Top 5 Reasons to be UE GMP
When it comes to the United States, the legality and regulation of CBD is relatively straightforward under the 2018 Farm Bill. In the EU, however, regulations of CBD vary greatly making GMP compliance a more complicated conversation overall. Much like the FDA, the European Medicines Agency has regulations in place that regulate the use of CBD as a food or medicine product, but depending on the country itself, EU GMP compliance is widely different.
For example, while CBD is considered an illegal narcotic in Sweden, but is considered to be a novel food in Spain. These discrepancies are widespread throughout the European Union, so what is the point of putting in the effort of being EU-GMP compliant?
In this episode of extrakTALKS, Dr. Jon and Randall Thompson discuss the top five reasons to be EU-GMP in the CBD industry. Among the top five reasons in this episode are: Access to a 500M population, Taking advantage of a country by country EU market that is continuing to grow, opportunity to implement a pharmaceutical quality system that will increase the professionalism of your own company, Differentiation of your company, and Building consumer confidence in a quality product. Listen up if you are interested in tackling the opportunities of EU-GMP compliance in the ever increasing CBD market.
LISTEN to this episode:
[00:00] – Welcome!
[07:19] – Overview of EU-GMP
[08:27] – Top 5 Reasons for EU-GMP
[13:43] – ISO
[18:42] – Health Products Regulatory Authority
[23:44] – EU Regulation of Hemp
[31:35] – Novel Food Application Requirements
[34:50] – EU-GMP Regulations for Cannabis & Hemp
[38:44] – EU-GMP Certification
[45:01] – EU-GMP Post Certification Inspection & Coordination
[47:42] – Basic EU-GMP Requirements
[49:00] – What is a Pharmaceutical Quality System?
[50:24] – Key Elements to EU-GMPs
[51:36] – What is a Qualified Person?
[52:45] – Risk Management Process
[55:16] – Risk Assessment Tools
[56:56] – Failure Mode, Effects, and Critical Analysis
[57:10] – Risk Ranking & Filtering
[59:37] – Top Reasons Against EU-GMP
[65:11] – Final Words
Randall Thompson 00:34
Hey, welcome. Thank you for being here. We love having you here. Today is going to be a great show.
Dr. Jon 00:41
Randall Thompson 00:41
Hey, welcome. We got a lot going on man. And by the way, Ignacio from Stockton won a whole package, he took our hemp survey, and one of them one himself a pack of relief. CBG seeds
Dr. Jon 00:57
is also known as the Cheetos Daddy,
Randall Thompson 01:00
is it the Cheetos daddy?
Dr. Jon 01:02
Randall Thompson 01:02
Is that how you say that? How would you say that Ignacio, let us know. Yeah. Shout out to Ignacio.
Dr. Jon 01:07
That’s pretty sweet
Randall Thompson 01:08
and correct our pronunciation of Cheetos daddy. Okay, so good job. So take our surveys be there. There’s a lot of people wanting to know about our topic today, which is good. today. We’re talking about the top five reasons
Dr. Jon 01:23
Randall Thompson 01:23
To be EU GMP compliant.
Dr. Jon 01:26
Randall Thompson 01:27
Dr. Jon 01:27
Randall Thompson 01:28
That’s what you want to do. So we’re This is going to be covering topics with the European Medicines Agency. Oh, by the way, GMP is good manufacturing practices.
Dr. Jon 01:36
Randall Thompson 01:37
EU is European Union.
Dr. Jon 01:39
Randall Thompson 01:39
Right. So Europe, there’s a lot you know, and those are the things that come in ancillary would be novel food, you know, risk assessment. There’s a couple of things. One that you’ll see out there is good automated manufacturing practices which are there or GAMP, five, sometimes they call it, we do full GMP training. One of the things that Dr. Jon made me do when I got here was go through GMP certification. Yeah. Everybody does. Well, so we’re that’s the other things IQ oku do word.
Dr. Jon 02:10
Randall Thompson 02:12
Dr. Jon 02:13
I q o q pq,
Randall Thompson 02:14
the multi lingual here.
Dr. Jon 02:17
I got it. Okay. You want acronyms? We got acronyms.
Randall Thompson 02:20
Oh my god. We do have an acronym.
Dr. Jon 02:24
We got those to
Randall Thompson 02:27
So some of the things that we’re going to cover today have operational qualification all of these things so please bear with us ask the questions. This is vital because we’re getting this asked of us every day How do I get EU GMP? Where are we? And so I think we should just jump in right top five reasons.
Dr. Jon 02:47
Let’s do it. So overview of the EU GMP. Let’s take a look at that. Start off with that slide. I have
Randall Thompson 02:53
that’s a good slide. I that’s a very informative slide. Wow.
Dr. Jon 02:58
Yes, those look don’t you like now the Nice Nice, nice. Look at that orange line. It looks so good.
Randall Thompson 03:05
Is that orange? Okay, I’m colorblind.
Dr. Jon 03:07
five reasons to be EU GMP. Number one. We’re going to go over some of the status of both hemp and cannabis because a lot of the reasons you might you might do EU GMP has a lot to do with what the status is of the current regulation, eu import certification and inspection. I’m going to be talking a little bit about that. And then EU GMP overview again,
Randall Thompson 03:31
it would be very difficult to read this slide five times really fast.
Dr. Jon 03:35
Why don’t you try
Randall Thompson 03:37
five reasons to be EU GMP and claimed EU hemp and cannabis status EU import certification, eu GMP overview,
Dr. Jon 03:43
ah one time good five times. Okay, so here’s the top five I was worried about doing. Does anybody have any? Any kind of doubt what the number one thing is? Obviously, it’s money.
Randall Thompson 03:55
It is money it should be four dollar signs and not three.
Dr. Jon 03:59
Oh, okay. Ah, access to the market with population of 500 million. Okay, populations 500 million. So if you you know, you got maybe five to 10% of the population that would
Randall Thompson 04:12
500 million is a lot of people
Dr. Jon 04:14
imbibing in cannabis. And so there’s a big market there. And of course, a lot of people are salivating over obtaining that market. There are market forces that right now as we speak, positioning themselves to have monopolistic tendencies within that market. And usually what they do is they partner with regulatory bodies just like the pharmaceutical companies normally do and they create very large barriers to entry. Okay, so what we’re talking about here with EU GMP is essentially a large barrier to entry mostly because the EU does not consider cannabis to be considered to be a narcotic or a more like, like the US had it as a school has it as a current schedule, while I.E. no medical benefit. That’s the same thing with the EU for cannabis. Now hemp is a little bit different, but I’ll kind of go in it depends on which country you’re talking about. Okay. Um, so a lot of people want to also take advantage of the growing EU market. In other words, it’s it’s going to grow, it’s starting out pretty small. So it’s, I would say it’s somewhere right around where the US was maybe 10 or 15 years ago. So you know that there’s going to be this huge upswing huge upswing, people want to get involved in that. And so there’s a lot of people making a lot of investments into EU GMP certifications, increasing the professionalism of your own company by implementing a pharmaceutical quality system now I would have to say here before I get into number three, um, you know, this really works for countries where it’s legal to export THC and it also would work for companies where a country’s where it’s legal to export CBD or hemp products. So if you’re in Canada, of course you could you have an export import export market for both of those items. If you’re in the US, obviously, you can’t export cannabis, because that’s a federally regulated thing. So but you can export hemp, of course. So that’s something you just need to think about. Um, number three, increased the professionalism that’s a if you are able as a company in hemp or cannabis to really create a pharmaceutical quality system you have made a lot of investment in money and dollars and infrastructure and people and it really does elevate the level of professionalism that you’re operating at no question about it.
