Last month an article in the Motley Fool highlighted the newly acquired EU GMP certification for Aurora Cannabis. With exportation of cannabis to European Union becoming increasingly popular, more LP’s are seeking to acquire this ceritification to expand beyond the Canadian market.
Orion GMP Solutions is one of the leading GMP compliance firms helping the cannabis industry go international. If your company is interested in EU GMP compliance or becoming one of the first companies in the US to be GMP compliant contact us at info@oriongmp.com. We offer free consultations to help you work towards international compliance or to simply adhere to your state and local guidelines. GMP compliance is complex and Orion GMP Solutions is here to help you every step of the way.
Consumers often assume the product they are buying is, for all intents and purposes, what is labeled or described on the packaging. They make the purchase without second thought on what is being purchased. It is usually a fair assumption, and due to the innocuous nature of most products, the buyer is not out anything more than The time and frustration of sending the product back to the purchasing location. Consumer goods generally come with a guarantee to ensure that the consumer can will be satisfied with the product, or the manufacturer with replace or refund the product at their own expense. That is all well and good for the consumer, but what about business to business transaction where the buyer is another business?
In these cases the buyer would be out more than just time and frustration as the product purchased could cause a loss of income if the product is an ingredient for the buyer’s product line. For example, a nutrient supplier mixing up product lines and cannabis cultivator applying a feeding cycle of micro nutrients while assuming low concentration and subsequently burning up the entire crop. In this case there would be lost revenue due to loss of plants and lost time spent to this stage of growth, All of which must be restarted – both time and money lost.
In the worst case, a consumer of cannabis products like vape cartridges or tinctures is harmed from unsterilized containers due to poor handling practices or sterilization techniques. This would cause patients or consumers to shy away from the manufacturer all together. In these cases, the brand is harmed and those losses are hard to quantify. However, irreparable damage can be assured. So how do businesses protect themselves when buying from another manufacturer? How do these companies ensure that what they are buying is what they are getting? After all, the livelihood of their products and overall brand of their company is at stake.
Supplier Quality Agreements and vendor audits make these assurances so that business to business transaction are protected by more than just a replacement or refund. A supplier quality agreement is a contract between a supplier and a buyer for specific products that are being purchased. This contract details all aspects of the purchase, such as packaging quantities and labeling of the product and its contents, to the specifications that each shipment or lot of product must meet for the product to be accepted by the buyer. The agreement spells out the testing requirements and reporting of data that the buyer receives each time a purchase is made for a quantity of product. This ensures that each order must meet the specifications set by the buyer, and not the assumed quality of the manufacturer.
What sets these agreements apart from the normal consumer “guarantee” is the fact that these contracts can hold the manufacturer liable for defective product that is purchased and lost revenue due to the poor quality of the product. Supplier quality agreements protect the company’s best interests and transfer a part of the risk from the buyer to the supplier. It is worth noting that having a means of verifying the testing results is a best practice. This is a sure fire way to eliminate all doubts about the contents of the product.
At the end of the day, supplier quality agreements will allow the cannabis industry to concentrate on what they do best. The company is protected from losses in revenue and time spend while the consumer focus of health and safety is maintained. Let the trusted quality professionals at Orion help you navigate the complexities of supplier quality agreements so that you can spend less time worrying about your supplier and more time on your final products. Contact us today at Orion GMP Solutions or by email at info@oriongmp.com to get started on your supplier agreements.
Starting August 30, 2017, every batch of usable marijuana must be tested directly for pesticides according to the Oregon Health Authority’s testing rules in order to be compliant. This includes product that was sampled prior to August 30.
The state of Oregon is continuing to lead in terms of standardizing quality in the cannabis industry. As of August 30th, cannabis cultivators and producers test and qualify 100% of batches going to dispensaries from an ORELAP (Oregon Laboratory Accreditation Program) accredited testing laboratory. These labs undergo a biennial review from the state to ensure that the laboratory has procedures in place that adhere to internationally recognized standards.
Raw flower and concentrates including edibles must pass testing for pesticides, water activity and moisture content, potency of cannabinoid compounds, and microbiological contamination. Oregon Health Authority has created an overview of the testing and reporting requirements.
