@Micah any MRPs that you have been impressed with for GMP certification? OR “fairly” less expensive “ERPs”?
I love me some Master Control QMS. Easy to use. Easy to setup. Not terribly expensive. Part 11 compliant. And it comes with validation documentation.
Plus it does almost everything except inventory / order placement…and you could build that in if you wanted, probably.
3 Likes
Hello everyone how are you, I would like to revive this conversation.
I am currently in the same situation that TMcz was in. We are a small company located in Latin America and we are finishing the process of construction and adaptation of production areas, we have 316 stainless steel equipment, and we will dedicate a specific room for each of our processes (Grinding, Extraction, Winterization and filtration, distillation, and finally purification), we already have the process established and at this moment we are rewriting documentation in all areas related to the implementation of GMP.
As such, we have not started production yet but we are at capacity at the moment, what has stopped us is obtaining the certifications (which I am still not very sure if it is necessary to obtain them in advance).
But, like many, our investors want to start production now and market as soon as possible and roll out the changes as we generate revenue. They want to opt for a vision of these extracts as if it were a raw material or semi-finished material, but, as I have been telling them, we need to address which customers this raw material is going to be sold to (food, pharmaceuticals, cosmetics,… .) in order to establish the standards and quality requirements.
I understand that it is necessary to be able to market with pharmaceuticals a GMP certification, for the other types of product I am not clear.
My specific question is, if it is possible to start production of extracts, is it necessary for us to be certified in good manufacturing practices? Or is being licensed for production enough to start producing?
The market they seek is to reach the United States and Europe.
Interesting. For our industry is complicated to correctly reach the US with extracts in a GMP setting with all the appropriate documentation, as normally that documentation comes from the FDA and it is not available for our industry.
However, lots of people don’t care too much about these things. And what they really want is a third party audit to come in and say that your company meets normal GMPs.
For the EU - you’ll be looking at slightly different rules than that US - and you’ll want to get a PIC/S audit, that will work for just about any country that is part of the EU, and probably also for the UK. But you’ll still need qualified person for importation of many things. That person usually lives in the EU and this is what they do, sign on saying that they agree you are making things correctly for importation.
You could always start producing but not be able to import until later. Its possible that “later” could be a long time depending on what products you are making and where you want to send them. Each country / segment of countries is a little bit different.
You should get yourself a compliance officer (if you don’t have one already) the are required for the GMPs (you have to have Quality Assurance and Quality Control, its in the definitions of GMP <3)
There are companies that do these certificate programs and they exist for food/beverage, cosmetics, organic, Kosher, etc. So you are very right that you should be looking at WHO you want to sell things too, and then meet their specific needs. This is HUGE - not doing it could mean you make a bunch of stuff that doesn’t have a home.
There is quite a bit of competition out there for these kinds of things as well - so knowing your niche or niches and having a plan for the level of quality, packaging, and importation requirements will be important.
Feel free to hit the DMs if you want to chat about it more.
2 Likes
Thank you very much for the help and collaboration. I will bother you with more questions about it
@Cassin is a great resource and does excellent work for her clients. If you are considering a consultant in this realm, you’ve found it in Cass.
1 Like
Hi, I had to recover my account, I haven’t been here in a long time…
@Cassin Cassin pointed out most of the relevant stuff. I’ll give you a bit of South American experience along these lines.
Getting THC containing products onto a ship and sent overseas is a complicated process of paperwork. The whole process of GMP sorta deals with preparing all of that, so, if you have GMP, and someone on the other side has a certificate in their country that allows them to receive THC, then all is good. You really need to follow the path of transportation to get an idea of what you need before a truck pulls up and loads your stuff. If your investors believe you can ship kilo’s of extract, or pallets of products, without jumping through all of the regulatory hoops, you need to be able to give them the real story. Just because we all feel cannabis should be treated differently, in the eye’s of international law, you might as well be making opiate painkillers to ship to Europe.
The problems you may run into are the differences in the certificates and licenses needed by different agencies. Are you licensed through the Ministry of Agriculture AND the Ministry of Health to do what you do? While some Ministries of Agriculture get the ball rolling for you to grow and process cannabis, the Ministries of Health jump in to control things a bit more, and then the Ministry of Industry & Ministry of the Environment will want to control your facility. And since most countries are starting with ‘medical’ cannabis, that means all the checkboxes for medical production need to be met. And once met, they constrain you. e.g. a medical cannabis license only allows you to make GMP products - you may not be able to make CBD supplements, for example, unless they are run through the whole registration process that a THC supplement would need as well. We were thinking to make CBD dog treats to get us started with everything thinking it would be easier… Nope. Full denial by the powers that be. We were either able to make products that a doctor(or Vet in this case) could write a prescription for… or nothing.