Randall Thompson 06:38
Dr. Jon 06:39
The biggest advantage however, is differentiation. You brought this up when we were discussing it Well, you did well and it does make it makes a big it makes a big deal.
Randall Thompson 06:47
I must have had a good idea
Dr. Jon 06:48
if you have all of us EU GMP specifications and you can say hey, we’re EU GMP certified that just does give you a whole lot of gravitas
Randall Thompson 06:58
it does good word gravitas I like that and that’s like having that checkmark that your ISO certified yeah something like that. Yeah, I mean that’s that’s good. You need EU GMP is is good right having that as a checkoff huge differentiator
Dr. Jon 07:13
Just so you know, though EU GMP equals pharmaceutical quality system so you’re basically you are complying with the same rules that big pharma complies with like for example, but like Bayer or Eli Lilly or Pfizer or any of those other big companies so it’s a it is the view or a big hurdle? If the is the view worth the climb, you have to answer that question for yourself. Number five, consumer confidence in the quality product. You know, a lot of people they make, they make drugs, they they produce drugs, they put them out on the market and they’re well understood it from the standpoint of adverse events, they’re understood from the standpoint of side effects and things like that. And then also the quality usually the consistency of the products that are put out are very, very, very, very consistent, okay. In that that goes for natural products as well. Even though those will have have natural variability to them, you know, still yet like if you if you have ginkgo biloba, you’re gonna you’re it’s gonna vary in potency purity identity from
Randall Thompson 08:16
Korean red ginseng,
Dr. Jon 08:17
or, or Chaga mushroom.
Randall Thompson 08:20
I love chaga
Dr. Jon 08:21
Randall Thompson 08:21
Chaga chaga chaga chaga chaga.
Dr. Jon 08:24
So those are the top five reasons I mean, it is going to take your it’s going to take your company and the way it functions, the way it manufactures from, you know, kind of a lower level to a much higher level, no question about it. So I’m going to make you think about risk and risk assessments. We’re going to kind of go and
Randall Thompson 08:41
are you going to talk about the iterations leading up to EU GMP?
Dr. Jon 08:44
Yeah, crawl walk run you mean?
Randall Thompson 08:46
Dr. Jon 08:46
yeah, we can we should talk about that. It’s not in here but we should talk about that because no one’s gonna start off with that. No me hitting that usually they start off with you know, something small, do I So first, you know that that would be my recommendation
Randall Thompson 09:00
or even just GMP?
Dr. Jon 09:02
Yeah, or GMP but ISO you’ll get you know, if you do like ISO 22,000 that has an what they call a hasip which is hazardous control point, you know, analysis and controls Okay, that was that portion of ISO you’ll get certified to that by a third party and it’s it’s just it makes you you know, really operate at that level with GMP in the US You know, you’re not like ordering up a inspection correct right but it but it’s good that gives you kind of you kind of need that you
Randall Thompson 09:33
wouldn’t Manufacturing Practices GMP, right and so getting that the ISO I agree with you that GMP is a good starting point. So you’re focused on good manufacturing practices, and they’re different in domestically versus Canada versus other countries. Because then they’ve you’ve got g MP GPP. Yeah, biopharma right, GMP.
Dr. Jon 09:57
Yeah in the US that there are different parts. There’s 21 CFR Part 110 111. Okay, and so each of those different parts have a different, you know, a different focus. Okay, we’re part 111 here, we’re gonna do part 111, which is the nutraceutical you go, stuff, but there’s also cosmetics, there’s, there’s pharmaceutical, right there’s food, there’s food safety, there’s, there’s a bunch of different but there’s a, there’s a regulation,
Randall Thompson 10:22
there’s a huge push for this big hurdle that you have to overcome, which is EU GMP compliance, right. So if you’re exporting, you need this. So So pay attention because this is a big market. It’s trying to be controlled by the big guys. And if you get this now, some, some of that will be grandfathered, but you have to keep moving. That’s why the idea of going through the ISO process, yeah, huge, because that gives you put you in that audit mode. And that’s what you’re going to need.
Dr. Jon 10:49
Yeah, that’s why I say like, ISO ISO 22,000 is probably the good place to start. because that’ll get you that’ll get you thinking about, you know, it’ll get you a Kappa system, which is a, you know, control recall system, it’ll get you thinking about how to run down, you know, problems that occur, you know, looking at out of specifications results is going to put in place a quality assurance and currency quality control plan. Um, you know, what, a lot of people when they think about GMP, they usually think about like manufacturing, right? Yes. But really, it’s way more than that. It’s it’s kind of an all encompassing, you know, it starts with your personnel starts with your org chart, you know, making sure that you have people that with the right training in the right places to actually implement what’s required by the regulations.
Randall Thompson 11:37
And that’s ISO as well. So you’ve got to do that. And we’ve talked in other podcasts, where all of these tools that are available to you, including our IGW lab that allow you to automate some of these practices and quality assurances, and things so that you can train you can do everything with an integrated run company.
Dr. Jon 11:58
Yeah, so the GW, what it helps you do really is is centralize and make the data for the, you know, for an audit or something like that really easy, because you’re just running reports, and you’re showing, okay, here everything is in
Randall Thompson 12:14
but it has to be consistent. That’s, that’s the key. And even when we’re talking about EU GMP, you know, the last item you had there is that, you know, your clients have a confidence in doing business with you because you’ve been compliant to these specifications.
Dr. Jon 12:28
right. Yeah. So yeah, so um, one thing that’s interesting is with the EU is that you know, cannabis and CBD are really regulated as a narcotic. Okay, so I’m kind of weird even in it’s a little bit contradictory when it comes to CBD. Because in a lot of countries within the EU, CBD is, you know, either a novel food like it isn’t Great Britain, if for isolate only. And I’ll just kind of go over some of those things. But this slide right here just shows that this is the this is the health product regulatory authority. In you can see in here that this is the when they have their regulations that they publish for import, they’re really talking about here CBD as part of a controlled drug, as you can see the appear control drug, and then you have the word. And then you have the word CBD. Down here, right. So you can see that there are there significant departure between the members of the European Union countries, their local bodies, and the EU superstructure, which is making the regulation which makes it kind of confusing from a regulatory environment.
Randall Thompson 13:39
And I’m easily confused.
