This is the script of a speech (titled GACP CERTIFICATION FOR HERBAL MEDICAL PRODUCTS) that our MD, DIego Sala, had in the 4th CISW MedCann Investment Summit World (Medical Cannabis Investment Summit), held in Bangkok on December 20th, 2023, in the Hotel Intercontinental.
GACP CERTIFICATION FOR HERBAL MEDICAL PRODUCTS – a speech by Diego Sala
First time we heard of the intention of DTAM to implement GACP certification in cannabis medical sector we honestly underestimated the impact that it was going to have.
This standard will drastically change the cannabis market in Thailand, and I will widely justify this assertion in next minutes.
We are really in a premature phase, where everything is allowed and not regulated yet.
Most of you are anxiously waiting the issuance of Cannabis and Hemp Act, hoping that it will show the way.
No, it won’t show anything new. The new law will put the ball in the Court of Thai FDA, and more precisely to the Department of Traditional Thai Medicine saying, as in many other cases rightly said: “you are the expert, please regulate all this”
The nice thing is that the DTAM really already regulated all this, and we already know how.
So, everything is ready and the bet is: will the parliament approve the law and keep considering the cannabis as a herbal medicine, or they will destroy a project ongoing since 2019 where many influent families invested hundreds of millions and where institutions worked so hard for two years?
GACP certification for cannabis exists, and this is a clear indication that the most real scenario is the first: keep moving as medicinal herb.
GACP LITERATURE
GACP certification is a quality and safety standard mainly based on European GACP Guidelines.
There are many concerns on the level of such standards in international community.
I would not be worried about this, since standards seems to be solid and based on international guidelines. I wold be more worried about the international competition of Countries with a huge surplus of cheap product, but this is another story…
These are the reference sources that DTAM used to create their manual titled “Thailand Cannabis GACP”. It’s a manual to support the local growers in order to produce cannabis with the purpose of medical use and for export.
This data gathering started in June 2019 and finished in 2023, so it has been done partially when the product was still a narcotic, not yet a medicinal herb.
In the slide, I divided the sources: in red the domestic literature, in green the foreign literature. Source of foreign literature is from Canada, Europe, Australia, Japan. The main document, GACP guidelines, is inspired by WHO and EMA (Europe Medicine Agency).
What does this mean?
Two main things:
1. that in the same time the “internet experts” were desperately crying that the new government would have kicked back cannabis in narcotic section, the competent Authority was clearly considering it a medical herb.
- That the final target of Thai government is to become a research and production hub mainly dedicated to export, and that Thai GACP has been designed to be compatible with all the importing Countries.
This will be the end of the Far West period, where everything is allowed as we have seen in last 18 months.
WLECOME TO GACP
GACP certification is not coming out of the blue. It is being introduced in Thailand to make local production competitive outside the Country as medical product and to give rules internally in order to regulate the local market and consumption.
This second scope is hidden behind the word “quality and safety”, but once we read the requirements is comes clear that GACP will give an enormous hand to regulate the actually hidden markets with the concept of total traceability, that will force growers and sellers to follow rules, use authorized product an give a guarantee of safety to the consumer.
WHAT IS GACP CERIFICATION?
GACP is a quality and safety standard.
This is the official definition provided by DTAM:
Good Agriculture and Collection Practices are plantation-level standards to serve as criteria for farmers to safely grow herbal raw materials and to certify their crop through internal inspection processes to reach international standards.
GACP certification covers the venue (soil/building), the workers (from their hygiene to their health and welfare), the process. Process is not terminating at the time of crop. GACP in fact covers also the cleaning, selection, packaging, storage and loading of the product. We can say that GACP covers until you load the truck outside your warehouse. From this moment, the product is not under your responsibility anymore and is covered by GMP standards.
WHY GACP?
GACP standards are aimed to provide safety to you, your workers, the consumers. Don’t forget that we’re talking about medicinal herbs, used for health treatment. It is totally normal for the Authority to do all is possible to secure the safety of products that in one way or another are ingested by humans. Working daily with FDA I see how many efforts they do to secure the consumer’s safety.
Let’s open a parenthesis on the definition of medical herb. The product is a medical herb independently from the use they make of it.
What they sell in dispensary is a medical herb, regardless the way of assumption into the body.
Nothing is still decided, but my bet is that dispensaries shall be compared to pratictioner’s clinics and cannabis flowers will need a prescription. This will draw the final line on the definition of buds: medical treatment.
As medical herb, GACP will be a mandatory requirements.
If my assumption is right, dispensaries will need to require the GACP certification to their suppliers. The system is already running, with the obligation to report to Provincial FDA monthly purchases and sales through form 27 and 28. Next step may be the total traceability. Let’s see what happen…
WHO MANAGES GACP?
Like every quality standard (ISO 22000, HACCP, GMP, BRC) every manufacturer, in our case the grower, has to assess his plant for a verification of the process.
All the process is controlled by the Department of Traditional Medicine, a department of Thai FDA.
DTAM is, by their own words, a “temporary” Certify Body. For the moment they are handling directly the inspections, but they spoiled that in the future they will create a network of Certify Body, and they will become Authorized Body, the final controller. Actually, even DTAM needs to make experience, since this standard is new for them too.
