Well-designed cannabis production workflows can help business owners understand the benefits of efficient and secure operating procedures in Medicinal Cannabis cultivation and production/manufacturing.
When it comes to the production of pharmaceutical-grade cannabis products and extractions (medicinal marijuana products), errors are extremely costly. A mistake can lead to crop damage, excess waste, higher cultivation and production costs — even product rejection and product recalls due to cross-contamination or other cultivation and production disasters.
This is why efficient, well-engineered facilities and workflows are crucial to medicinal cannabis business operations, from cultivation through to distribution, including pharmaceutical extraction processes, domestic manufacturing and GMP requirements for cannabis exportation to global markets.
Mistakes in Workflow Designs for Medicinal Cannabis Cultivation and Manufacturing
Mistakes in workflow designs are not only expensive, but they can also lead to regulatory failures serious enough for you to lose your ODC licence or related permits for cannabis cultivation and pharmaceutical production.
So why is workflow such an important part of cannabis cultivation and manufacturing operations, and what does it mean, exactly?
Definition of Workflow in GMP Pharmaceutical Manufacturing
Workflow Definition | Medicinal Cannabis Production/ GMP (Herbal Medicines Manufacturing)
Workflow definition – a sequence of steps designed to move a production process from beginning (for medicinal cannabis, that’s the seed source or plant clone) to the end (final product delivery). Each aspect of cultivating cannabis, including harvesting and drying, and producing medicinal cannabis products, will need a designated, well-engineered workflow for (a) efficiency, (b) sterility and plant protection, (c) regulatory compliance (source quality, quality assurance and validation across the life cycle, environmental controls and testing, contamination testing/pesticide-free testing, validation, tracking, storing, labeling/packaging and more).
- Cultivators and medicinal cannabis and hemp product exporters can’t afford mistakes with their facility and clean room designs.
- Nor can they risk inefficiencies or other workflow problems during cultivation/crop management, laboratory extraction, batch traceability/quality testing and data-recording procedures.
Employees and contractors must also follow highly-regulated security and safety procedures during medicinal cannabis product storage and transportation (distribution), known as good distribution practices (GDP), an increasingly hot topic in GMP training courses and pharmaceutical industry forums.
More on workflow below…but are you needing help getting into the medicinal cannabis industry?
PharmOut’s cannabis consultants can assist you with licensing applications, medicinal marijuana processing and regulatory requirements for GMP / EU GMP (PIC/S). Our pharmaceutical facility design architects, cleanroom validation, testing and processing engineers are experts in assisting cultivators and medicinal cannabis manufacturers with environmentally-minded designs for efficiency and GMP compliance. Contact PharmOut with your enquiry or view the top 10 medicinal cannabis blogs.
To understand the impact of workflow on GMP, you’ll need to first understand the basics of GMP
** Seminars on Medicinal Cannabis including presentations by Maria Mylonas on GACP and GMP for herbal medicines **
PharmOut’s Learning and Development Director, Maria Mylonas, the world’s best GMP trainer according to hundreds of GMP training reviews, was invited to be a Guest Speaker at the combined Schimadzu/Scitek Medicinal Cannabis Seminar series held in August 2019 around Australia.
Cultivation and processing for medicinal cannabis | The importance of workflow
The world’s best cannabis consultants must have extensive knowledge of the complexities of cannabis; including designing buildings, laboratories, storage facilities and pharmaceutical production processes that meet PIC/S compliance requirements, all while controlling costs.
Production Considerations including GMP, GDP and the impact of Workflow
The best time to implement efficient, GMP compliant workflow processes and procedures is at start-up. Your initial site selection, facility design and cannabis SOPs will all have an impact on your productivity, compliance, sustainability and profits. The second-best time to improve your workflows is during a renovation or expansion. But it’s much easier to engineer (or build-in) compliant and efficient workflow systems right from the start of your cannabis business, and there are many benefits in doing so.
The least desirable time to adjust your cannabis workflow designs and processes is when you’ve failed an audit, lost a crop — or worse yet — lost your cannabis permits or your license.