Before the mandate was in place, only 30% of batches required testing before approval to be sold in local dispensaries. In a bulletin published this week, cannabis organizations will be required to test all harvest and production batches of cannabis before going to market.
Initially, the reduced testing requirements were the consequence of a limited number of accredited testing laboratories. Currently, for a lab to be certified to test cannabis or its products it needed to be accredited by the ORELAB and licensed by the OLCC. The number of labs has increased from 5 to 10 since the initial requirements.
Since last year, there have been 3 instances of recalls in the state of Oregon. Two recalls were initiated by the Oregon Health Authority and 1 by the Oregon Liquor Control Commission. In our article, The Downfall of a Recall, we identified how all of these instances could be avoided with the proper quality systems in place.
The increase in inspections definitely has the patients and consumers best interests at heart but these inspections are simply filtering out the defective products. Quality can never be inspected into a product, rather it must be inherently incorporating into the production process. Oregon and the rest of the country must continue to push for standardization of the industry and regulation for the manufacture of cannabis and cannabis products.
To learn more about quality by design and creating processes that bring inherent quality to your products contact us at info@oriongmp.com or visit our website for more information.
In 1996 California introduced cannabis for medicinal use, opening the doorway to legalization in the United States. Many other countries and cultures have recognized cannabis for its therapeutic properties. and Now, more than a decade into the twenty-first century, has the US began to accept this notion as well.
Cannabis is now the fastest growing industry in the United States with sales slated for $7 billion, more than a 25% increase from 2016. A poll by Gallup shows that cannabis approval is up to 60% of the American public in 2016 which is 50% higher than 2011. In 2012 Colorado and Washington State became the first states to have recreationally legal cannabis for consumption by those 21 years of age or older.
By 2017 states across the union have recognized cannabis for medicinal use. Currently, 29 states have some form of medicinal cannabis laws in effect with 8 states and the District of Columbia being out right legalized for recreational use.
The federal government still has cannabis listed as an illegal schedule I substance with no oversight by the FDA for regulation. With a serious need emerging for regulation, stakeholders in the budding cannabis industry turned to ASTM International in 2015 for a committee to be formed to create standards. ASTM being an internationally recognized body of professionals that lead the way in creation of standards for industries throughout the world for basically every facet of manufacturing, finally accepted the task in 2017 and created D37 the committee on cannabis. For stakeholders in the industry this was a huge step forward in the recognition of cannabis and its legitimacy as a therapeutic drug with widespread medicinal use.
D37 is the officially recognized committee on cannabis with the inaugural meeting on June 11-12, 2017 in Toronto, Canada. The committee is composed six subcommittees to cover all aspects of manufacture of cannabis which was agreed upon during the meeting to vote and create the committee at ASTM headquarters.
The six subcommittees cover indoor and outdoor horticulture and agriculture, quality management systems, laboratory, processing and handling, security and transportation, and personnel training, assessment, and credentialing. Each subcommittee is chaired by a leader in each respective field.
Those involved in the inaugural meeting all agreed that this is a pivotal point in the industry and the upmost care shall be taken in the development of these standards. Careful consideration will be placed on each and every standard and all stakeholders see this committee as the prime example of what cannabis will be in the next decade.
ASTM has chosen to lead the way in bringing cannabis from the taboo underground into the forefront of horticulture manufacturing. D37 will bring standardization into a medicine that so many already desperately depend on and a medicine that so many more need. ASTM has recognized the flaws in an industry that most have a difficult time acknowledging as a legitimate medicine but understands the more information that is available the more likely it is to be accepted. Cannabis is no longer in basements and closets but controlled in multi-million dollar state of the art greenhouses. This will be the medicine of the 21st century and eliminate the dependence on opioids that are destroying so many lives. Stakeholders of the industry see this as the way in to the future and the help so many need.
Cannabis cultivation is a manufacturing process that is very different than most products that make their way to shelves for consumer purchase these days. Medicinally grown and recreational cannabis are no different in their processes that brings the seed to a high-quality product that is ready for sale in a dispensary. The only difference lies in the requirements to be considered a patient in a medicinal state or in fewer circumstances an adult consumer in a recreationally legal state.
