A cornerstone of commercial medical Cannabis cultivation is the production of consistent and compliant plant-derived material.
Controlling and ensuring quality standards whilst ensuring a lean manufacturing process are essential features of a successful medical Cannabis business. However, achieving these goals in a rapidly emerging industry that brings together experts from different fields can be challenging.
In this article, we discuss how standard operation procedures (SOPs), as an essential component of a quality management system, can add structure to your production process and help your operation achieve consistency and compliance.
One of the biggest challenges of complying with regulations in medical Cannabis is engineering practical solutions that work for cultivation staff but also comply with the interpretation of the guidelines as implemented by quality management staff.
We therefore also take a look at the value of working with experienced cultivation consultants that can help bridge the gap between staff in the cultivation department and quality professionals who are more experienced in the pharmaceutical industry.
GACP and GMP Guidelines
Good Agricultural and Collection Practices (GACP) guidelines provide a set of standards which cover the cultivation of herbal plants for medicine from their cultivation up to the point of harvest.
In the medical Cannabis industry, those looking to achieve the gold standard of pharmaceutical manufacture must comply with Good Manufacturing Practice (GMP) guidelines.
As a minimum, this is from the point of harvest onwards and includes post-harvest processes such as trimming and drying through to packaging, extraction and additional manufacture of Cannabis derived active pharmaceutical ingredient (API).
From a medical standpoint, GMP guidelines define what “high-quality,” Cannabis means. The aim of these guidelines is the production of safe and consistent pharmaceutical-grade Cannabis and its derived medicines.
However, both GACP and GMP guidelines are not prescriptive but rather require a degree of interpretation.
This can cause difficulties in the drafting and practical implementation of the documentation that forms part of a quality management system. There is also often a bridge between cultivation departments whose staff are often from an agronomy background and staff from the quality department who are used to navigating the waters of the highly regulated and strict pharmaceutical industry.
A Growing Problem in an Emerging Industry
Medical Cannabis is a nascent industry, and its production varies significantly from other more mainstream herbal medicines that are cultivated under GACP guidelines e.g., calendula, echinacea and valerian root.
This is one reason why even experienced professionals from the pharmaceutical industry can find it challenging to design a quality management system for a medical Cannabis facility. Here, the need to design documentation that fulfils both GACP and GMP standards but is at also a practical solution suitable for the effective production of high-quality, consistent and compliant medical Cannabis can be a challenge.
Further, there is also no single “industry standard” approach that has proven to be "the best" for the production and manufacturing of high-quality medical Cannabis. In fact, several methods for its cultivation exist including outdoor, greenhouse and indoor with further variety within each of these e.g., LED vs HPS lighting, inert vs organic substrates and wet or dry trimming.
This lack of standardisation continues in the manufacturing process once plants are harvested and make it more difficult for staff with no prior experience of working in commercial Cannabis facilities to design a quality management system that describes, records and assesses essential procedures related to its cultivation and the manufacture of its subsequently derived medicines.
Much of the knowledge base and technical expertise required to grow high-quality Cannabis in Europe is not in the pharmaceutical sector, but among legacy growers, farmers that have been working in historical producing regions either legally or clandestinely. These growers are slowly entering the industry and introducing their cultivation and processing techniques to the pharmaceutical sector. For them, working within a pharmaceutical framework can put much stricter regulations and expectations with regard to various aspects of cultivation including equipment, consumables, and acceptable techniques.
Trying to find the middle ground that exists between working with a living organism that has a natural microbiome and professionals from a sterile pharmaceutical background can present major obstacles. Particularly, trying to standardise a medicinal plant so it produces a consistent and predictable level of the relevant therapeutic compounds is hugely challenging.
Even in spite of using tools such as plant cloning, meticulous control of the growing environment and frequent chemical analysis as part of in-process cultivation testing, it is still difficult to achieve a process that produces functionally identical plants throughout the year and from batch to batch.
The Role and Importance of Standard Operating Procedures (SOPs)
One essential part of a facility toolkit that can help improve production processes and benefit standardisation are standard operating procedures (SOPs).
All the cultivation processes which describe the procedures followed during the growing and manufacture of medical Cannabis-derived medicines should be covered in SOPs which clearly describe all processes taking place from “seed to sale.”
Some of the essential cultivation SOPs that are mandatory aspects of a quality management system include:
Cannabis Propagation – Seeds and Clones
Generation and Maintenance of Mother Plants
Maintenance of Vegetative Plants
Maintenance of Flowering Plants
Integrated Pest Management
Plant Quarantine and Destruction
Cleaning and Sanitisation of Cultivation Areas
Important features of effective SOPs are that they are clear, concise and accurate meaning they are frequently updated to reflect as closely as possible the procedures used during the execution of these tasks in your facility.
SOPs are often one of the first items that are used to train new staff at a facility. In fact, some quality management systems state that employees cannot conduct tasks like propagation or fertigation until they have read all relevant documents, attended practical training and have this logged in their employee file.
Having new employees attempt tasks based on instructions referenced in SOPs is also an excellent way to put your procedures to the test and ensure they are a true reflection of your processes.
The Value of Working with a Cultivation Consultant
Provision of SOPs and complementary documentation including work instructions, which capture additional detail references in SOPs, and forms and logs, often form part of a licence application process.
Even after being granted a GACP licence, obtaining GMP certification remains a major challenge for agricultural companies that want to enter the medical Cannabis industry. This is due to the fact they no longer operate only in the field of agricultural production, covered by GACP, but must meet the much stricter GMP standard in the pharmaceutical sector as well.
What makes it even harder to meet the GACP and GMP standards for newcomers is that these standards are only formulated as guidelines, which do not define exact courses of action.
Therefore, should you want to build and run a production facility for medical Cannabis, we highly recommend working with consultants that have the combined knowledge of legacy Cannabis growers, agricultural experts and specialists from the pharmaceutical sector.
This can accelerate your route to license approval and market authorisation as you receive SOPs and additional documentation such as work instructions, forms and logs that combine the expertise of relevant parties.
This documentation is designed to ensure the effective production of the highest quality medical cannabis and forms the basis of employee training.
Importantly, delivering training based on cultivation SOPs is a valuable step in ensuring your quality team and other pharmaceutical specialists fully understand the cultivation and post-harvest processes and all its related procedures. These SOPs are also integral for risk management and mitigation strategies related to optimising your production process and facilitating effective troubleshooting.
Finally, SOP-based training is essential for ensuring the quality management system and its associated documentation are user-friendly and offer practical solutions for ensuring your operation stays compliant and runs smoothly.
Documentation remains part of the toolkit that can ensure lean manufacturing in medical Cannabis facilities and ensure consistency with regard to achieving a compliant and high-quality product.
A cultivation consultant can collaborate with a facility’s quality management staff to draft documentation including SOPs, work instructions and forms and logs that are demanded by medical Cannabis regulatory bodies.
Having input from subject matter experts with technical expertise in the design, use and application of documentation can accelerate a company’s license application but also be an invaluable resource used to train new staff across multiple departments.
Big Leaf Consultants offers a documentation drafting service designed to provide bespoke and tailored solutions for your facility’s quality management system. Our documents have been third-party-checked and approved by the quality management staff of various facilities. We offer reworkings and customisation and can also provide feedback on any existing documentation.
Big Leaf Consultants can also deliver training sessions for quality staff to help them understand the cultivation and post-harvest process in an effort to more accurately determine the most practical solutions for essential data capture and record keeping.
To know more about these and the other services we offer, get in touch with us today.