DEA to move to Reschedule Cannabis Associated Press Reports

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Easy way to figure out a if a company is real cGMP is ask for the master drug file, ask about the robustness of the QMS if they don’t have either, or the QMS and MDF is weak then they are probably not going to pass an audit.

Bonus nachos; Ask for IQ/OQ/PQ, and OV/PV for each piece of equipment utilized in critical process. Ask to see the URS’s/ CRS’s for each piece of kit as well, if they can’t present these then none of their equipment is compliant or validated and they cannot produce and sell product legally with unvalidated processes/equipment.

The stuff mentioned above is just scratching the surface,
The amount of documentation required will make your eyes water, and even if a cannabis company is “cGMP” or built to “cGMP standards/CFR compliant” they havent passed an audit because no official audits have been offered.

Most companies aren’t going to make it simple as; the few that have been built/managed properly and are at a general level of compliance stand a chance of success, but still (and this will ultimately depend on how legacy facilities will be grandfathered in) its going to take months of work to validate processes and tons of documentation before companies can legally sell product which will burn money. Not to mention the potential need for stability studies.

Hopefully it won’t be this strict and legacy companies can continue to produce and sell materials, it’s too early to say how bad this is going to be, but the potential is there for this to be very very bad to like 95% of the industry.

My 2c

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Or just ask about their tech traceability documentation and how they went about implementing the practice. Having worked in one of the longest running food safety labs in the US, it’s a joke to see cannabis documentation, in testing labs or manufacturing. One testing lab I worked for literally just had functionally a blank form with a few media batch tracking slots in the top, and expected their techs to record their data however they felt worked best for them! Red flag, aye?

I think that, ultimately, there’s too much money on the side of incumbent cannabis business for the feds to simply give an entire industry to pharma. Like, that couldn’t be a remote possibility. Imagine the shitstorm all the C-class (corporate) cannabis folks would raise.

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I don’t like how they define the term “cannabis” in the language of the caoa

To me it sounds emotional like reparations instead of sound and science based legislation

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So much this! How many times have I been to a “GMP” facility that doesn’t even have the most basic commissioning document for their utilities and equipment?

But still years away. At least another 9 months before public comment closes. Then more time for other agencies to make changes - another year or two. Plus whatever time for the courts to do their thing (people are already gearing up to sue, not sure they have standing…but it will slow things down).

Plus who knows what congress will do between now and then? Close the hemp loopholes? Decide to deschedule cannabis or make a whole new botanical classification (like they did in the EU?)

Anything is possible. The least of the worry it getting to GMP - anyone who actually wants to do so AND is willing to invest in doing it will have time.

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I wonder if theyll give it enough attention to make a new CFR chapter. 211 is a bit hardcore for cannabis at the consumer level. API is a different story, and since you can sell API grade at a price that warrants the level of quality management it makes sense.

I see people on here operating under cosmetics and foods more than 211 drug product mfg and handling, which is why I feel like a new chapter somewhere between the two is warranted.

One thing im all for is that import equipment wont pass most inspections or audits so goodbye import equipment addiction.

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Yep, place I was at thought they wanted to be pharma level cGMP. It was instantly apparent they really didn’t want that because they had the same guy doing QA and QC.
A year of IQ/OQ/PQ, a SharePoint that completely broke because we exceeded the maximum amount of documents it could handle at any plan and several thousand pages of SOPs alone they finally realized they couldn’t go another year with essentially 0 products despite paying for a license and rent the entire time.
Between having 40% of your staff in the quality department alone and production slowing to a crawl it will cause operating costs to skyrocket in such a way that operators would have no chance of competing with the traditional market.

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If this is the case - they’re definitely doing it wrong. Should be less than 10%, best practice is somewhere around 5-6%. Right sizing quality is always hard.

The idea of continuous improvement - plans to get things in place while you continue operations based on risk (which is what the FDA asks for) understanding the minimum requirements (which are those 6 pillars, which I don’t know if anyone else calls them pillars, but clearly they are!).

Understanding that you don’t have to reinvent the wheel. That this stuff has been around for a while and that there are reasonably priced (expensive, but still reasonable to get to Part 11 compliant cGMO) QMS tools out there that will get you there faster.

Honestly - mostly what I see is a complete lack of understanding about what is supposed to be happening and what happens at pharma companies and large food producers.

We have this idea of “seed to sale” which has been thrust upon us by regulators… which I feel like many people understand well enough to look for the loopholes.

Its that same level of understanding under 117 or 211 or 820. Its part of doing business. And well, I’d say most of the businesses I have seen intimately had no plan for it, and really had no plan for cannabis that was based in reality at all. No long term planning, no understanding of taxation (which is gonna change!), no qc/qa to prevent major failtures from happening before they cost you hundreds of thousands.