Although cannabis is a different type of manufacturing process it is not unique. Industries that also have similar long term processes include aged alcohols such as scotch, whiskey, and fine wine. Even though the final products are different, the operational requirements are very similar. These industries require a high capital expenditure to cover the costs of equipment, operational space, and other start-up costs. Unlike other industries that spread the cost of the initial expense over thousands and possibly hundreds of thousands of items that come to market quickly after the processes begin, cannabis will have additional months until a viable product can be sold to recoup some of the initial losses of initial start-up costs. Even with high volume manufacturing applications the return on investment (ROI) is several years if not more, however, in the case of cannabis this ROI period can be even longer. The path to positive sales and achieving ROI can be completely rerouted if a single crop does not make it to market.
The long cycle time between seed germination and sale of cannabis flower gives countless opportunities for problems to occur that could ruin the entire crop. The cycle time can be defined as all the value and non-value added activities that bring the product from seed to sale. The nature of the cannabis flower and the means of consumption creates a somewhat unique circumstance for what can cause a crop to be scrapped or discarded. The time in the growth cycle that problems arise can severely impact the likelihood of recovery.
Generally, in growth and vegetative stages the plants have much more potential to recover from nutrient deficiency or pest infiltrations. This is due to the fact once in flowering stage pesticides should be avoided at all costs and any nutrient deficiency will harm yields since the shorter time-period of this stage does not allow for the plant to achieve its maximum potential. At no point in the process should it be necessary to use pesticide if careful considerations are taken to eliminate pests in the first place.
Risk mitigation is the best approach to being proactive in the unfortunate event a pest infiltration does occur. Cannabis plants in different stages should always be segregated from one another in order to reduce the risk of losing an entire grow operation. Creating physical barriers along with carefully considered flow paths reduces the risk of pests from one cultivation stage to another. HEPA filtration and environmental monitoring can reduce the spread of pathogens which are more difficult to control in connected facilities. This creates an environment where the lose of a single stage only creates a set-back of weeks not months and limits the turnaround time due to sanitization and root cause analysis to hundreds of square feet instead of the entire facility.
Being proactive is the key to success as the feedback loop of cultivation is slow and determining when the crop is beyond recovery can be difficult. The point of no return will vary depending on the situation considering the uncertain nature of horticulture. Well trained employees are key in the identification of problems as cannabis is absolutely not a store-it and forget it industry like those mentioned earlier. Cannabis has a consistent addition of value added activities through the entire grow cycle. Value added activities can be identified by the inputs that a customer is willing to pay for such as watering and nutrient additions since these activities are vital to the growth and well-being of the plant. However, even these activities can cause problems without careful considerations.
Good Manufacturing Practices (GMP) and Quality Management Systems (QMS) can all but eliminate all of the problems discussed. Long term manufacturing processes such as cannabis are perfect for the application as risk mitigation and risk analysis of activities are key aspects of these programs. Orion GMP Solutions specializes in consulting and assisting cannabis growers and processors in avoiding these pitfalls through quality by design. Cannabis cultivation is a process unlike most others but can be managed to produce consistent results without many of the risks that can make failure an option. Orion carefully considers all aspects of the process and can help businesses proactively manage their process by reducing risks to tolerable levels so that success is achieved. Risks can never be fully eliminated but careful planning and designing the process with quality in mind means businesses can plan for success.
Oregon’s recreational cannabis market experienced its first recall of cannabis this month after cannabis flower containing high levels of pyrethrin was sold to the public. The Oregon Liquor Control Commission (OLCC) issued the first recall of recreational cannabis after BUDS 4 U notified the commission of contaminated cannabis flower. Samples of Blue Magoo failed for the chemical pyrethrin when tested at GreenHaus Analytical Labs. Several breakdowns of the quality system in each tier of the distribution system occurred for this recall to take place.
The root cause of the recall stemmed from the application of pyrethrin. This chemical is a widely used insecticide for soft-bodied insects and is considered to have low acute toxicity in humans or mammals. The fact it was applied indicates a need to eliminate insects. In no case should a pesticide be applied without cause. If it is necessary to eliminate pests, it is the responsibility of management to minimize the introduction of pesticides that will adequately eliminate the pest and preserve the quality of the cannabis.