Dr. Jon 13:40
Yeah, well, I it It also is, yeah, it also for those who, you know, say Okay, look, where’s this gonna go? And they have the foresight to look at the market. They’re saying, Okay, well, probably the regulatory bodies are gonna win, and I might as well get in the paper right now. So a lot of people are making that calculation. So um, so that’s why many companies opt for a GMP registration as a pharmaceutical, and a lot of people asking, okay, well, so what are they actually registering for and if you look at the GMP certificates, you can go on to the medicines, European Medicines Agency, and they have a database there and the database you can look up anybody certificate really so if you type in just like Canada, and you look at all the certificates from Canada, you can see all of the regulations that they are complying with that they have been inspected to and what they’re really actually even selling. So like for example, one of the companies that’s in Canada that has a has a certificate is only selling flower and they’re only selling flower in Germany, okay, other other you know, types of certificates might also have in it manufacturing operations for active substances and like oils and extracts and things like that. So you can see most of the products that they are drawing the regulations down to our non sterile products, liquids for internal use. And then they have this other category, which is cannabis extract, and then packaging. So obviously, you have the non sterile products, plus you have the packaging, including liquids. And then so most of the companies that
Randall Thompson 15:21
I’m looking at this, I don’t go and that’s terrifying when you get to 1.5 point 1.17.
Dr. Jon 15:31
what about 1.2? Point 1.7 or 1.3? point one? Whatever? Yeah, it is, it is. Yeah, one seven that stuff. Other non sterile Medicinal Products, both packaging of dried cannabis flowers, including small quantities. Okay, so if you you know, this is kind of a compile ation, a lot of people also get certified for this quality control testing. In other words, you know, QC is a major part of GMP, any GMP program. And so a lot of people get that quality control, also inspect it, you know, if I have a certificate that says, hey, here’s my, I am now offering myself to be pre inspected, or inspected by an agency authority, or one through seven or 1.1 5.1117. And then also one, six, it there, it would open it up also to the laboratory operations.
Randall Thompson 16:22
Dr. Jon 16:23
Okay. And then also, there’s this three, which is manufacturing operations of active substances, 3.2 and 3.2. point one, which is the extraction of substance from the plant source, this stuff comes from the WHO, and also the WHO
Randall Thompson 16:37
Dr. Jon 16:37
the WHO. So it, you know, from that standpoint, World Health Organization, you get certified for that as well, from that, from that 3.2 point one, anybody who wants to take a look at section three of the manufacturing operations from, from the World Health Organization, actually, it’s quite, it’s a nice document it it has a tremendous amount of information in there, including information on solvent residuals, you should probably take a look at that. Well, and yeah, I mean, go read it and weep basically. Now, interestingly enough,
Randall Thompson 17:12
and then watch our podcast that tell you how to fix that. Exactly.
Dr. Jon 17:16
I mean, yeah, well, these guys are gonna go in, and they’re gonna take a look at your manufacturing operations, they’re gonna look at the lot numbers, they’re gonna look at the purity of every every, you know, every purity potency identity of every ingredient that touches the product, okay, and you’re gonna have to show that there’s no residuals out of there, you know. And so, you know, some people can do that. And there’s also this idea of risk associated with that. So I’ll kind of go into that in a couple steps here. But just suffice it to say that in these types of environments, like the EU, GMP, they’re under great scrutiny. So let’s just put it that way. So anyway, that’s what people are typically getting certified to, while they’re declaring, okay, I’m importing this material. And here’s what I’m declaring to the agency that I’m importing. And then they’re going to come and with your application, they’re going to either order a pre inspection, or you’re going to get inspected at some point.
Randall Thompson 18:10
And so when you’re looking at this, I see this subset, it’s the oppor, the whole manufacturing operations, the packaging, the product, yes, in the end,
Dr. Jon 18:22
and it’s way more than that. So I’ll show you, I’ll show you some other stuff. So it’s a lot before we get into that I wanted to try to kind of go in to what this regulation looks like from the hemp standpoint. So from the cannabis standpoint, in a lot of ways, it’s much more clear, okay, they think it’s a narcotic, fine, you might disagree with that. They think that it has never been used, and there’s no medicinal qualities to it. Okay, whatever. That’s why it’s a scheduled, you know, scheduled like kind of like the, you know, the federal government in the US are not like Controlled Substances Act, schedule one equals no medical benefit, which obviously, you know, has been pretty much proven by the scientific establishment. So the scientific establishment is contradicting the scientific istep and then now they’re fighting. Okay, okay. All right.
Randall Thompson 19:08
So that’s a house divided
Dr. Jon 19:10
a house divided. So that’s why it’s the tale of many cities, okay. Because what you’re talking about with the EU is the EU superstructure overall, a large conglomeration of countries that are independent, but not really independent, they have their own regulatory bodies, some of them are better than others. And some of them are more free than others, some have much more regulation, but they have higher populations more maybe more more lucrative markets for example. So what I have here is just a listing of of you know, kind of a I’m calling each of country like a different city and just look at the differences between the different locations so um, you know, from the EU standpoint and claims that hemp CBD has not been used in human consumption prior to night may 15 1997. That’s That’s because they are declaring it a novel food okay. by some of the writers So it wasn’t used prior, you know, widely used prior to 1997. I think that scientific establishment has pretty much agreed that that is the case that it wasn’t, you know, hemp was not used in a medicinal way prior to 1990.
Randall Thompson 20:13
So when I think it’s
Dr. Jon 20:14
really hard to believe, but okay, I’m just saying I’ll just, you know, it’s science, so it has got to be Right, right.
Randall Thompson 20:20
And what I think of as novel food would be like an ice cream sundae. No, that’s not what that does. That’s novel food. Right? That’s a brand it’s like a drumstick.
Dr. Jon 20:30
I think the novel food is is basically just a way to put normal stuff through a big taxing situation. So you have a way to tax that
Randall Thompson 20:38
you have. Okay, so a lot like the tale of many cities is the best of times and the worst of times,
Dr. Jon 20:45
right. That’s what we’re that’s what we’re talking about. Right
Randall Thompson 20:47
there. Wait, there’s more normal is a far far better place that I go. I have ever been, right? Yes. So we got the beginning of it.
Dr. Jon 20:55
I haven’t read that a long time A Tale of Two Cities. Okay. CBD outlawed by Germany in food supplements in 2019, unless they were authorized as a medicinal product or novel food. Okay. So they’ve actually sent in their authorities to seize people’s CBD. In some cases, um, many people just relabeled the products and the labor relabeled them as aromatic products instead instead and put them back out there. So there’s a lot of you know, because if you can have hemp or whatever, yeah, and I think, yeah, it could have been like they were violating regulatory labeling requirements, right. So we have those Italy’s proposed increasing the THC levels for hemp 2.3 right now they’re currently at point 2% right? If you’re in Italy, and allow biomass to be sold, you know smokable hemp, okay? hemp products and food is still not allowed. You can have any CBD for pets and CBD for animal feed is also not allowed. So while skipping down Spain considers CBD to be a novel food. So here we have the full gamut just in a couple of bullet points there the full gambit of here, Germany thinks that it’s a complete pharmaceutical, it’s going to be dominated by pharmaceutical companies or companies who pay the piper to get EU GMP. Spain is looking at it as a novel food item. And I’ll go through what’s required to really, you know, show it’s a lot of work to show that it’s a novel food, you might want to join the hemp Association in Europe because I think that they are putting in a novel food application anybody who signs in on that I think they’re trying to do some sort of conglomerate grandfathered in. So yeah,
Randall Thompson 22:31
in Germany up there it says that you it is outlawed unless they were authorized as a medicinal product or novel food
Dr. Jon 22:39
medicinal product is that is a pharmaceutical write a novel food is the novel food item.
