I definitely vote that discussions on GACP are underrepresented here. Would appreciate a thread that covers the common pitfalls you see with successful GACP implementation? Could load this on the following thread: Where does Global GAP stop and GMP start?
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Excelent thread topic
This is actually a dependence on national regulations and end user specs.
In some cases it can be gacp drying that is justiified for extraction purposes, but I have never seen an outdoor crop that would qualify for pharamceutical flos use(vaporizing).
More like you can make a flowr ouside and into a GMP processing/processing.
I also would be happy to have someone to talk about the extraction GMPs with primary crude - SPD - chromatography…
Would it be possible to construct a GMP for naturak products of golden extracts… Since its so dependent on the variabilty of plant mater i think it highly doubtfull to justify this. When making cbd isolate 99.7% is much easier to achieve .
Sry guys dont wanna derail, i see this is a common practice here on f4200( noofense to anyone) 
Something like 30% of all pharmaceuticals start with plants. Almost all excipients start with plants. Which means almost all of the drugs we consume start with plants in at least the “filler” that is formulated with the active ingredient.
This happens all the time. The plants are no more specialized that the cannabis plants being grown right now. But the processing is more controlled - and because its at a large scale with margins acceptable in the 5-10% or less level (no one in cannabis wants margins that low…even though that’s great compared to almost every other commodity out there…) people spend the time to get things ultra-purified.
There are still bad actors, just like there are in cannabis. But the regulators help weed those out with good feedback loops from consumers, both wholesale and individual consumer networks.
Even hormones are made with starting materials that come from big Ag and big Oil - both which start out as unpurified materials and get nicer and nicer the more time is spent on them.
Anyway - I digress. The only reason people are not doing this in cannabis (I mean some are…) is because they don’t HAVE TO do it yet. Consumers are still pretty meh about and not enough people have been harmed to make the regulators step in and correct the “free market” system.
I fully expect broader regulation in the next 5-10 years, maybe sooner if we keep getting more and more states going MMJ/REC. And the FDA has already stepped in for CBD (saying no to interstate commerce until these things can be controlled) so half the industry is already there.
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Thanks for thinking of me Sacextraction!
I am on the business development side of things and we have a pharmaceutical team (both internal and externals) here in Europe engaged. On the technical side, we engaged someone from the community here (I will withold their name for now!) for the development of GMP SOPs, sourcing of equipment, validation, policies, etc. All of this is to be converted into EU GMP certified processes from the team on our side.
We’re early days in our project and its scope. I don’t mind giving my two cents at a high level.
The biggest thing I would say @TMcz - I wouldn’t try to accomplish EU GMP certification anywhere outside of Europe. It is costly, time consuming and the risk of failing an audit are high - especially in the cannabis industry, which is not as broadly understood by auditors as you would hope. Ie: travel time and costs of European Health Authorities, European pharma consultants and QAs, etc.
Dovetailing from the above - if you are looking to export into the EU from LATAM, I think a more realistic approach would be to focus on GMP compliance and not necessarily certification. You may want to find a pharmaceutical partner somewhere within the EU that can import, QA Hold / Check / Approve / Release a GMP certified product.
On the practical side - I’ve found that licensed European wholesalers here are more willing to talk to you if you’ve pharma operations in Western Europe (no offense to my Macedonia and Slovenian friends).
Not sure if the above helps or sounds like bullshit, up to you to decide. Good luck!
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extraction GMP (SOPs in practice) are mainly separating the processes, i.e. rooms for each: storage, grinding, extraction, recovery, purification (and here I am in a current argument stating that Distillation equipment and Chromatography equipment can be in the same room, others disagree), WIP storage, storage, etc etc etc. Then all the equipment and connections and HVAC and pipes and all that need validation, then the processes need to be tested and validated to consistency, and then you need to dispose of it all and clean it all and train everyone and, and, and. Batches run everything - when to show up for work, when to run, when to stop, when to clean, everything sorta has to be broken down into manaegable chunks until consistency is achieved.
And this is where things really get hard. Consistency. Hard to explain to someone that 10,000kgs of 15.3% CBX verified by COA will give us different results in mass and potency of crude/dist, even from run to run, or day to day until all of it is done. They expect (want?) us to say that the first bag of 20kgs run will match within a very small variation the very last 20kg run of that Batch of 10,000kgs, and that each and every bag run was consistently the same and produced the same results every time. Every shift will do Xkg and produce Yliters of precisely Z.01% CBX and EXACTLY 0.1999999% THC…
Yeah, there be hoops to jump through.