Insects are foreign bodies that should not be present in cultivation operations when proper quality management systems (QMS) are in place and strictly enforced by all employees of the operation. Proper quarantine and Quality Control (QC) testing of raw materials such as grow mediums or nutrients should eliminate the presence of foreign bodies. Any outside materials that introduced to the cultivation room or greenhouse should be quarantined before being used and be required to meet quality assurance specifications that ensure contamination risk is eliminated.
Proper environmental controls ensure that the physical cultivation areas are maintained in a way to eliminate the introduction of pests. Requiring employees to change from personal clothing reduces the probability of inadvertently introducing pests from outside environments. Insect nets on regularly inspected external vents or air circulation systems reduces the chance for introduction of infestation into the cultivation areas. Regular inspection of physical structure for damage or deterioration reduces risks of outside pests being introduced to the operation. The preventative measures listed offer some examples of what can be done to eliminate the introduction of pests into cultivation areas, however sanitization between harvest batches must be performed as a primary preventative measure. This ensures that the room and all equipment will not be the source of contamination.
From a QMS point of view, the most serious breakdown of process is the release of cannabis that was not verified by approval of the operation’s quality assurance department. This harvest lot or batch should have been segregated and properly quarantined until specifications were met. It is the responsibility of quality assurance to certify that all products have met the entirety of the specifications, including pesticide residue, before releasing for shipment. Approval and verification of meeting product specifications before batch release is the most vital duty of any quality assurance department.
Not only was the batch released from the cultivation facility without being properly certified, but the distributor was careless enough to release the product to a dispensary without completing their own quality assurance checks to ensure the products in their control were properly tested and that all specifications were met. The dispensary is also partially to blame, but it should also be praised considering it initiated the notification to the OLCC and started the recall process. If proper checks were in place through the QMS system this would have been caught and the public’s safety would not have been at risk.
QMS only works if every aspect is strictly enforced and followed to the letter. Each operation has the responsibility to verify all specifications and checks are made when the health and safety of the public is at risk. Adherence and certification to the FOCUS Cannabis Cultivation Standard is an easy route that cultivation operations can take to ensure all products meet specifications. Recalls can be the quick end of a company, and meeting the guidelines of this certification is one way to ensure that business will continue to prosper. FOCUS Standards are set by leading experts in the fields of quality management and can help ensure the safety and health of all those receiving cannabis related products.
References:
Gunasekara, Amrith S. “Environmental Fate of Pyrethrins.” Environmental Monitoring Branch, Department of Pesticide Regulation, Sacramento, CA, 2004.
I want to take a moment to give praise where it is rightfully due and shout out to the mad scientists over at Skunk Pharm Research out of Portland, OR. Graywolf, Joe, and Carla (Eloquentsolution) discuss the popular topics on the subject of at home cannabis products and how to SAFELY go about creating them. It is the responsibility of the readers to not attempt activities they are not qualified to perform. Being an engineer myself I completely agree with this point of view. We can’t stop others from being stupid and limiting ourselves in an attempt to protect the less than Einstein group of people – that is just going to be futile in the end.
These guys do a great job of not only giving abundant details on how to go about recreating their Frankenstein Cannamonsters, but go above and beyond explaining the science of the processes and the reasoning that makes it work. This is definitely not the norm in this space and most individuals just want to tell how awesome the contraption they came up with is, and how they made 3x the yield of any known process. Not the case with these guys, they are upfront, open, and honest about their creations. My take is that they are here to help spread knowledge and make the world a better place one extracted cannabinoid at a time. We actually have many clients that quote their research and have directed us to their articles when discussing various extraction methods and why they chose to go that route. It is very humbling to see so many people getting information from a group that claims to be experts of nothing but are obviously very gifted in the realm of engineering.
The subjects are generally focused on different extraction techniques and the methods to go about replicating them. Their most recent article was on the subject of health and safety highlighting the fact that small amounts of contamination can be a big problem when you get into concentrates. This blog is never limited in the amount of useful information it produces and the wide range of topics covered.
We look forward to many more great articles and hopefully getting to meet up with them discussing how many wrong directions someone can take or the fact people never fail to surprise you with idiocracy. Intelligence should never be wasted but ability will always be the limiting factor. For now check them out at Skunk Pharm Research LLC.
Don’t forget to check out Orion GMP Solutions for updates on GMP’s in the cannabis industry.
