDERATIONS

When looking at extraction equipment, there are a lot of things to keep in mind. Price, reliability, safety and performance are top criteria that come readily to mind. For any business owner, procurement manager or buyer, the key goal is to ensure that they get a good deal on a system that will meet the company needs. To ensure a positive experience, and an efficient decision-making process, Careful consideration of the following factors will help keep your extraction system evaluation(s) on track for a successful purchase..

KNOW YOUR END GOAL

When you're looking for CO2 extraction equipment, the first thought should be to your end goals. What do you want to produce? Different market products call for different pathways to production, including with regards to equipment requirements. For example, will you need to perform extractions in both subcritical and supercritical states in order to extract the target compounds for your products? Will you need to pull every ounce of recoverable material out of the biomass or will your profit curve require you to end an extraction run early? Will your system need to have precise control over the extraction parameters or are you comfortable spending more time on post-processing? Understanding the end product you want to produce will allow you to trace back through the process, identify the appropriate extraction equipment, and make informed decisions based on profit margins, resource requirements, and time.

BE CLEAR ON CAPACITY NEEDS

If your extraction plans require you to process thousands of pounds of biomass a week, you'll need to look at systems that have the capacity to meet those requirements. Small-volume systems, or systems requiring longer run times can make it hard to reach large volume goals. Understanding the volume of feedstock you'll be working with is a huge factor in making a smart decision on extraction equipment. It can also help you identify other revenue opportunities. For example, if your volume needs are small, perhaps it makes business sense to do toll-processing, making a profit by processing another supplier’s biomass.

AVOID OUTRAGEOUS CLAIMS

A savvy shopper knows the importance of investing time in understanding a process or product before making a purchase. Marketing strategies in the extraction environment are often flooded with outrageous claims. It is important to understand the science underlying the process of extraction and that, regardless of equipment type or manufacturer, no piece of machinery can operate outside of physical laws. Time spent studying the fundamental principles of how temperature, pressure, time and flowrate factor into extraction will pay dividends in vetting sensational schemes and decoding fine print.

YIELDS VS RECOVERY VS EFFICIENCY

Yields is an entire topic on its own and comes up quite frequently in conversation about extraction equipment. Most often, it is used as a simple measure for buyers to evaluate the efficiency of a system. However, using yields as a measure of extraction efficiency is akin to using horsepower to evaluate the speed of a vehicle - a semi-truck can have excessive horsepower, but that doesn't necessarily mean it will go fast. Bulk yield is a measure of the total mass of material that results from an extraction, but it doesn't provide a clear picture of the amount of valuable material recovered. Understanding recovery percentage and knowing the chemical composition of the biomass can help eliminate confusion on the topic of yields and prevent decision-making based on erroneous criteria (for a better understanding of Yields, read this article).

LICENSING & FACILITY

Licensing and regulations can vary dramatically between nation, state, city and even county lines . The products that can be processed, the size and engineering requirements of the facilities, and the type and amount of chemicals allowed on-site are all major factors to consider before going too far on your extraction system purchase. But more than just the regulatory landscape, the simplest reason to consider your facility and lab setup before buying equipment is to ensure that you'll be able to get it into the room. It's rather difficult (impossible) to move a five-foot-wide piece of equipment down a four-foot-wide hallway, and putting a ten-foot-tall system in an eight-foot-tall room can be a daunting (also impossible) task. Knowing your building dimensions and size requirements can save from excessive retrofitting costs down the line.

SCALING & COSTS

Having clarity on desired growth, sustainability, and a solid plan in place are also key factors to consider when choosing extraction equipment. While these are certainly true of any business venture, they should be included within this decision-making process. If your goal is to scale and grow, purchasing equipment that can do the same is a smart idea. By the same token, obtaining a system that will require multiple installations in order to scale can be costly and negatively impact your overall efficiency.

As well as examining your growth potential, understanding the difference between capital expenditures (CapEx) and operating expenditures (OpEx) is important when looking at long term strategies. In some cases, higher CapEx can lead to much lower OpEx in the long run, creating a positive ROI in a shorter amount of time. Without thoroughly examining the options, it can be easy to go with a lower upfront cost despite the fact that it can be detrimental to growth in the long run. Being clear on your finances and estimated return from the start, you can save yourself from stress and unnecessary expenditures in the future.

