The EU-GACP (Good Agricultural and Collection Practices) and EU-GMP (Good Manufacturing Practices) are industry standards very strictly applied to medicinal products wanting to be imported into the EU. This does not just apply to cannabis but to all imports. A lot of cultivators, especially those coming from the underground and emerging countries, do not see the use for this and some even prefer to ignore it. When it comes to the importing part and their crop gets left behind in the warehouse due to incompatibility, they are upset. We have broken down the whole argument, the reasons and how it can give you and your product an edge. Read it now or be sorry later.
Why the GACP and GMP and adhering to these regulations is important
Rules, laws and regulations form the basis of a stable society, but it goes far beyond that. They are so entrenched in our way of life that we don’t even notice them anymore. It has become part of our behaviour. Adapting to change is one of the primary foundations on which the survival of mankind is based.
GACP and GMP guidelines help us structure our work and should not be perceived as authoritarian because it protects those who are in need and suffer from an ailment, the patients. Understanding why these rules exist is the first step to a successful growing business.
The EU is the biggest market in the world. Germany’s demand at the moment is one ton per year. Within the next four years the demand will rise to between 300 and 400 tons. Those who want to benefit from this growth need to understand and abide by the rules.
Rules are not unique to the cannabis business. Standards, audits and certifications are used in all sectors of the economy to prove that the requirements for the defined best practice are implemented.
So let’s start off with seeing what purpose these regulations serve.
The GACP standard applies to the cultivation and some processing steps of cannabis. As a rule, the compliance/conformity is verified according to a checklist by a third party and recorded in an audit report.
The aim of the Good Agricultural and Collection Practices (GACP) is to regulate everything that you are doing to the plant as you are growing or cultivating it, up and until the plant is cut. This is where patient safety comes in, preventing harmful contaminants such as pesticides, heavy metals and microorganisms. Cannabis is being grown as a medicinal plant to be used as raw material to generate a herbal medicinal product.
The main objectives of these guidelines are to contribute to the quality assurance of medicinal plant materials used as the source for herbal medicines. The aim is to improve the quality, safety and efficacy of finished herbal products.
GACP guidelines were developed to create a single supranational framework to ensure appropriate and consistent quality in the cultivation and of medicinal plant and herbal substances. They then provide a basis for homogenized national or regional standards for the cultivation and collection of medicinal plants.
GACP guidelines should always be read in connection with Good Manufacturing Practice (GMP) guidelines. Remember that the quality of an herbal medicinal product starts at cultivation.
The Good Manufacturing Practice (GMP) are the rules that generally kick in during post- cultivation. One should want to know that the product has been treated with care to the standards that they determine.
GMP sets basic requirements for medicinal products. These apply to herbal products such as medicinal cannabis because of their often complex and variable nature. Herbal substances that are destined to be used in pharmaceutical products must be of suitable quality and supporting data needs to be maintained to document satisfaction of the requisite quality standards.
The goal of the GMP guide is to provide guidance for the manufacture of active substances and finished medicinal products under an appropriate system for managing quality. In this way, it helps to ensure that active substances and the finished medicinal products meet the requirements for quality and purity that they purport or are represented to possess.
Where GACP and GMP overlap
It is important to understand that cannabis is grown as a medicinal product and is therefore subject to the rules and regulations of the pharmaceutical industry.
To go in more detail when it comes to the overlap between GACP and GMP, one should have a look at the table depicted in the EU-GMP Annex 7:
The pharmaceutical industry is one of the most demanding industries in the world in terms of compliance requirements and the cultivation and manufacture of medicinal cannabis is inseparably linked to such standards.
Where products are to be delivered into the medicinal market, GMP standards are mandatory. It is the manufacturer´s responsibility to ensure that the appropriate GMP classification is applied. The major objective for a manufacturer in applying GMP standards is to make sure that safety, quality, and efficacy of the product are not compromised, whilst also minimising business risk.
Companies entering the market need to ask themselves whether they want to focus purely on growing cannabis or handle everything from cultivation to manufacturing and distribution. Companies that plan solely to cultivate, which primarily falls under GACP, could opt to partner with a 3rd-party p manufacturer that is GMP certified. Forming such a partnership might even bring a final product to market faster, by enabling both the cultivators and the manufacturer to focus on what they do best.