Randall Thompson 22:44
Yeah, that was that novel food in Germany the same definition of a novel food in Spain?
Dr. Jon 22:48
I think so. I think so. I think so. Yeah. So there were people who were selling it with neither of those. Oh, and then that was not allowed.
Randall Thompson 22:56
Stupid, stupid, stupid. Sorry.
Dr. Jon 23:00
Sweden says CBD is our narcotic. I don’t think it’s that that cut and dry but it’s very similar to to Germany. I don’t think that what that means is I don’t think they accept the novel food I might actually be not complete on that. But I know that there is the summary of the regulation that I read. That’s kind of my Cliff note from it. Um, okay, Poland is regulating it like a food with a VAT. Those guys are smart. I had like, okay, you could do whatever you want. Just give us a lot of money. Okay. And 5% VAT is not so bad. I mean, some of the, if you look at the very bottom there, Belgium, Belgium says it’s okay to smoke
Randall Thompson 23:37
more literary. And God bless us, everyone.
Dr. Jon 23:40
And God bless us all. Everyone. Yes. Okay. In Belgium, you see at the very bottom, skipping to the bottom. It’s okay to smoke even him. Okay, as long as the 20%
Randall Thompson 23:54
that’s pretty awesome. Go Belgium.
Dr. Jon 23:56
Randall Thompson 23:56
Dr. Jon 23:57
Yes. Okay, so now it’s starting in
Randall Thompson 23:58
also good beer in Belgium. Belgian beer is good.
Dr. Jon 24:01
In Switzerland. 1% percentage is okay,
Randall Thompson 24:03
well, so 1% 1% is that a point? 1%? Or is that a point point point one
Dr. Jon 24:09
right. But the Netherlands look at here. It’s point Oh, 5%. So you got point. 2%. You got point? Oh, 5% and you got 1% which is a
Randall Thompson 24:15
Dr. Jon 24:16
A weird idea. Other Okay, the Netherlands. This is really funny. I can see. I hope that I hope that this has characfterized rise, right. Because as I was reading this, it was almost like he’s weird. So THC otherwise is there narcotic. Okay, so CBD isolate is illegal, but it can be exported. So you you can’t.
Randall Thompson 24:37
So it’s illegal, but you can exclude other people’s countries. Right. Not internal. Right? That’s right.
Dr. Jon 24:43
Yes. So in the UK isolates allowed and that’s not that’s also under the novel.
Randall Thompson 24:48
Dr. Jon 24:48
Randall Thompson 24:49
yeah. Gotta do something with those windmills.
Dr. Jon 24:52
Randall Thompson 24:53
Dr. Jon 24:53
Well, you got to feed those tulips, you know, they gotta be happy. Okay,
Randall Thompson 24:58
tulips is big business. Oh, to dream, the impossible dream to fight the unbeatable foe.
Dr. Jon 25:10
Okay, we’re moving on.
Randall Thompson 25:11
Okay, Iceland UK? Total poll question. How many of you want karaoke night? Right after the scotch and bourbon tasting?
Dr. Jon 25:22
Okay, all right, tell us tell us tell us. Bulgaria CBD is allowed in the food and then Belgium, it’s in the smoke. So the point here is pretty obvious is that I think they’re just in the process of trying to figure out what the regulations are. The countries are trying to put in their own regulations. And then the superstructure is just like, Oh, yeah, THC is evil. I just got tired of reading it. I didn’t want to be Yeah. So anyway, here’s the here’s the novel food application requirement. Okay,
Randall Thompson 25:54
Eskimo pies. Let’s go.
Dr. Jon 25:55
And let me see here required data for novel full of novel food application, full toxicology assessment, and you can see that that, um,
Randall Thompson 26:03
you know, we’re getting hungry for a Dilly bar,
Dr. Jon 26:05
a CBD dilly bar,
Randall Thompson 26:06
just any Dilly bar at the moment. Sorry, all this talk of novel food. Sorry, I
Dr. Jon 26:12
didn’t mean to build the assessment, product manufacturing data for a minimum of five batches. So there’s a lot of work there to do.
Randall Thompson 26:19
And that’s how long it takes to get that recording. Right. That’s how many how much
Dr. Jon 26:24
toxicology studies. You know, a lot of these things have been already, you know, they’ve been what they’ve been published on. And they have been, you know, so the data is available. The question is, do you have to have that data as a as a first party assessment? I think you do. Your there has to be your data. So
Randall Thompson 26:41
it’s not Oregon.
Dr. Jon 26:42
It’s not self not self certifying? No.
Randall Thompson 26:46
Shoot, what is genome toxicology idea? Because I have no idea. Okay.
Dr. Jon 26:51
It says Ames testing. Oh, that must be That must be it. That’s an IQ test is from Iowa, what it is aimed to No, no, no, no, no. This I I don’t remember what Ames themes test is I think they
Randall Thompson 27:04
build the first computer ever. It’s a genetics test. Okay, I’ll go with that.
Dr. Jon 27:08
Um, let’s see here. And then detailed information on typical CBD exposure and usage. So a lot of that stuff is, you know, available, like the World Health Organization has a pretty good compendium of data, you know, toxicology data,
Randall Thompson 27:21
I refrained from
Dr. Jon 27:23
Yes, the who. And then the risk assessment. They also have a risk assessment and risk mitigation. So anyway, this is what if you wanted to do that, but you know, actually put in an application, this is what you’d be required to do in this case. That’s why it makes sense to have like, consortium do it. And I don’t really, you know, because it’s, it’s basically it’s the same for most all the foods, I guess, if you have a CBD gummy bear, though, it could possibly be different than, say, a CBD tincture. So you may have to do like multiple different products or novel food. I think that’s how that works. But a lot of work actually to get in.
Randall Thompson 27:56
This is not an iterative process. So you don’t start at the bottom and the two or three weak items and build up. And then by the time you get to the eight or nine months, you’ve got it all this is not that. I mean, you really have to start big, and then you have these other tag on things,
Dr. Jon 28:10
and it’s going to cost you a lot of money. Yeah.
Randall Thompson 28:12
So okay. Yeah, yeah.
Dr. Jon 28:14
And some people have gotten through this already. And so, you know, they have either they’ve scraped data out from the, you know, from the literature, and they’ve put it together, and you can hire people to help you through this. And you definitely need to do that, because it’s a lot of work. Okay. Um, here’s some recent news, I guess, we have this, the Czech Republic is is basically has a, this company here has a valid a valid designation, so they’re going to have to go now into risk assessment. So there’s a whole bunch of companies that are going forward trying to get this novel food designation and for good reason, right?
Randall Thompson 28:51
Yeah, you bet.
Dr. Jon 28:52
Um, so now I’m going to talk a little bit about regulations for EU GMP. Suppose you decide that you’re going to bite the bullet and you want to go ahead,
Randall Thompson 29:01
let’s go. I’m ready. I’m ready.