Often in the buying process, it's easy t get blinded by low-cost options and empty promises. Negotiations over cost and delivery have become a natural part of the process. Of course, there are many more factors to consider when making a significant purchase, as is the case when evaluating CO2 extraction equipment. By keeping the above tips in mind, you will be better prepared to make a sensible decision that can set the stage for your company's future success.

If you're looking at making an investment in CO2 extraction equipment and are unsure where to start, these tips are a great spot. For further help and assistance, reach out to our Business Development team to get the conversation started. They'll help identify an equipment solution to perfectly fit your short-term and long-term goals.

GMP Overview Part 2: To GMP or not to GMP

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To GMP or not to GMP

Within the cannabis industry, there are some clear advantages to being GMP (Good Manufacturing Practice) certified. Further, having a good understanding of these GMP regulations is highly beneficial when it comes to bringing cannabis products to market. Whether a company embraces GMP or not will be determined by many factors, including the products the business wishes to produce, what jurisdictions those products will be sold in, and cost. To better understand the implications of GMP certification one must carefully assess the advantages and disadvantages.

Although GMP can be a complex and time-consuming process, some distinct advantages that GMP certification can offer are;

  1. Increased product credibility and consumer assurance that a product has been manufactured to the highest quality standards;
  2. A competitive advantage in the marketplace over non-GMP certified products;
  3. Decreased time and cost barriers for companies searching for certified contract processors;
  4. Reduced costs and increased efficiencies associated with rework and penalties due to non-compliance;
  5. Increased confidence of a manufacturer’s management team in the preparedness of manufacturing facilities for inspection and confirmation of the maturity of their quality program.

Even with the benefits GMP certification can bring to a business, it is imperative to understand certification and compliance requires significant investments of time, money, and personnel. These factors can be substantial hurdles in obtaining certification, particularly for smaller businesses.

GMP & Jurisdictional Authority

Notwithstanding the advantages listed, whether a company decides to pursue GMP certification comes down to the market in which they want to sell their products. If a medical cannabis supplier or manufacturer has decided to become GMP certified, then they must meet GMP regulations for the jurisdiction(s) in which they wish to sell their product.

For example, an American pharmaceutical manufacturer wanting to sell their products in the USA and the EU must be GMP certified in both those jurisdictions. Although authorities in different regions – including Canada, the USA, and the EU – have historically developed and enforced their own GMP regulations, there has been momentum in the last few decades to harmonise these guidelines. This typically happens through Mutual Recognition Agreements (MRA) and the establishment of organizations like the International Conference on Harmonisation (ICH).

An MRA, as it relates to GMP, is an international agreement aiming to deliver greater market access and coordination of regulations while maintaining consumer safety. These agreements allow authorities in two different jurisdictions to rely on one another’s GMP inspections, share audit information and quality defects, and reduce or eliminate the testing of products upon import into their regions of authority.

The Markets and EU GMP

The EU is unique with its current regulatory framework for cannabis. Currently, no member states permit legal recreational markets, though a handful have passed legislation to allow access to medicinal products. Jurisdictions that have introduced some form of medical cannabis regimes – including Germany, Denmark, and Malta – have called for all products to be cultivated and processed in accordance with EU GMP standards. As these guidelines have already been established for pharmaceutical products, most countries pursuing medical cannabis laws are also accepting them. More demanding than any other cannabis manufacturing regulations in the world, the EU has set the tone for where the market is heading in the future.

Despite the European Parliament passing a resolution in February 2019 calling on the European Commission (EC) to harmonize cannabis regulations across the EU, there is no central regulation or guidance on cannabis products in the region. This means that businesses wishing to sell or produce cannabis products in the EU must do so in a member state that permits such activities. However, based on the number of EU member states that have already implemented medical cannabis programs, it is likely the EC will provide region-wide direction on medical cannabis in the near future.

Since the EU has such huge market potential, with some estimates suggesting that by 2028 the medical cannabis market could be worth CAD$185 billion, cannabis cultivators and processors around the world are moving towards EU GMP certification in order to gain access. The EU has MRAs with many other countries in the world including Canada, Australia, New Zealand and Japan. If cannabis cultivators and processors gain EU GMP certification then they can potentially leverage the MRAs to gain access to these other markets. It is very important to note that medical cannabis is not currently included in the scope of these MRAs, but this may change in the future as more countries adopt medical cannabis programs and look to import and export these cannabis products. Furthermore, the USA has yet to fully harmonize or share in these MRAs with the EU for drug products.

