Hello everyone! We are ISO a gmp certified facility to manufacture some products for us. Ideally, we would like to work with a company in Southern California, but we are open to other options.
Seeing as the actual regulatory bodies like the USFDA and the CDFA dont actually certify facilities ( the assumption is any facility selling food/supplements is in compliance, and when they inspect they issue citations for failing to meet standards) you wont find anything beyond third party certifications which AFAIK are completely meaningless. Basically anyone claiming to be a “GMP certified facility” is blowing smoke right up ur ass.
Of course we all know this industry is a total shitshow so mayyyybe a third party certification is useful but then you have to go track down who did the certification, and find out how good THEY were since the state and fed regulatory agencies dont certify, only hammer violators
I’ve heard true terpenes is GMP certified
Interesting… so all these guys stamping their tinctures etc with gmp stamps are bullshitting??
maybe, but also important to consider here is Co-packer’s facility. The co-packer can be cGMP and verified as they have nothing to do with the actual mfg of the hemp/canna based “bulk dietary ingredient”(exctract/tincture/etc). The diff is in CFR’s 111 vs 211. 111 is way easier to meet and is for “bulk dietary ingredients mfg” they cant package retail products. 211 can, this is where co-packers offer value and can produce retail packages for consumption. building a 111 type facility/business is a bit easier and cheaper than 211, which is why almost everything is co-packed.
@CollectiveObjective great insight, thanks! Any direction on how to track some of these places down?
tracking down a co-packer or the CFRs for 111/211? I bet @TheGratefulPhil can elaborate, he definitely hip to cGMP all around. I think hes worked in a 211 facility too.
My old company was 111, and we sent kilos down the street to a 211 facility with API certs for the compounds we made that were destined for Active Pharmaceutical Ingredients, this was non-canna tho, but it is an example of a business case where one may choose to go 111 because it can be cheaper to partner with a 211 type facility than to go full 211 out the gate. Theres also other designations im not experienced with that phil can elaborate on here
I did indeed work at a 211 facility, I’m not familiar with any cannabis operations that advertise themselves this way.
You’ll have to go the full route of materials testing, process, equipment, cleaning, sterilization validations and if you hope to automate you’ll have to get data validations going.
There’s way too much information to spell out here…any specifics I can help with?
I have access to GMP facility in Utah with hemp processing license Currently making topicals and drops. email@example.com my name is Scott.
Look into Aliance Nutra! They do specialized production for 3rd parties and are GMP compliant
Literally JUST got off the phone with FOCUS two minutes ago, who is currently contracted with AFTA in developing the global GMP standards for cannabis businesses.
In short, there are NO GMP standards yet for cannabis businesses. These companies that are claiming they are GMP Certified are either 1. Lying, or 2. GMP Certified in something other than cannabis (food, cosmetics, etc.) and are using that as a marketing ploy.
Also, do not confuse GMP Compliant with GMP certified. There is a difference.
She told me that cannabis based business will have GMP standards to abide by probably beginning of 2020. Then the floodgates will open and everyone will be getting those GMP certs for hemp/mj.
So GMP is an audit of your operations. There’s very few industries that have an industry wide GMP standard and theres no way one company is going to standardize it, particularly in this industry. There are best practices. There are trade secrets. There are patented processes. But hardly industry wide GMP. Unless theres an ANSI, ISO, consensus standard, or prescribed regulatory process, then GMP certification will vary from business to business.
For example, a cake is a cake. But two separate bakers at two separate businesses use different processes to make that cake. GMP is really intended to reduce batch to batch variability within an individual business so that the end consumer gets the same product six months from now that they just bought last week from ABC Extracts, regardless if it was Joe or Tom who made it.
Also, The FDA has GMP suggestions and once they classify CBD as as (hopefully) supplement or (please not that would suck for anyone other than CW etc) pharmaceutical or (ehhhhh) a food then everyone making CBD products MUST be GMP. The FDA doesn’t care about the certification, they’ll just go in and inspect and if you are slipping they’ll take corrective action, the severity of which is depended on the egregiousness of the problem
I am gmp. USA only and documented manufacturing lines. No cheap corners cut. Let me know what you want made.
Yes. But there are people hiring out there that are hiring their buddy at “so and so safety” to come “audit” them and then saying they are GMP Compliant. That is much different than getting an actual GMP certification from the HSA.
And you’re right, not one company will set the standards. But there are different standards from industry to industry. Different items to check off their audit checklist, if you will. Some things are the same across all industries, yes. But there will be some differences in the audits across industries as well. There are things that they will look for in their audit for a food company that they would not look for when auditing a cosmetic company.
So what I am trying to say is there is not a set of standards specific to Hemp/CBD/MJ companies right now. Not yet. But there will be soon, I am being told. And there are multiple companies that are helping to develop these standards. Just like there are standards that are specific to the food industry and to the cosmetic industry.
Sorry to disagree
I have been in several extraction facilities and one novel foods extraction facility (gmp)that also extracts hemp
The list of things he has to comply with is staggering and i can assure you it is
A very transparent extraction process
Where everything is writen down and sanatized
Yea from what I know the FDA doesn’t issue any certifications of being “GMP” complaint. As you articulated very well, the assumption is that a facility is operating consistent with Code of Federal Regulations and the FDA comes to do an audit to see if you are complaint with the CFRs and if not they wrote a 483 report.