Dr. Jon 29:02
Yeah, I’m ready. I got my big checkbook. Okay, we’re gonna go do it. So these are the main directives that you need to be looking at the 2003 94 ec, there’s active substances. This is this article 47 really is about a eu European Medicines Agency, you have to provide detailed guidelines to people who are going to comply with this 2003 94 etc. This is very similar they directive 203. That’d be it would be like in the US every 21 Code of Federal Regulations part something similar, similar set, and then these right here, the Q seven and the Q nine are really the two guidelines that I just mentioned. Okay. So those are published by the IC H. And there’s also this EU GMP guide Part One, two and three. They’re really good. So if you are looking at providing getting a step by step, okay, here’s the Here’s the requirement one requirement two requirements three for each one of the categories that are in GMP and risk assessment. Your your EU GMP guides are really great, your Q seven and Q nine are gonna be really great. You got to read them, you got to download them, you got to start looking at them. And then you could ask yourself, is the view worth the climb? You know,
Randall Thompson 30:16
is this something that we can put together as a downloadable form with links
Dr. Jon 30:20
there? Yeah, we can put links in there. No problem. In fact, I
Randall Thompson 30:25
have with with that link. Yeah, I
Dr. Jon 30:26
think so. I mean, this will be on there the links, we can put some links together, maybe just in a page. And we can put links to Yeah, cuz they’re all powerful.
Randall Thompson 30:34
And you make a note to do that.
Dr. Jon 30:36
They’re all public right.
Randall Thompson 30:38
Yeah, well, they are but it but for for you guys who are watching this, there’s obviously an interest and I think it would be helpful just to have this as a with the link so that we can put it on our site and have it readily accessible,
Dr. Jon 30:49
right? Um, yeah, no problem. So then also, no surprise here. Depending on where you get your certificate, there’s also the the country in which your company is located, there’s going to be a, a country based regulation as well. And a lot of the certificates that I have seen are based in Germany. And so there’s inevitably you see this citation section 72, a, a one sentence, one number paragraph to the AMG, okay, so that’s something that each things, each country appears to have its own CBD hemp regulation. So there are some good articles that try to, you know, basically summarize it all, but they’re changing quite a bit. So stuff that you might have seen, you know, back in 2018, or whatever, it’s probably not the same as it is today. So you probably think that I think about that. And then there’s this novel food regulation that you need to know about if you’re going to do CBD. And then there’s implementing regulations for third party or third country, we would be a third country by importing into the EU. Yeah, so that that’s the those are the regulations. And I, within each of these regulations, it kind of it’s just like a whole bunch of other regulations that feeds into right. So make sense, right? So one regulation will refer to 100 other regulations. So just think about that.
Randall Thompson 32:14
And it’s hard to refer to us as a third country in an election year.
Dr. Jon 32:19
But that’s what they call us. We’re a third country we get if that’s what the calls we got to wear,
Randall Thompson 32:23
that’s got to wear, like a third party, but we’re a third country.
Dr. Jon 32:26
Yeah, that’s right. So there’s that interesting. Okay, so suppose you wanted you also have these slides in certification, right? Yes. So, okay, so there’s a couple different ways to do that. There’s this HPRA, which is the health products regulatory authority, okay, so once you put in an application, they you can actually get to the point and do the right, you know, make the right checkmarks that they will order a pre approval inspection for you, which is pretty sweet. But you have to have all of the information on in the US if you’re from a US company, they recognize the FDA, but you have to have the FDA establishment identifier number that’s the FBI number that that has to go on that meeting you have already been inspected by the FDA and you get first sale and you know, well not you know, it’s a it’s a paperwork exercise, but you still have to have that. So start with for those of you who are not a huge, if not US FDA certified yet under a particular part. You should probably do that first. So I do ISO then I do FBA, GMP, and then I do EU GMP, but that would be my crawl, walk one run strategy,
Randall Thompson 33:36
and that’s what this reminds me of like the beanstalk climbing the beach. Yes. Because you’re climbing jack jack and Okay, the climbing at the top, he
Dr. Jon 33:48
finds the giant
Randall Thompson 33:48
Well, the reason I say that is because we’ve got all these acronyms. It’s … this is your path to EU GMP certification.
Dr. Jon 33:59
Yeah, I know. See, I told you we had acronyms.
Randall Thompson 34:03
And I bring up the anachronism. Okay.
Dr. Jon 34:06
So products are produced with a quality required for intended use. So that’s really what they’re after. Right? That they want to make sure that the products are what they say they are, that they’re pure according to the quality requirements that you have established for that in in accordance with your risk assessment, and that you’re manufacturing them in accordance with GMP principles applies to importers, also distributors and also wholesalers. So they have to provide like a recall system and things like that. And manufacturers of human Medicinal Products, so the word human Medicinal Products, those three words, okay, those are the words that you saw on the previous slide. That’s human Medicinal Products. That’s really that’s the that’s that’s the only Yeah, you’re talking about drugs, man.
Randall Thompson 34:52
This id medicinal products
Dr. Jon 34:54
Applicability to cannabis. And just keeping in mind that hemp and CBD are distinct from cannabis in the us but are still considered control substances in EU and Canada. I mean, in 2018 2019 we had the hemp farm hemp bill, which De-scheduled CBD.
Randall Thompson 35:12
Dr. Jon 35:13
It was groundbreaking crazy. And interestingly enough it De-scheduled THC to .3%
Randall Thompson 35:19
Dr. Jon 35:20
Yeah. So, uh, that’s amazing that that that really took case law and all kinds of things and just, you know, many, many, many years of the drug wars and all of that and it really kind of just like, okay, the schedule, that’s okay. Wow. Yeah. I mean, that is groundbreaking. That is I mean, yeah, that’s a it’s like a, you know, like, prohibition ending?
Randall Thompson 35:44
I know right. Did you know that there were more when you do the research, there were more people ill during Prohibition than any other time in the United States?
Dr. Jon 35:55
They were probably getting ill from the moonshine.
Randall Thompson 35:58
Well, okay, just as
Dr. Jon 35:59
have you tasted moonshine
Randall Thompson 36:01
Dr. Jon 36:01
Randall Thompson 36:01
Dr. Jon 36:02
Randall Thompson 36:02
Dr. Jon 36:03
Randall Thompson 36:04
But, but wasn’t that good? Yeah, that’s bad. But what happened is the reason they that research comes up is because they had more prescriptions written during Prohibition than any other time in the United States history.
Dr. Jon 36:17
Randall Thompson 36:18
Yeah. And and the certificates if you do the tours, were for bourbon
Dr. Jon 36:22
Randall Thompson 36:24
The prescriptions were for bourbon.
Dr. Jon 36:25
Randall Thompson 36:26
Dr. Jon 36:27
Well, I think that I mean, make sense. Like if you are addicted to like tobacco you have a pat right. Yeah,
Randall Thompson 36:36
sort of they have like a burger bourbon bet. That’s interesting.
Dr. Jon 36:40
Some people get addicted to bourbon. I’m
Randall Thompson 36:42
sure. I’m sure. But not I like I prefer bourbon.