The implementation of GMP is becoming crucial within the cannabis industry to align international market participants to known standards and regulations for medical products, all for the safety of the end consumer. This will allow much greater market access for any business involved in medical cannabis, from suppliers to manufacturers. Still, it is important to note that as GMP certification covers all aspects of production – from starting materials and premises, to the equipment being used and the training and hygiene of staff employed there – it is beyond the scope of many smaller businesses. However, it does appear that GMP certification will become the norm for medical cannabis products, and (as mentioned in Part 1) lack of compliance could become a reason for restricted access to some markets and/or loss of sales. The last part of this series on GMP will cover how to get ready for GMP certification and go into further detail on how to achieve certification and what it covers.

For a full introduction to GMP, feel free to view our recent GMP Webinar: Part 1 presentation here. And if you haven't already, sign up for our monthly newsletter to stay in touch and up to date with all of our ongoing extraction education.

GMP Overview Part 1: What is GMP?

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In an effort to ensure medical cannabis products are safe for consumers, many countries around the world are adopting Good Manufacturing Practice (GMP). GMP certification ensures creation of safe and effective medical cannabis products that are held to the highest manufacturing standards, much like traditional pharmaceutical products. As countries move to regulate medical cannabis products under the GMP umbrella, cannabis producers, manufacturers, and suppliers are having to understand and implement GMP in their businesses.

This article is the first part of a three-part series looking at what GMP is and its importance, the costs and benefits of GMP compliance, and the areas of the GMP process an equipment vendor can play a central role in.

With GMP becoming more significant in the cannabis industry, what is GMP?

GMP is a series of regulations that are enforceable by law, used to ensure products are consistently created in such a way as to meet rigorous quality standards. Typically, the agencies responsible for issuing GMP regulations are also responsible for enforcement. These regulations provide minimum requirements that a manufacturer must observe to ensure all products are safe, fit for the intended purpose, of high quality, and of consistent formulation or construction.

The regulations cover product categories including pharmaceuticals, food and beverages, dietary supplements and medical devices. GMP also covers all aspects of production from the raw materials, facilities, and equipment to the training and even personal hygiene of staff. This reinforces the primary goal of GMP: to prevent harm to end users of a product.

GMP regulations are not rigid instructions on how to manufacture products and structure processes. Such strict regulations would not only be impractical to translate across numerous industries, but it would also remove the motivation for manufacturers to innovate and adopt new technologies and methodologies. Instead, the requirements were established to be flexible, allowing manufacturers to determine the best way to implement scientifically sound design, processing systems, and testing procedures.

This flexibility allows adoption of the most up-to-date technology and methods, as well as letting companies decide the best way to implement the controls necessary to achieve the highest quality within their organizations. When manufacturing processes and quality systems are set up by a manufacturer, there may be many ways in which they can fulfill GMP requirements. The responsibility is on the manufacturer to determine the most effective and efficient quality process that meets both business and regulatory needs.

Is GMP always the same everywhere?

GMP guidelines and interpretations differ between both countries and regions, and even over time. Due to this consistent change, the most recent iterations are often referred to as Current Good Manufacturing Practice (cGMP). This system ensures that manufacturers use the most current systems and technology, as cutting-edge practices of 20 years ago may no longer be acceptable by current standards.

Why is GMP important?

First and foremost, GMP is for consumer safety. A consumer of medical cannabis products needs to trust the efficacy and quality of the products they are prescribed. Having checks and balances through GMP regulations gives manufacturers the ability to pick up on quality defects early and ensure unsafe products are not released to the public. There have been many documented cases where quality processes were not followed, and defective products were released. This highlights the importance of GMP regulations and the critical role they play in consumer safety.

For the businesses involved directly with medical cannabis, there are some distinct advantages of adopting GMP. Many authorities around the world, including the USA, Canada, Australia, Japan and the European Union (EU), require the application of GMP in the production of drugs, food, and cosmetics that will be sold in their respective markets. GMP certification will allow access to more markets. While GMP is not enforced in every country where cannabis cultivation is legal, it appears that GMP will become the norm for medical cannabis products and potentially for recreational products in the future. Thus, although GMP enforcement may not be required, lack of compliance could become a reason for restricted access to some markets and/or loss of sales.

