GMP Documentation for the Cannabis Industry

nik-macmillan-YXemfQiPR_E-unsplash

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 1: What is GMP?

DSC00047

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

Pressure gauge

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

The Importance of Certification for Pressure Vessels

Air tank with pressure gauge.

Do you work in an industry where the use of pressure vessels is common?

Then, explosions may be something you worry about. You want to stay safe at work and go home at the end of the day in one piece. Have you ever looked at a vessel and wondered how it can keep its pressurized contents safely in place? Who makes sure that these vessels are safe? Have you ever noticed the stamp or plate on a vessel and wondered what it means?

Let's find out!

What are Pressure Vessels?

If you don't work in a field that routinely uses pressure vessels, you may not know what they are. Simply put, they are containers that hold pressurized contents.

This means that the container holds its contents, either a gas or a liquid, at a different pressure than the atmosphere. It is critical that this vessel maintains its seal. Otherwise, the sudden pressure change will cause an explosion.

The vessels were originally invented to handle the steam needed to operate a steam engine back in the day. But now these vessels are very useful for a variety of applications. Everything on the following list uses these vessels in some manner:

  • Recompression chambers
  • Mining operations
  • Nuclear reactor vessels
  • Distillation towers
  • Submarines
  • Spaceship habitats
  • Petrochemical plants
  • CO2 extraction systems

These vessels are also routinely used for storing liquefied gases like propane, butane, LPG, chlorine, or ammonia.

Safety

As you can imagine, safety is a huge concern with these vessels. If you've ever popped a balloon with a pin, you have an idea of what would happen if a pressure vessel suddenly lost its seal.

Safety is the number one reason why proper certification is so important. The American Society of Mechanical Engineers (ASME) put into place their rather stringent standards in 1914. Before this, working with these vessels was very dangerous.

The vessels often failed and exploded. These explosions often severely injured or even killed anyone that was nearby. Obviously, this was not ideal. So the ASME put into place inspections and certifications that these vessels had to pass.

It didn't start out this big, but now the ASME's code encompasses 28 books and over 14,000 pages. It covers residential and industrial boilers and every pressure vessel imaginable.

It is an international code that everyone should adhere to. After all, it doesn't matter where you are on the planet. Physics is still physics, and a vessel will still explode under the same miserable conditions.

ASME Certification

Not all these vessels are created equally. They can handle a wide range of PSI. Thus the ASME construction code has different standards that apply to the vessels. Regardless, though, any vessel that will handle more than 15 PSI is subject to the ASME code.

The vessels are divided into three groups. Those that handle up to 3,000 PSI, up to 10,000 PSI, and those that handle pressures over 10,000 PSI.

The ASME has guidelines for the types of materials that can be used to build these vessels. Some requirements apply to all vessels. Others only apply according to how much pressure the vessel will handle.

Once the vessel has been approved, it gets a stamp or plate that boasts ASME certification. Many insurance companies will only cover a company that uses pressure vessels if every vessel has this ASME certification.

Of course, it's possible that any pressure vessel can fail. Don't assume that a vessel is foolproof just because it has been certified. But, meeting the certification standards greatly reduces the risk of failure and a potentially serious tragedy.

Good Design

In addition to the materials that can be used, the code also covers how the vessel should be designed. The ASME clearly lays out design standards that a vessel must meet or exceed to get certification. Even the shape of the vessel is essential for proper construction.

This also extends to the fabrication process. Manufacturers should follow certain procedures during fabrication that will help ensure the integrity of the vessel. Manufacturers must also follow a quality control regimen to ensure that the vessels they produce are solid.

The ASME also keeps an eye on the manufacturer's track record. The vessels that a manufacturer produces must consistently meet the ASME standards.

Transportation

While a pressure vessel can explode at any time, they are particularly dangerous during transport. The vibrations and jostling about that happen during transport can be just enough to cause the vessel to fail.

Imagine the devastation if a vessel explodes on a public roadway.

For this reason, the Department of Transportation also gets involved here. They issue an R-stamp that is very important. If a vessel needs repairs, the welder must have this R-stamp certification.

The welder (and the shop) have to undergo strict testing to receive this certification. Once they obtain it, they have to stay in good standing with the National Board of Boiler and Pressure Vessel Inspectors.

Improper repair of these vessels is a hazard to the public that is taken very seriously. This certification ensures that everybody stays safe.

Stay Safe

Who knows how many lives have been saved because of the ASME standards. But the only way to ensure that they keep saving lives is by following them.

Now that you know what ASME certification is and why it's so important, it helps to ensure that your vessels meet all the codes and standards. If you see a pressure vessel in use that doesn't have the proper certification, say something. You could potentially save someone's life.

Would you like to learn more interesting tidbits about chemical or mechanical engineering? Be sure to check out our education page. We've got great bits of interesting information about the exciting world of engineering.

INFOGRAPHIC | The Dangers of Butane

Stay Safe when you're extracting

Each week, more and more of these explosions make the news. Take a look at some real headlines from the past couple months alone.

Despite being an effective solvent for cannabis, butane is flammable and dangerous. Countless individuals are severely injured every month due to butane extraction labs, often located in densely-populated residential areas.

 

Butane Explosions

INFOGRAPHIC | Safety First – Does Your Pressure Equipment Have This?

Worried about your pressure equipment?

Certified equipment is vital to the continued success of your business.