It’s much better to get expert cannabis consultancy right at the start; so that you’re well informed about the regulatory compliance matters that will impact your cultivation and operational function; with PharmOut’s experts in GMP, validation, pharmaceutical manufacturing SOPs, cleanroom designs, automation, GMP and CAPA training, and GDP.
Our engineers and expert cannabis consultants regularly help pharmaceutical producers remedy their PIC/S compliance issues; including training or re-training employees and contractors in GMP, GDP, GACP, GDocP and more.
With so many start-ups emerging in the potentially lucrative medicinal cannabis industry, it’s best to seek workflow design assistance at the beginning of your business start-up; not once you’ve spent millions, only to find out that you’ve gotten something wrong — or costly — in cultivation or production.
This includes seeking expert consultancy on-site selection, architectural designs, validation and engineering processes, data integrity evaluations and distribution security.
Some common issues our architects, GMP engineers and expert cannabis consultants work to overcome for clients include:
- Indoor grows are incredibly expensive, especially in colder climates
- These plants need 12 hours of light a day — and power is increasingly expensive, especially in Australia
- Outdoor crops (open-air) can also be difficult to fully control and/or insure against potential losses, such as pests, fires, floods, cross-contamination, other disasters
- Plus, interception of high-quality medicinal cannabis is a recognised risk during storage or transportation. If GDP isn’t followed precisely, your product could be unsellable or stolen; or substituted for fake cannabis or other substandard-grade products
Your product labeling must also accurately reflect the product content, doses, contraindications and other risks, meeting the country’s regulatory requirements for labeling (e.g., the TGA or FDA auditing standards for labeling requirements).
Cultivating quality medicinal-cannabis plants — and exporting medicinal cannabis products including extraction products — is extremely complex
- Workflow is crucial to efficiency (controlling cultivation and production costs, eliminating wastage); quality and sterility; and other GMP and EU GMP (PIC/S) requirements
- It has an important role to play in quality monitoring as well as being a vulnerability for TGA and FDA audits
Some key steps in medicinal cannabis production workflow, which are covered at upcoming seminars in August (Australia-wide), include:
- Raw Material Testing
- Plant to Extract
- Product Quality Assurance Testing
- Growth and Extraction with CO2
- Calibration Standards for Cannabis Testing
- Extract to API
- GACP/GMP – understanding the regulatory requirements
What can happen if your crop management and operational facilities, operating systems and procedures, laboratory processes, GMP and GDP aren’t well-enough engineered? Or if they fail a TGA / FDA / EU GMP or PIC/S compliance audit?
The answer is you could incur serious penalties, as well as crop losses or risk your licenses and permits.
Failing to yield a viable quality medicinal product is fraught with problems, including the sustainability of your business. Depending on the reasons for failing to yield a high-quality medicinal cannabis product, you might even find your ODC / TGA or FDA cannabis licence(s) and permits canceled or suspended, not to mention the damage to your organization’s reputation.
There’s also the risk of not meeting your contractual deliverables if you’ve entered into exportation agreements (for example, for the USA, Germany or UK markets).
A significant crop loss, as well as financial burdens, can occur in relation to poor workflow designs. Without adequate workflow consideration at the start of your facility and processing designs, you could end up with significantly higher expenses and/or higher crop loss risks. You could find yourself with serious waste management issues, not to mention financial distress, contractual breaches and/or the loss of cultivation and processing licencing for your cannabis company.
About the Past Cannabis Seminars
- 1-Day medicinal cannabis industry seminars (past event).
- Scitek and Schimadzu co-hosted Medicinal Cannabis workflow seminars
- Held in major cities in Australia on August 2019, starting at 8:30 am and end around 4:00 pm.
PERTH | Location: Bentley, WA | Monday | 19th August
BRISBANE | Location: near Brisbane Airport | Tuesday | 20th August
MELBOURNE | Location: near Monash Conference area | Wednesday | 21st August
SYDNEY | Location: Olympic Park | Thursday | 22nd August
Read our top 10 medicinal cannabis industry blogs.
Past event – PharmOut’s Learning & Development Director, Maria Mylonas (the world’s greatest GMP trainer) was a featured speaker on GACP and GMP regulations in pharmaceutical cannabis manufacturing settings.
Page updated on October 28, 2019.