I came to Michigan in 2020 - I saw three businesses right up front and got to dig around in their projections (which were bogus) and their plans (which spent way more money than they could ever make back). Two of them laughed at me and said I didn’t understand the industry (the owners of those companies no longer own them, both are in receivership - and a lot of people were left holding the bag…) and one of them said, Okay, lets try it a different way.

I won’t say that one is a super star. But they are still here - they have expanded (slowly and with deliberate planning) and they have an established QA/QC systems with well defined GACP and GMP SOPs in place.

The other two never really had a chance. And many of the others I have seen since then did not either. Their expectations of revenue generation were flawed (as many are seeing now!) and their understanding of the risks was minimal at best.

Maybe if we overcome those things people will start seeing cGMP for what it really is - risk mitigation for quality issues which can end your company quickly. And then it won’t seem so expensive anymore.

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As you know, this is very different than still being cGMP today lol. Maybe they are. If so, kudos. That’s impressive.
I’m not gonna say I’m 100% sure none exist, but I’d surely be surprised to see any.

This!! “We are ‘GMP Compliant’” but you go to the facility and they aren’t even close to cGMP standards lol… I saw it so often with Hemp companies.

It’s a TON of work. I went down that rabbit hole a bit with my previous company and they didn’t want to fork out the money or time to get it done, so I commend you for even starting two cannabis companies on cGMP principles. That’s impressive.

Like you said, most cannabis companies/operators just don’t really care about all the tracking and documentation that is associated with cGMP. Myself included, if I’m being honest.
I’m all for safety and and quality management, but do I think recreational weed should be held to the same type of standards as a big Pharma manufacturer?? Not really. A bit excessive in my opinion.
Not to mention, it slows production efficiency and raises operating costs in a big way. But I fear that’s where we’re headed.

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Well of course we shouldn’t be held to the same standards as say oral solid dosage facilities. And we definitely should not be held to the same standards as sterile manufacturing facilities.

But defining what those standards look like is what is important. I know we’re trying to do that over at ASTM. We don’t need to be Roche to do this work the right way. And its worth noting that a lot of pharma and food companies get this wrong all the time too. How many warning letters go out every year for this? How many times has Pfizer or Eli Lilly or Novartis been to court over these things?

The best part about this is that we can participate in the process for writing the standards and the regulations. We can do risk assessments to decide which things should be priorities - as long as we actually do them and document it that’s all part of cGMP as well.

If we look at something and can say that there is no science or quality reason to do a thing for our industry - then we don’t need to do it. But we still need to actually look and document our thought processes.

The difference in API vs derms vs oral dosage vs sterile injectables IS HUGE - but they all play under the same rules in 21CFR Part 211, you know? No reason we shouldn’t be able to right size this for ourselves as well.

But people are not even interested in doing that most of the time. Always makes me sad.

It worries me that people will not be able to compete with a level playing field when these companies get the reins loosed. Because they are doing risk assessments right now deciding NOT to participate in our booming/growing industry. But soon - those risk assessments will say a different thing.

And then all these people who haven’t even started to think about it will be competing with people who have best in class practices for efficiency and quality. :frowning:

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This is a good point. If we are going to be defining “Cannabis specific” standards, it would be a huge upside to be involved in that.
My fear is they just try to classify us into an existing set of standards, at least right out of the gate, rather than give us the chance to develop industry specific standards.

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I worked in biotech and at LivWell, and LivWell’s MIP was cGMP.

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Come to Philly in June 10 -12. Meet with other people writing these voluntary consensus standards. Its free for you to attend. <3

We’ll be talking about this and more during the committee week. We’ve already approved standards - that can be handed off to regulators to help bridge these processes today.

You can’t vote as a guest - but you sure can talk to people. You can look at the drafts. You can ask the important questions.

I’ll be there. Don’t let your voice not be heard - if you cannot come in person, there is video conference availability. I’m pretty sure you have to be a member for that and have access to a device that allows WebEx meetings. But its still possible!

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Thanks for sharing! Definitely something I’d like to attend.

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Things must have changed quite a bit because I have visited LivWell facilities when I lived in Colorado, just a few years ago… and they were certainly not up to cGMP standards.

Like Rocksteady said,

So, while companies may believe they are up to cGMP standards (and maybe they are), no one in this industry has been audited for it.

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They bought and rebuilt a new MIP in 2022. I’m not referring to their grows. They didn’t have audits, but they did everything they needed to in order to be cGMP compliant in the old MIP as well. I also don’t see how you would have visited the facilities unless you were getting a guided tour or worked in the facility.

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It was a guided tour… this was definitely prior to 2022. maybe 2020ish

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Not hard to get these. Guided tours not hard to get. I haven’t been in many years at this point but once upon a time I did visit the MIP in Colorado for a guided tour.

I’m not sure that is true. There has been an existing standard for about 18 months that people could have been audited against by the normal accrediting bodies. And there’s nothing preventing people looking at ISO 9001 accreditation (for QMS). And there’s nothing preventing people looking at SQF standards for food/edible production and getting audited and accredited for that as well.