What you mention brings to mind a GMP certification issue, the basic rule of 3. You need to fully test your whole process start to finish 3 times, and meet all of your quality standards during all 3 runs, to get the final certification. Once received, you can then retroactively request that those 3 batches tested to be fully certified as GMP. So you don’t have to waste 3 batches to get to certification. But if you fail that certification, then those products made will need to be destroyed. And each product needs this. Plain extract, capsules, tinctures, etc all need to be individually certified after 3 full batches.
As Cassin says, WHO you sell to will help guide the direction, and if they are big enough, they will have people on their side to help you make sure everything runs smoothly. And they may need you to run through their home country certifications, e.g. Israel has its own set of certifications, so you need to fly someone over to check your processes and sign-off before they will accept delivery there.
Last point- this shit is expensive! Getting a consultant in to help with just your GMP documentation can easily be $35k-$50k. What started this whole thread was our QA person jumping up and down about getting the equipment certified by an outside consultant who wanted to charge us $40k for a single line of document preparation. And we faced similar throughout the whole time. Consultants to check that our floor paint and walls were GMP compliant, IT consultants for CFR-21, HVAC consultants, etc. And the employee positions required, like a qualified QA person, also can hit in different areas. One that shocked me was a Ministry of Industry requirement to have a certified steam-vessel engineer for our falling film evaporator to be sitting in front of the damned thing whenever it was running. Tripled the salary requirement for a ‘line worker’ with just that.
Unfortunately, in my experience, this is not something you can do 99% for the long-term. You really need to have perfection to do everything your investor’s spreadsheets are saying they want. And that takes time & money.
If you have any specific questions, DM me as well.
2 Likes
Hello how are you, thank you very much for taking the time to answer. and as you say, this is regulatory madness. We have been consulting everywhere possible but this whole process is still very ambiguous to me.
Our plan is to obtain derivatives only for the cosmetic industry, supplements and ultimately medicinal, so we thought it was a little easier to be able to market the product without the need for a GMP certification to support it, since it is considered as an intermediate product. We also had animal feed in mind to capitalize on, but with what you told me, I don’t think we’ll achieve it yet.
It seems very frustrating to me that they limit you to a single type of market (medicinal) and have to comply with everything related to this in order to export or market in Colombia.
Is there no way to market the product without having to comply with the GMP? that is to say, all the production lines have to be purely medicinal and therefore comply with GMP?
or for all types of product do we need GPM? or what requirements are necessary.?
Thank you very much again for the message.
I will be asking you more questions for sure
There are 100% other products that come from this plant.
Building materials
Paper
Cloth
Rope
Cooking oil
Hemp hearts seeds for food protein for humans and animals
Fuel oils for biofuels
Almost all of those things have their own path to market. They dont require the same constraints as medicial ingredients or dietary supplements.
Are those an option for you?
1 Like
First off I think that thinking big with gmp is the wrong attitude
Think small I received eu gmp (food)
On a lab that’s 40 square meters
And all machinery is up to eu gmp standards but small so from the rotavape to the extraction vessels
It s all small but certified eu gmp
Now once the certification is provided
Scaling is a lot easier a lot
1 Like
Back to check responses and this is really neat. 40m2 is tiny! How did you achieve such ‘separation of processes’ in such a small space? We were battling with that due to mainly HVAC issues and positive airflow, etc, needing special doors and transfer boxes that took up a lot of space between each process. Does it include incoming areas (quarantine) and storage and all that? Or is it a portion of the process in a facility that has all the rest (changing rooms, etc)?
We were tossing these ideas around for portable labs in shipping containers, but thinking GMP was too excessive a goal for that. Haven’t been doing this for a while now, so just academically curious.
“Is there no way to market the product without having to comply with the GMP? that is to say, all the production lines have to be purely medicinal and therefore comply with GMP?
or for all types of product do we need GPM? or what requirements are necessary.?”
What is your license/certification for? If it is medicinal, then you need to be making medicine. And that is where the bottleneck occurs. I wished we could have made GMP during the day, and dog tinctures at night, but learned that just wasn’t possible under our license. I think I referenced it above, but we started the journey with the Ministry of Agriculture licensing and thought all would be possible, but then the Ministry of Health wanted their tithings and threw a wrench into the works and locked-in the medicinal part.