Take a look at our infographic to learn about some of the certifications required to stay compliant and operational.

Certifications

Licensing and Regulations for Extraction Efforts

Cultivation of marijuana , cannabis sativa , flowering plant as legal medicinal drug , herb , ready to harvest

Demand for high-quality cannabis extracts is surging. Fresh recreational and medical laws continue to burst into existence. Nearly a dozen states are considering adopting pro-cannabis laws this year.

Old-fashioned extraction efforts are blazing back into popularity. Supercritical CO2 extraction has long been a staple in the food and beverage industry. Cannabis manufacturers, however, have historically shied away from the expensive method. Until now.

The cannabis industry is booming; a lot of growers and manufacturers are flush with cash. Cannabis connoisseurs crave variety at dispensaries.

CO2 oil is popular because it's a pure, clean substance that's devoid of the usual harsh solvents used to create cannabis concentrates. States with legalized cannabis have introducing licensing and regulatory rules for cannabis concentrates.

This post will delve into the basics of supercritical CO2 extraction methods and explain the regulations guiding extract artists in their work. Keep reading to find out more about CO2 oil and the laws surrounding it.

What is CO2 Extraction?

Supercritical CO2 extraction processes take advantage of a bizarre property of carbon dioxide (CO2). Extreme pressure and temperature are combined to force the CO2 beyond its critical point.

Supercritical fluids have features midway between a gas and a liquid at the same time. While in this volatile state, supercritical CO2 is an ideal solvent. It breaks down the plant structures in cannabis and allows the technician to isolate cannabinoids and terpenes, chemicals in cannabis that affect the human body and brain.

Traditional cannabis extraction efforts rely on harsh, flammable solvents.

Licensing and Regulations

The cannabis industry has been legitimized. Strict rules now govern cannabis manufacturers. Most states have licensing and accreditation requirements. They also have standards that must be met before the cannabis can be sold.

Laws change drastically by state. States with legalized recreational cannabis seem to have the most robust regulatory system. For instance, California law states that: "Every person who manufactures cannabis products shall obtain and maintain a valid manufacturer license from the Department..."

Cannabis professionals that want to produce CO2 oil in most states need to be properly licensed. There are additional rules about the product itself. A lot of states with legal cannabis require that it be tested by an independent laboratory before it reaches dispensaries.

CO2 extraction efforts should produce a clean extract that's free from contaminants. States with lab testing requirements check for pesticides and bacteria as well as other impurities.

Volatile vs Non-volatile Manufacturing

State regulators worry about flammable, volatile solvents. California law separates cannabis manufacturers based on their extraction efforts. You need a different license to produce butane hash oil than CO2 oil. California lawmakers split manufacturers into two groups, distinguished by their use of volatile or non-volatile solvents.

According to last year's Medicinal and Adult-Use Cannabis Regulation and Safety Act, a volatile solvent "is or produces a flammable gas or vapor that, when present in the air in sufficient quantities, will create explosive or ignitable mixtures."

CO2 is a non-volatile solvent. California cannabis manufacturers who use a professional CO2 system to create their extracts would be considered Level 1 Manufacturers. Extract technicians who worked with chemicals like butane are Level 2 Manufacturers. It's more difficult and more expensive to apply for a Level 2 license. Few California neighborhoods allow Level 2 cannabis facilities.

California law isn't a federal dictate, but the state's cannabis market is now the largest in the world. Smaller markets look to California as an example.

Problems with Butane Extraction Efforts

Consumers are wary of butane. Last year, California legislators passed a bill that treats butane like a serious drug. Gov. Jerry Brown eventually vetoed it, if he hadn't the state's butane hash oil producers would have gone out of business. The bill limited the amount of butane a consumer could purchase each month and required dispensaries to keep track of people's usage. "This type of 'point-of-sale' regulation works," the bill's authors wrote. "It has a proven track record in the detection and dismantling of methamphetamine labs..."

Denver, Colorado was the first city to slap regulations onto the butane hash oil process. Engineers analyze new facilities to make sure that they're compliant with the law. In 2014, 32 butane hash oil explosions were reported in Colorado alone.

Manufacturers using CO2 are scrutinized as well, but the regulations are less burdensome. Manufacturing CO2 oil-based cannabis products is often cheaper and easier than using butane.

Benefits of CO2 Extraction

Cannabis is heavily regulated. The law, however, is friendlier toward to certain types of extraction methods than others. Butane is risky. Ignoring the health risks of ingesting the chemical, labs that work with Butane are at risk of blowing up.

That's why so many California counties are okay with manufacturing facilities that use CO2 to create cannabis extracts but are reluctant to approve labs that use flammable solvents. Creating butane hash oil is dangerous if you're not experienced.

California, Nevada, Colorado, and Washington all have rigid regulations and licensing rules controlling their legal cannabis market. Other states are adopting similar laws.

CO2 oil is preferable to other cannabis-infused products because its health benefits appeal to consumers and regulators alike. It's an FDA-approved solvent that's doesn't harm the environment or the human body.

Find Out More

Supercritical CO2 extraction is an increasingly popular way to produce high-quality cannabis concentrates. It's a pure method that produces terpene and cannabinoid-rich extracts without sullying the product with potentially toxic materials. Cannabis growers and concentrate manufacturers who want to satisfy a diverse client base should look into producing CO2 oil.

To learn more about supercritical and subcritical CO2, browse through the CO2 Science section of our site.