I had to do that for two of my facilities in Michigan - and they came and waved their magic wands… and gave us a piece of paper and made us commit to continuous improvement and have come back twice since then to make sure we are staying committed (as they usually do).

Is that different than having the FDA come in? Or running an FDA licensed establishment? Sure is - because FDA doesn’t require a 3rd party accreditation. They don’t require ISO or SQF or ANAB or any of that stuff - AT ALL.

For them, demonstrating your quality system and filing the appropriate paperwork (like people do with many state licensed establishments) is sufficient. Whether we like it or not. Whether we think they need 3rd party or not. And whether or not we agree that all the thousands of FDA licensed establishments are actually cGMP or not. That’s just how it is.

For one of the facilities - there’s a lot more for us to do, but the bones are there and we make considerable effort along the path each month. For the other facility, I’m not involved anymore - but I did chat with the new director of operations recently and they were expanding more of their qualification efforts (we did very basic commissioning when I was there) and that sounds like something someone would only be doing if they were trying to maintain appropriate levels of quality for a cGMP environment.

I think the hardest part of all of this is that cGMP has always been subjective. One investigator will tell you all is well and another will come and shut your ass down.

Case in point - back in 2007 I was working for Aptuit. They had just recently passed an inspection by the FDA for their sterile clinical trial area. The powers that be in management decided they also wanted to be able to ship those materials into the UK for clinical trials there. So they invited the EMA to come out and do an inspection - the EMA sent the MHRA (UK FDA) - they showed up, took one look at the facility and immediately shut the whole fucking thing down. This meant almost 60% of all the products being made there could no longer be shipped to the EU. It meant 3 rounds of layoffs. It meant 18 months of me tirelessly working to learn how MHRA cGMP worked, fixing everything we were doing to meet the FDA’s requirements (which we had, multiple times!) and literally rewriting the quality system, sterile manufacturing protocols, and all supplier management controls.

I was a new project manager. I remember what it was like to be under consent decree. I remember what it was like to have them come out every 3 months and watching the “management team” get fired, over and over again because each time they came out we didn’t get approval.

Until finally, we did. And how much we learned. And how much we changed.

How much I learned and changed. I was just a sprout in this cGMP world, nothing like learning while the place is burning down around you. But that’s been almost 20 years now. And I remember the process. I remember how wrong many of the senior members of the team were. How many people were shut down by regulators who got to have the final say. How many people were shut down because they didn’t have an appropriate level of respect for the regulator.

And that’s how I help others now. Building on that experience. Looking at those processes. The ones that were broken and the ones that changed so things could be fixed.

But boy - most people they don’t even scratch the surface. And its like they are challenging the regulators to come out and fight them. As though, anyone wins that fight.

Since then I have seen people take regulators to court - and I haven’t seen anyone win. I have seen some settle and I’ve seen everyone else have to change their ways.

So I watch the warning letters and the 483’s. And I listen to what the regulators are saying. And I watch the courts for opinions which might make the rules more flexible.

And all the while I work with other people to create voluntary standards I think will be more flexible to allow for innovation while also keeping consumers safe. Because after all - these rules are supposed to keep us safe from adulterants and mislabeled materials - you know?

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Its not that easy to get a guided tour. There needs to be a reason for you to be there, and the owners and managers have to approve it and spend time giving the tour. I’m not sure what their attitude was pre COVID, but after COVID they gave tour every week but it was to prospective buyers, then they were acquired by Pharmacann, and then the tours stopped.

IMO the grows, cure, and trim areas were definitely not cGMP.

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cGMP refers specifically to the regulations and guidelines set by the FDA. And being that cannabinoids are not FDA approved they are not subject to the same scrutiny of pharmaceuticals.

Ergo no real official audits have taken place for true cGMP for a cannabis company.

That said It’s a bit more nuanced then that though, as there are cGMP API manufacturers stateside that do manufacture cannabinoids APIs ie dronabinol, Epidiolex, and Sativex; but these are massive pharma companies, that were pharma companies first that just picked up new skus that happened to be cannabinoids, and afaik their products are completely synthetic; derived from a total synthesis and not naturally derived. There’s a massive shortage of these products in the US though.

Also Jazz pharmaceuticals has a US cGMP cannabinoid research facility, but it’s only for research and product development and product deployment. There’s probably a few more sites like that across the USA. But like I said these were pharma companies first, that picked up cannabinoids long after they were audited and accredited by the FDA for cGMP status.

Also Iso is great, it looks good for investors and should be done; but essentially you get your ISO accreditation 9001 or 22000 for your quality management systems to make the accreditation from the FDA less painful; imo. Iso does not mean your cGMP by any stretch of the imagination.

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What standards though? There are no cannabis-specific standards, as far as I know?

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