Dr. Jon 36:46
Well, I haven’t had a drink since breakfast. So I don’t have a problem. What? Okay, a hemp and CBD are distinct. Okay. still considered a controlled substance in the EU in in Canada? Um, yeah. The the hemp laws are not liberalized in Canada, in the UAE the way that you know,
Randall Thompson 37:06
most people think we drink before the show.
Dr. Jon 37:12
No, this is actually how we are.
Randall Thompson 37:14
Dr. Jon 37:14
Okay. hpra has received many applications for him growing with and they noted that in their 2019 report, which is that that’s the health products regulatory authority. They are located in Ireland. Oh, in Dublin.
Randall Thompson 37:30
Dr. Jon 37:30
Randall Thompson 37:30
So you know, if if you switched the letters, you know, it would be harpin that makes more sense to be from Ireland.
Dr. Jon 37:39
That that was actually really good. Like that. Okay, so that’s the certification part of it. It’s it’s complicated process, you’re gonna need help.
Randall Thompson 37:50
So it’ll take like a week.
Dr. Jon 37:52
Yeah. Just go in and start reading and you’re gonna be like, Oh, man, I need I need to get some help. So if you do get some help there just gonna give you a you know, they’re going to give you Okay, they’re first of all going to look at are you even close to being ready, okay. And like I say, get the crawl, walk run strategy here totally is, you know, ISO, GMP, US FDA and the EU GMP. So EU GMP post certification, inspection and coordination. That is now that you have your certification now that you have your wonderful, you’re wonderful
Randall Thompson 38:28
root canal and an enema at the same time.
Dr. Jon 38:31
That’s what that is. Yes.
Randall Thompson 38:34
Dr. Jon 38:35
Exactly what that is
Randall Thompson 38:36
I apologize for that imagery. But that’s all I could think of that couldn’t contain.
Dr. Jon 38:42
No, no, I think you nailed it right on the head. So the national competent authority, okay, and the that’s coordinated by the AMA is going to ECU into noncompliance. And then they’re gonna revoke your GD GM dp certificate and their database.
Randall Thompson 39:01
I think we need to start drinking. If you’re thinking about this, you can join us.
Dr. Jon 39:06
Oh, okay. Yeah, the inspection, it basically follows a regulation. That’s what our 111 four directive, that’s the directive that you need to be compliant with and usually the non national competent authority will do that. Um, and then the e. m, a will kind of coordinate everything now.
Randall Thompson 39:25
The European Medicines agent,
Dr. Jon 39:27
that’s correct. Yeah. Now, I had read on the HP office are a the agency. Yeah, that I just talked about in Ireland, the Harper organization. I think that they do inspections this too. So and because it says in there that they do inspections, but for pharmaceuticals that appears to me, given the given the regulation that they’re only looking at those inspections in Ireland, otherwise it is conducted by the National competent authority in The country that you are in
Randall Thompson 40:01
and earlier you talked about the German Medicines Agency.
Dr. Jon 40:04
Right. So that was the German people coming in
Randall Thompson 40:07
which would take priority in Germany, right. Depending on if you’re a federalist, right. Or a nationalist. Yes. Right.
Dr. Jon 40:15
Well, yeah, I think that it you Yeah. If you had if your company was incorporated in Germany
Randall Thompson 40:24
GMDP. Yeah, that is manufacturing data practices. Is that what
Dr. Jon 40:32
yeah, that’s the I don’t know what the GMDP is. I don’t know what the DP is. It’s just type in gmpp database and you can go in there and you can look at you can look at everybody who certificate dies.
Randall Thompson 40:42
I was all excited. I thought, I thought I might have gotten a guest right?
Dr. Jon 40:45
Randall Thompson 40:46
so totally shut down.
Dr. Jon 40:48
Randall Thompson 40:50
Dr. Jon 40:52
Randall Thompson 40:53
Like I said, Oh, GAMP is good. Automated manufacturing practice.
Dr. Jon 40:58
There’s, there’s 12345
Randall Thompson 40:59
Dr. Jon 41:00
Yeah, there’s there’s different Oh my god. So this is the basic requirements for medicinal product.
Randall Thompson 41:04
Are we covering all of these today? It because we got we got nine chapters to go. Oh, yeah.
Dr. Jon 41:29
You know what? This is a German, German death metal band. Oh, yeah. How very appropriate. Okay. basic requirements for Medicinal Products,
Randall Thompson 41:45
basic requirements, nine chapters
Dr. Jon 41:47
of a pharmaceutical quality system. That’s the number one, I’m not going to go over all the rest of these. But just suffice it to say that these are single premise equipment documentation. outsourced activities. Okay. What is a pharmaceutical quality system? A lot of people ask that, really, it involves GMP, which is the good manufacturing practices, quality control, a review of those quality controls and product quality. And then risk management, you have to have all of these and it ensures that products are produced with the quality required in it, is it you know, a lot of people like oh, well, I don’t want to I don’t want to include in my GMP, or my quality system design and development and all that. No, it’s actually it is required that you have that
Randall Thompson 41:48
you have to do that. And that’s why when we build equipment for people who need specifications for GMP, or EU GMP, or beyond or GPP, right, we need user required specifications, specifications, or you are Ss exactly, because we don’t know which country you’re referring to, or you’re exporting to, because that’s going to dictate what you need.
Dr. Jon 42:55
Randall Thompson 42:55
Dr. Jon 42:56
Right. That’s it. So user requirement specification is basically taking all of the regulations that are in the country, putting them all in a spreadsheet and saying, hey, you have to comply with this
Randall Thompson 43:06
And when you go to quality control, is that when we’re talking about IQ, OQ?,
Dr. Jon 43:10
yeah, no quality control is usually I have a product and I need to make sure that it meets specifications.
Randall Thompson 43:16
Dr. Jon 43:17
And so I’m measuring the product versus the specifications got, I think quality assurance says, yes, you made it or No, you did not
Randall Thompson 43:23
check or none.
Dr. Jon 43:24
Yeah. All right. So I’m going to move on here go key elements to GMP s. And you have audit people plant and equipment, shelf life and distribution controls, quality control Kappa, which is basically your deviations or Oh, s out of specifications, results, defects, investigated root cause these are things that you have to have a recall system, a complaint system, traceability system qualification validation system, in sops, and processes to do that change approval process, documentation of all kinds of voluntary, everything’s got to be documented and continuous improvement. So these are the key elements. And then just imagine in your mind’s eye, like, you know, hundred points on each one of those bullets.
Randall Thompson 44:04
Yeah, the root canal audit is really and you got to
Dr. Jon 44:07
get through had to have a table as I was kind of, so I’m not going to go over this. Obviously, it’s kind of an eye chart. Okay. But, you know, again,
Randall Thompson 44:15
this is brilliant.
Dr. Jon 44:16
Yeah. Personnel training. Okay. job descriptions, org chart facilities, really,
Randall Thompson 44:21
except for the misspellings.
Dr. Jon 44:24
Look at this. Avoid, avoid cross contamination.
Randall Thompson 44:30
Dr. Jon 44:30
Isn’t it? Great. Yeah. So anyway, just just kind of a summary
Randall Thompson 44:34
of what we talked about. That would be really good.