Want to know more?

Register today for our GMP Webinar

June 18, 2019 11AM Pacific / 2PM Eastern

ICBC Berlin Cannabis Extracts Panel

ICBC Berlin Cannabis Extracts Panel featuring Vitalis Co-Founder and COO, Pete Patterson

Vitalis Extraction Technology COO and Co-Founder, Pete Patterson was among a group of panelists speaking at the International Cannabis Business Conference (ICBC) Cannabis Extracts panel in Berlin last month.

Along with panelists Mike Palumbo of Lab Society, Dave LaRussa of Apeks Supercritical, Zach Peyser of Sho Product’s, and moderator and freelance journalist, Michael Knodt, they discussed present extraction products and technology and where the industry is headed in terms of industry standardization and compliance.

In a young, burgeoning market, there are a number of concerns involving standardization of products, and the regulations surrounding them. Expertise from North American companies can be invaluable in Europe, as the region starts to tackle industry questions of legislation, medicinal vs recreational and distribution.

As much of the knowledge base in Europe tends to be held privately, events like ICBC help promote discussion and idea sharing to a wider audience. As a global leader in the extraction space, Vitalis was proud to send Pete to speak on this panel, further demonstrating the company's commitment to knowledge sharing and thought leadership.

For more information on the International Cannabis Business Conference, locations and event dates, visit: https://internationalcbc.com/

Press Release – October 2, 2018

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Canada’s First ASME Certified Extraction Equipment Manufacturer

Vitalis Extraction Technology Raises Bar, Sets New Standard in Growing Cannabis Industry

KELOWNA, BRITISH COLUMBIA,CANADA , October 2, 2018
Vitalis Extraction Technology, the largest supercritical CO2 extraction equipment manufacturer serving the international cannabis industry, today claimed the title as Canada’s first and only American Society of Mechanical Engineers (ASME) BPV certified extraction original equipment manufacturer (OEM) in the cannabis industry. The announcement comes on the heels of the company’s rapid expansion that doubled its production capacity.

While all Vitalis Extraction Technology equipment has always been designed, fabricated, and tested and certified in accordance with the latest ASME and CSA codes, the recent ASME certification now allows Vitalis to manufacture its own certified pressure vessels in-house, owning the process from start to finish.

“Becoming ASME certified to manufacture fully-certified vessels in house was a huge undertaking and an even bigger accomplishment,” said Pete Patterson, COO and co-founder of Vitalis Extraction Technology. “ASME completed an extensive audit of our fabrication facility and processes and found our methods and procedures to be excellent. Being able to produce certified vessels in house is unprecedented in our nation’s industry. Reaching this goal was a true team effort that involved everyone from our founders to engineers and fabricators who all knew what it would take to keep us ahead in this competitive and growing market.”

Founded in 2016, Vitalis Extraction Technology produces the most sophisticated high-flowing, industrial-scale, supercritical CO2 extraction systems for the cannabis industry. Renowned for their reliability, scalability, and continuous operation, all Vitalis systems are designed and manufactured in accordance with ASME and CSA Standards for Boiler, Pressure Vessel and Pressure Piping Construction. Each vessel is stamped with a CRN and NB registration number confirming that the vessels meet both US and Canadian code requirements.

“Simply being ‘designed-to-code’ isn’t enough when you’re handling a high-pressure system,” said Joel Sherlock, chairman and co-founder of Vitalis Extraction Technology. “Extraction systems are a required component in cannabis oil production. With something so imperative yet potentially dangerous, safety is critical. Owning this process allows us to continue to build certified, ‘future-proof’ machines, designed to expand for increased output and volume as a customer’s demands increase.”

With full legalization on the horizon, tightened regulations are inevitable. Vitalis' ASME certificate affirms that each system is built in accordance with the latest regulatory codes, eliminating downstream problems for customers by helping to ensure compliance with their local jurisdictional requirements for installation and operation. Voted Top Extraction Equipment at the 2017 Lift Canadian Cannabis Awards, Vitalis is on the forefront of emerging Canadian and global markets. On track for a 105% increase in sales this fiscal year, these accomplishments confirm Vitalis’ place as the largest commercial supercritical CO2 extraction equipment company in the cannabis space in North America.

PRESS CONTACT

For Additional Information, please contact

Judy Campbell, Campbell Consulting
judy@campbellconsulting.com, 541-410-9113