GOOD AND BAD OF GACP
The good is that finally the sector shall be regulated in the entire supply chain, protecting the consumer and making the Thai cannabis products reliable internationally and good for export.
The bad is the volume of headaches you will have to implement the standards in your companies and to adapt your standards to the requirements.
Someone will have an easy task, with just some small amendments, someone else will have to restructure heavily his activity to avoid to lose competitivity or worse being pushed out of the market.
GACP CERTIFICATION STRUCTURE
Like every quality standard (ISO 22000, HACCP, GMP, BRC) every manufacturer, in our case the grower, has to submit his plantation for a verification of the process. This is first documentary: all paperwork to guarantee safety of working area, raw materials, water, land, and to avoid cross-contamination; then, an SOP ( Standard Operating Procedure) has to be created in paper or electronically. Last, the plant is physically inspected by the Certify Body for final approval.
I spoil a number for you: DTAM made some test cases with 8 grow venues in October, and result was that only 2 plantation were compliant.
Main obligations of the operator under GACP standard
- Entrepreneurs must keep records of the purchase and the use of materials (water, fertilizers, etc.) in the grow area, record every activity and the sale of products.
- Entrepreneurs must keep documents and make continuous records of raw material certificates, orders, purchase invoices, pest control, prevention, etc.
- Keeping all documentation ready for an inspection by officials, and allow them eventually to inspect the facility including grow, storage, offices and all the area
- Immediately notify the Authority in case of changes in standards, species and the location and eventually amend the license.
- In the case where the entrepreneur hires full or partial space to a contractor, such contractor must comply to GACP and get relevant licenses.
THAI GACP vs. EU GACP
A common question: is Thai GACP compatible with international standards? Can we export with our local certification?
Final answer shall be at the end of this topic. For the moment, let me tell you that this is the structure of Thai GACP that is commonly known, compared to the European GACP.
As evident, the topics are almost the same, and I guarantee you that also the details are extremely similar and totally compatible. I would say that the Thai regulator put more attention to details, as common in our culture…
Another personal consideration: Quality Standards are internationally regulated by WHO guidelines, and for this reason accepted worldwide regardless the Country of issuance. Therefore, Thai GACP is expected to be enough for export and should be accepted by third Countries.
A detailed article on this topic is HERE
GACP CERTIFICATION IMPACT ON THE MARKET
How GACP certification will impact on the market?
The main impact is positive: it will allow Thailand growers to export their product as medical herbs. Actually, Thailand is not exporting medical cannabis for lack of quality and safety standards.
A second consequence is the regulation of supply chain: GACP requirements impose the use of registered and legally imported products: from seeds, to fertilizers, to soil.
Let’s open a parenthesis on seeds and fertilizers.
I was in DoA at the end of November. They told me that just few batches of seeds have been imported through the official channel. Same for fertilizers, just few brands obtained an import license, and organic can’t be imported. But in reality most foreign growers want to use foreign brands…
There’s evidently a parallel market caused probably by the high volume of documentation requested. Registration is complicated and some trader may have considered alternative ways.
With the enforcement of GACP, that will make mandatory the traceability of seeds and fertilizers, growers will be allowed to use only registered products. Many companies are already moving. My advice is to move in time, if you didn’t move yet.
I would not consider the process as an increase of cost, since in the middle term following process will optimize the work flow and help to control costs and production capacity. I would consider GACP an investment more than a cost.
GACP DATA MANAGEMENT
Is data management another headache?
Like every quality standard certification, GACP will add a number of actions to your normal routine that you may not have considered before.
Manual data management can be indeed an headache.
In the same way you use a software to control temperature, moisture, Co2, and water flow, you can use a software also to produce documentation for traceability and cover all the requirements.
Our partner Company GACP Asia signed an exclusive contract with a software designer to distribute their cannabis-dedicated software in Thailand. I’ll be able to explain you more in case someone of you is interested.
GACP vs. Medical GMP
The market of our reference today is medicinal production.
This sector is strictly regulated by Medical GMP, that is not part of my topic today.
The important thing is that the two standards, even if totally separated, are strictly correlated.
Let’s see how.
This is the screenshot of Annex 7 of GMP for Medicinal Products. This standard is issued by the Pharmaceutical Inspection Co-operation Scheme (PIC/S) and represent the Golden Standard in medicine sector worldwide. This annex covers the production of herbal medicinal.
Well, it clearly prescribe the use of GACP for plants used in production of medicine. According to the small note in the table, GACP must follow WHO or EMA guidelines that have been followed by Thai regulator.
Therefore, Thai GACP will be compliant with Medicinal GMP. See more HERE.
CONCLUSION
Summarizing, GACP certification is our new travel mate and it will be probably applied to the vast majority of the projects in this sector.
It will impose huge changes in the grow, regulating the full supply chain. It will make the raw material fully suitable to medicinal production. It will enhance the export capability of local production.
GACP is not an option, is a mandate if you want to use or sell your product for medical purpose.
Ignoring GACP in this moment could be a hazard.
If you want to kick-off your certification process, you can perform a free self-assessment by clicking HERE.