Dr. Jon 44:37
Another thing is what is a qualified person? Hi. Oh, wow.
Randall Thompson 44:40
It’s not for me. That’s my I didn’t do it. And I did. Oh, eight, virtual high five. All right, good, good. Good. Okay. So
Dr. Jon 44:47
what is a qualified person? You have that’s basically if you’re going to release a batch for import or you’re going to release a batch. It has must be qualified person that that’s it must be someone who’s highly qualified. They actually have specifications
Randall Thompson 45:00
Dr. Jon 45:01
Yeah, yeah, it’s it’s pretty great. In fact, they’re taking liability for the release.
Randall Thompson 45:06
Should I be offended by this?
Dr. Jon 45:08
No, I You are not a qualified person.
Randall Thompson 45:10
Dr. Jon 45:11
So important batches to be retested. What’s great about qualified persons is if you have qualified persons making the regulations for other qualified persons they write themselves in as being indispensable as qualified persons. Yeah, it worked out really well. That’s like so that’s that’s essentially the sum total of GMP regulation I am Oregon. You know what? I respect that. Oregon, okay, we’re gonna self certify, Okay, there you go. Okay, it is one of you said, Okay. All right. Risk Management. thing, oh, let’s
Randall Thompson 45:43
go, this is fun. Okay, this is their cheese at the end of this now.
Dr. Jon 45:48
I’m gonna very warm very top level, okay, this is the ek, you have gmps on one side, and you have the risk management, the risk management really assesses your whole entire organization to say, Okay, well, process a is really important and critical. Yeah, along with piece of equipment, and therefore I need to control it, okay. Okay, and here’s what I’m going to do to control it. And then by the way, I’m going to try to put in processes so that I never have a risk of that ever going bad at all. And I’ll put some sort of process in there to make sure that there’s a risk. So a lot of it has to do with identifying ahead of the ahead of time, what could go wrong, and then pre, preemptively coming up with things to avoid and mistake proof your process. So IGW is kind of a nice, nice, nice part of that. But it really is, because what it does is it it mistake proofs your operation, in a lot of ways by putting, you know, it actually puts handcuffs on the way that you are manufacturing and puts it into a set process. And if they’re using it, they really can’t get out of it.
Randall Thompson 46:50
And IGW lab is really a manufacturing execution system. That’s right, that will integrate and it has some elements of lims, right a laboratory that
Dr. Jon 46:59
has laboratory informations. Okay, so just imagine that you have your all your quality documentation in one spot, along with controls and training records, all in one spot training in all your calibrations and all your expiration dates and all that stuff all in one spot along with all your batch records. And then all of your ingredients excipients information going in there along with all the washed traceable, lost lot numbers, and in addition to that, all of the, you know, all of the quality control data that goes and feeds into that if you have that in entire system, it’s not 100% even if you did that you would not be EU GMP
Randall Thompson 47:32
No, but you would it gives you a structure to do that
Dr. Jon 47:35
yeah it would be a structure.
Randall Thompson 47:36
And that coupled with the ERP and accounting and all of those are good foundations to build to this, what I like about the IGW lab and the way it was designed, is it it can you can build in these process.
Dr. Jon 47:49
Randall Thompson 47:50
And I love that.
Dr. Jon 47:51
Yeah, and upload stuff. So anyway, this is what you know, if you are at the point where you are going to do any kind of quality system, you really should bite the bullet and do your risk analysis. And there are a whole bunch of tools for that. I’m not going to go over them just just just really really briefly here um, this is haislip. I already mentioned that this is an FMEA or this is an ECA Mika, Mika, yeah, that this is a failure mode and effects and criticality analysis. Okay, wow, fault tree analysis. These basically are finding what what the root causes of a problem, okay, risk ranking, here’s all your risk, you rank them from top to bottom,
Randall Thompson 48:33
I think I’m stuck in FTA
Dr. Jon 48:33
Hey, it’ hesap is is identifying specific points where there needs to be controls within the process and making sure that those are the right measurements are set up to so that you can say, Hey, this is this is actually, you know, it’s a control part of it. And then FMEA along with the criticality, this C in there is basically identifying which ones are critical in making sure that you can actually measure that criticality. Okay, so these are all tools, they’re very well known. And usually what you do is you start off with an information and material flow, I always start there anyway, sure, no matter what you do, you have to have that first put, put all your information, your cycle times in there, all of your, all of your, you know where your inventory is, where your information is, if you can have a very good idea as to where everything all your information, material flow is you can then use this document by this document 60 8012 that really talks about these tools, and it’ll step you through along with forms and everything through the process of risk analysis.
Randall Thompson 48:34
Dr. Jon 48:34
So it’s, it’s pretty nice.
Randall Thompson 48:36
That is nice.
Dr. Jon 48:41
Um, I’m not going to go over this just suffice it to say
Randall Thompson 48:56
it’s a very bright slide
Dr. Jon 49:43
preventative actions and Process Designer typically used to prevent risk, okay, and you identify failure modes, okay, stuff like that. So I’m gonna move on here. Well, risk ranking and filtering is another tool that we have, and that is essentially here’s all here’s all your risks. Then here’s a if it’s relevant, here’s where you are ranking them. And then here’s your evaluation. And here’s your explanations. And here’s how you’re mitigating. Okay, so this is an exact way in which you would do a hazard risk analysis.
Randall Thompson 50:12
Dr. Jon 50:13
So, um, you know, and usually this would be maybe 2030 pages long. Okay. So for the equipment that we make, for example, we manufacture we do a hazard risk analysis on and we have all the risks, and we have them all identified, we have, we’re looking at the different compliancy rules and then we are saying okay, this is falls under sound engineering practice, this falls under like a PED requirement or this falls under an ASM a requirement or whatever. So
Randall Thompson 50:40
it falls under exothermal. reaction.
Dr. Jon 50:42
Yes. And things like that. Yeah.
Randall Thompson 50:44
No, no, this structure and format, you mentioned, the IEC 60218 number in the previous slide, is that can you find that structure in that document?
Dr. Jon 50:55
Um, no, but it will tell you, once you do the tools, you can then make a summary summary document? Yeah. So we make our own summary documents, okay. Also, you want to have what’s called a user requirement specification, okay, or urs, that’s basically writing down all the requirements for each of the items. So facilities, you’d have requirements document for and you have a risk assessment for facilities, you’d have one for personnel, you’d have a requirements document for equipment, for example. So that’s where we can come in and help you with the facilities, the risk assessment on those facilities, the risk assessment with your equipment and the actual or user requirements, specifications for your equipment. And every all of the regulations that would go into that drought, you know, like some people need, like material certifications, for example. Those are something that we have we have material certifications as well. Yeah. So we can help you out with that.
Randall Thompson 51:48
Or if there’s risk examination by and it says me.
Dr. Jon 51:57
Okay, yeah, usually you categorize risks as high, medium, and low. Oh, so there’s ms for medium
Randall Thompson 52:03
for him. Me and
Dr. Jon 52:06
Me and you.
Randall Thompson 52:08
Okay, oh, this is a good one.