If you are a cultivator trying to sell your crop to a manufacturer, you have to comply with GACP Guideline. If you don’t, you won’t be able to sell your product because if it is not shown to be compliant, it is unusable in the pharmaceutical industry. Should you decide to also get involved in the extraction/manufacturing process, you have to comply to GMP guidelines if you want to sell it. If you don’t, you won’t be able to sell it.
Vigilance beyond certification
Documentation and transparency in fulfilling the data integrity requirements
The effectiveness of these audit and inspection processes are determined by the reliability of the evidence provided. It is critical to the audit and inspection processes that auditors and inspectors can determine and fully rely on the accuracy and completeness of evidence and records presented to them. In a nutshell, the need to document every single step or activity can be summarised in a simple sentence:
Say what you do (SOPs, procedures, templates)
Do what you say (records, registries, forms, etc.)
The ability to trace, secure and simplify transactions along the entire cannabis supply network is of utmost importance. Proof of conformity and compliance for the newly emerging cannabis industry are essential to establish trust and to create transparency in this young and opaque market.
The role of artificial intelligence (AI) and the Internet of Things (IoT) in smart monitoring cannot be overemphasized. This involves fitting the farm and plants with sensors that gather data about the plant, its environment, and nutritional needs. This data is then transferred to the farmer, who takes the necessary action. By using AI-based and IoT devices in farms, cannabis cultivators can identify problems in plants and how to treat them properly. Each plant can be assigned a bar code or QR code to monitor its improvement over time and also suggest what is needed to make it grow optimally.
As a decentralized system, employing blockchain in cannabis has a way of tracking the physical properties of cannabis as it moves through the supply chain. With this, patients could independently verify the quality of the cannabis plants and products, thus increasing efficiency and compliance.
GPS tracking devices can verify the origin of a plant and show the authenticity of each product. This is something farmers can use to determine the safety level of cultivating the plants and know what to expect after cultivation.
Doing things manually may be the old school way of doing it, but transparency is so much easier to prove if you have technology to help you.
Proof of compliance as a competitive advantage
The days of putting a couple of pips in the ground and hoping for the best, is long gone. Administration, record keeping and science is what creates a successful product. This process is helped along with transparency. By taking the lead, you will automatically have an edge over your competition. When the right documentation supports a healthy crop, it means a successful business. It also means less bureaucratic hiccups and a smooth ride.
The bottom line: if it isn’t written or recorded it didn’t happen’
Why patients/users are more likely to engage with a product whose production chain is transparent
When you use medication in any form, you instinctively trust it because you are aware of the strict quality control it is exposed to. Never will you think twice about the safety of the blood pressure tablet that you bought at the pharmacy. The reason you trust this tablet is because of the credibility that the pharmaceutical industry has built up over the decades to find themselves in a position where their supplying of a product automatically makes people feel secure.
The cannabis that you supply into this chain, is subject to the same rules and therefore subject to the same trust as the blood pressure tablet.
Vigilance goes beyond certification
At the end of the day, there is another aspect though: vigilance. Working in a young industry where there is a lot of resistance to its acceptability after years of propaganda by science, media and politicians, the process is not just centred around building a new industry, but also about building trust in that industry. This trust can only be built if those who work in the industry can be trusted – to do the right thing, to adhere to the rules and to not cheat in any way.
If you rely on a platform in which you can track everything you do, it not only becomes reliable but also traceable by the bureaucracy that you will inevitably deal with. In terms of GACP you can have a data record of every single thing that happened to that plant all the way to being cut to stem. You can now see what’s been added and if everything has been done correctly and even more importantly you can show your partners and also to patients that it falls within the required standards. On the GMP side of things you can show everything about how the product has been handled during manufacture. You will have a document of everything that has affected the plant and you can use it for transparency. It’s audited, it’s there. This not only makes your business successful and compatible with rules and regulations, you are also actively contributing to building a new industry from which both yourself and the industry can benefit.