Is there any official check to GMP “compliance” , or is that just what you say and then send anyone who asks an outline of what you do?
I’ve always wondered how much credit statements like “We manufacture to EU GMP Standards.” or yours, “We comply with EU GMP regulations.”
In reality, what does that entail and mean? Are those terms regulated like ISO certs and auditors?
There’s nothing for GMP compliance that I know of, other than reports from third party auditors (ie: SGS)
For EU GMP certifications, if they are not listed on EUDRA, then they’re likely not certified.
You are very much on the nose. Statements such as these are misleading and should be called out as bullshit in relation to EU GMP status/certification:
“We are GMP compliant”
“We manufacture to…”
“We comply with…”
“In accordance with…”
For what you’re particularly looking to do @TMcz, the ONLY thing that matters is “GMP Certified” with a follow up as “Yes, we are listed on EUDRA” which is publicly accessible by anyone with an internet connection.
Please do note - most of the customers and clients we distribute to here in Europe (or even to Canadian brokers - ew) ask for EU GMP because that’s what they THINK they want or need. More often than not in the OTC cannabinoid marketplace, purchasers have no idea what they need or are looking for.
There is crazy demand right now for registered APIs in Europe. There are just very few suppliers in Western Europe. Further to that - anything based in the UK right now is in a precarious position given Brexit.
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I would say this is due to inconsistency of 10.000kg biomass can be a problem aswell. The top of thw bigbag will be 15% but how many samplea were taken to estimate this?
The botom 1000kg will definetly be difderent since there is diffreences inside such voluminous bathces… So in terms of this you have a problem keeping up the needed consistency… The biomass your getting should be then packed in 20kg bags where every single bag should have a HPLC /GCMS test that is compliant iwth herbal drug standards (its +/-10% in declaration of the genetics producer i think). Meaning you need a fscility that does inhouse testing on a validated method and does acresdicted testing regulary.
Hop in if I went to crazy but if you have things storages in bigbags of 100+kg then less analitycs can be done.
This is what I mean by isolate repeatability because you have a finalizing proc3ss that is really repeatable. Probably easyer to justifiy in the end run.
I hope your succesfull
It might mean the product is just packed in GMP laboratories, and everytrhing else is just a natural hemp product… I see products that are cbd isolate food grade but packaged in gmp and they get the necesary stamp thats a marketing trick… The insides are no more quality then OTC as jimmy says…
As long as its listed on CPNP and your local inspectors arent to vigilante your fine.
Austira for example is a good market right now, peoples acceptance or mct and smoking cbd flowers is very popular and they sell at least 150mio-200mio per year if not more in cbd related products… They better sell the organic stamp than gmp cause of the peoples appreciation for organic(bless sep holzer). missing a good market research actually…anyone…? .
Yep, what we are trying to work through with the material coming in and all the variabilities we can encounter. And yes, a lot of that is on the shoulders of the supplier. I never thought of testing per delivered bag, and ours having to match each bags results…
How would you break down a 1000kg+ order from a single farmer/source to then keep Batches as large as possible due to having to fully clean between Batches for GMP? Same farmer, same strain, same delivery, and let’s say a system that does 250kg/day. I want 100% of the material to be a single Batch so I only deep clean between farmers/deliveries. Then everything within that 1000kg+ gets produced and homogenized and we have a single GMP product from all that material. But it seems we may have to make smaller/different Batch definitions, clean more often for no real reason, and have added analytical tests to pay for. Any ideas on how to approach?
Oh how I love this conversation.
You do this by using ANSI/AQL Inspection criteria, collecting a lot of different samples, mixing them together per bag, and taking an aggregate of your test results. This is for in-process / incoming material - and it can usually be done with in-house equipment. These are not the certified test results that many states and countries require.
This method will get you a more homogeneous sample and you can use statistics to be more precise on your process mass balancing. The samples are minimally destructive (a couple of grams per bag) and you use special tools to be able to collect portions of a sample from all parts of the bag or bale. They have sampling thieves specially designed to do this work, that either collect plugs from tightly bound material or snag scoops from loosely bound material.