Dr. Jon 52:09
Okay, so here we’ve come full circle. Now here are the top reasons against EU GMP and
Randall Thompson 52:15
why why would you never in the million years want to do EU GMP, and
Dr. Jon 52:18
please listen to this. Okay. So is the view worth the climb? Right? You always have to ask is, is there a statue in the marble is, okay? The cost barrier is high, you’re going to have to crawl walk, run your way into it, okay? So it has to be something where you know that you have the stamina and the commitment to actually going through all with the whole thing because it’s going to cost you a lot of money on market regulations for hemp is undergoing evolution, that’s the second one. In other words, it’s evolving and these really know what’s gonna Well, it’s evolving, it may it may devolve to into less of a regulation so you don’t really know where it’s going to go on the
Randall Thompson 52:28
like the Farm Bill act
Dr. Jon 52:59
kind of like that.
Randall Thompson 53:00
Dr. Jon 53:00
and then I need a high functioning personnel.
Randall Thompson 53:02
Okay, I’m out I am not high functioning
Dr. Jon 53:06
easier ways to make money.
Randall Thompson 53:09
Oh, I’m all about that. Oh, yeah, I’m back.
Dr. Jon 53:11
Okay, okay. Well, it is but at the same time the reward is is is quite good on the manufacturing side. I If it were up to me, I definitely would go for the EU GMP. I’m not doing any imports into Europe right now. No right plan to at the moment, but um, you know, but if I was going to do that, and that was a part of my strategy to you know, expand internationally, I definitely would do it. I’d bite the bullet I’d pay the piper, I’d go get it done. And it because then that would allow me to to really look at those other doc you know those other
Randall Thompson 53:46
and there are some really good people out there who can help you get there. Yeah. So find out you know who they are and work with them.
Dr. Jon 53:52
Right? Um, yeah, so a lot of it has to do with Okay, you want to want to purchase a good, you know, employee that has some background like a lot of background in FDA regulatory environment. Okay. Go look for someone from Gilead or something from someone from a Pfizer or someone you can find these people. Sometimes they a lot of times what they do is they pop out of the pharmaceutical organizations and they start consultancy. So that’s a lot because people don’t want to hang on.
Randall Thompson 54:22
I looked for the balm of Gilead.
Dr. Jon 54:24
Yes, yes. Okay, well, you could do that as well if you were so desirous. So, okay, number number number five there is enabling the idea that the cannabis hemp is a controlled drug. Okay. I just kind of bristle against it actually. Because I’m like, Okay, well, yeah,
Randall Thompson 54:40
I have no idea.
Dr. Jon 54:40
Well, it you know, like saying that CBD is a controlled drug or a scheduled scheduled narcotic. It just seems so ridiculous. But that’s just me, you know, whatever. I’m sure that’s an unscientific statement. There’s no science there. You know, but I just don’t believe that hemp is is going to kill people. And I don’t believe that it’s it doesn’t have any medical benefit. So that’s just me. And then about to the pharmaceutical regulatory complex, this is basically paying the Piper. You have to you have to get it. So a lot of it’s similar to the cost is barriers high. There definitely is that regulatory complex in the pharmaceutical companies they have, they have a great lobby, they have, you know, basically the regulators are living inside of their facilities, they have a lot of influence over that regulatory process. And so they have a distinct systemic advantage of when we’re really doing, you know, new applications and new drugs.
Randall Thompson 55:37
So as an as an entrepreneurial company, when I look at that final bullet, that just means selling out selling
Dr. Jon 55:46
and hoping to be one of those guys. Yes, I want to be, you know, nothing wrong with that. No, but they’re making the dough right
Randall Thompson 55:53
again. You know, is is the view worth the climb? Yeah. I mean, I like the way you say that, because you you have to make the decision on whether or not it is worth that investment of time and money.
Dr. Jon 56:04
Start with ISO 20.
Randall Thompson 56:05
And there is saying right now there is significant benefit to doing.
Dr. Jon 56:09
Yeah, yeah, I think that. Yeah. So if you’re interested in the 500 million, you know, people in that market. Yeah, it’s great. So there’s definitely a and and also the growth potential. Yes. So there’s definitely it’s definitely worth the million or so dollars that you’re going to put into it.
Randall Thompson 56:25
And it’s, but it’s a decision. Yeah. It’s a decision that you make. This was awesome. All right. I appreciate you going through this. And we covered a lot today. Thank you for your patience with us. This was really good. And I really only saw one table there were there were quite some slides that were quite full.
Dr. Jon 56:44
Yeah. But tables are not for anybody.
Randall Thompson 56:47
You’re an animal. I mean, that was really good. Yeah, that was a good summary of what to do and what not to do for getting into EU GMP. We talked about the European Medicines, agency, GMP, good manufacturing practices, GMP, risk analysis, novel food,
Dr. Jon 57:03
novel foods. Yeah. Now the only bars
Randall Thompson 57:05
IQOQ. We talked about urs we talked about IQ IQ. We talked about GAMP and GM dp, and how to get certified and where to find people to get help you get certified and kind of the path. And we’re going to have a download form with some links out there for you just to get start your research, because it’s exhaustive. There’s a lot here. Yeah. So thank you for being here. We appreciate that. And I am I wanted to let you know that we are here. We’re looking forward to talking to you next week as well. But and we’re going to be here the whole team is going to be here answering questions. If you still got more questions. There’s a lot of questions they’re feeling and set up a CBD jam sessions. We can talk through all of those right, we’ll be available again. Congratulations to Ignacio from Stockton
Dr. Jon 57:56
Randall Thompson 57:57
Cheetos Daddy, that’s right. Check out our live tours CBD jam sessions are extraction guides or distillation guides the calculators extraktlab.com/calculators mini courses. Thank you for being here. Always ask questions. We’d love them. Subscribe to our YouTube channel. Subscribe to our podcast. Yeah, these are also put together as a podcast. All we’ve got lots of things. Join us on our conversations on your favorite social channels, LinkedIn, Facebook, Instagram, Twitter, we’re everywhere. And you can register for next week at extraktLAB.com/set-dash list. So we just appreciate you going through the top five reasons to be EU and GMP. And the top reasons against being EU GMP
Dr. Jon 58:38
sounded like almost he did that so well. It sounded like one of those disclaimers. Yep. All right. All right.
Randall Thompson 58:47
You all heard thank you very much to go off. So well done, right? Yeah. Good job. All right.
Dr. Jon 58:52
Randall Thompson 58:53
Ask questions. soon. See you next week, the bye.
CBD Jam Session 58:56
Are you stuck in your hemp or cannabis business? Are you not reaching your processing goals? Here at extraktLAB, we offer a free 20 minute CBD jam session. A CBD jam session is a conversation with an industry expert, not a sales call. A conversation where you can talk to us about whatever issues you’re having right now and where you’re stuck. We will help you uncover any issues you are currently having in your business, create a solution to fit your current scale, develop a future scale up plan based on your needs and help you make your processing goals a reality. All while getting your business plan back on track. schedule your FREE 20 minute CBD jam session at 1-651-600-0036. Again, that number is 1-651-600-0036
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