The batch will remain the same - so you don’t need additional cleaning unless you want to do so for mechanical efficiency. You will do more analytical tests - but the method for collecting the sample, homogenizing, and testing could really still be a single sample, it will just be less accurate.
So a 1000kg order using this type of table for the statistics - you would inspect and take samples from 80 locations. You decide how you want to determine a location. But let us say you have 50kg bags - so 20 bags worth. And you need 80 locations. So you could take 4 samples from each of the 20 bags or you could take 8 samples from 10 bags. You could also use the number of bags instead of the weight and collect instead the number of samples from the stats table. So if you had 20 bags you’d collect a sample from 5 bags - I’d use a sample thief that collects top/middle/bottom to do this, personally. Or I’d go with collecting 8 samples from 10 bags for more locations for better homogeneity.
In any case - there is a method. It is used in most industries and I’ve had it work both in hemp with large quantities and in MMJ with small batch sizes (less than 10kg).
The lot number stays the same. The sample results aggregate to give you better control of your mass balance - and you are off to the races. There is also precedence for this method in the EU GMP - so you are not bringing them something they have not seen before.
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So do you think that we can setup our side to meet the compliance needs of a company that can then ‘upgrade’ what we make to full GMP Certification (wherever they are located)?
I can tell you this much—it is easier to acquire compliance at any level when utilizing a quality by design (QbD) approach.
If you’re looking to certify a facility/process that’s already up and running, it’s going to be much harder to accomplish anything.
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The short answer is: yes.
The long answer is: you’ll need a pharmaceutical partner in the EU zone that you can trust and work with in the long term.
I’ll DM you 
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Yes. We are designing ground-up and have had to adjust quite a few things to comply. Mostly OK to deal with when under construction. But there are a few things I’d hate to have to certify legacy systems and all that. For example, I don’t think an investor will want to hear that the whole HVAC system will have to be scrapped and will try to get you to use existing ‘whatevers’ as much as possible to save money. And then still have to re-do it all with new equipment…
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What’s your HVAC situation like right now? DM if you want, I don’t want to derail the thread
Ours is pretty awesome. 5 zones. Trox air units. 95% installed. And I actually have a present situation going on that is pertinent: Just discovered a couple doors opening the wrong way for fire egress (in, not out). Wellllll…doors like that are partially held shut by the different air pressures for different zones. Can’t just turn the door frame around. So even though we built by design…we still got a simple thing wrong and now have to get…sigh…creative.
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Wow, thank you! I’ve seen similar done in EU. The team here thought it was funny when I suggested we go to the farm and test the bags there onsite before putting on a truck to speed things up and control delivery. This will help create an outline for that.
We are starting out vertically integrated with a large GaCP/GAP GH nearby. So we will be able to control those tests and get them to package how we want and it all should be a lot easier to begin with. But we need the ability to purchase other material, so, will need to develop these SOPs for other material.
I’ve wondered if this point is almost an opportunity for a middleman to jump in and take material, test it, deseed, destem, homogenize/grind, package neatly, deliver on time. Seems like that all could be a business in and of itself for the GMP needs.
I second cassian.
You shoul take probes that are able to reach bottom bags of the bigbag.
Testing on site was a practice at our prevoius firm where we took up to 10kg of samples carefully takeb from different sites of the bags in quwstion. Probes for soil sampling came in real handy.
Performed a nonseperated and seperated biomass analyiss to weigh the feasability of post processing and the losses/gains of cannabinoids when extraction procedures occured. It had alot to do with economic factors in the end ofc and wuality of the crude.
Your team laughs at you but you are spot on, sincea couple of hundred € for 3rd party lab test is nothing compares to a grossly overestimated yield in the end. And you get to see the facilty and you can question their GAP/GACP storage for parsmeters of quality and protection against insects or vermin…
Middle man has to be squeaky clean and copliant so he wont fuck up your process with the other auditors that might be too inwuisitive…
So if you already have a somewhat cGMP operation but need more Quality SOPs to help get you across the line - the QMS Shopify site is now up and running for Quality Management System documentation - this is where you can buy the documentation that you need to run your cGMP operation from a Quality standpoint. Call us if you need help with the rest - Store | Compliance by Design
We wrote these QMS docs for small pharma companies and our clients use this QMS for exactly that purpose.