We are in Florida. We are a cbd extraction facility doing contracted extraction and wholesale distribution of of end products and raw cbd.
Just looking for our options and what the process would entail and all that good stuff.
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Correct me if Iām wrong but doesnāt little c stand for current, denoting the ever-changing state of what is considered good in manufacturing practices?
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^^ Thatās what I thought.
From cMP to GMP makes senseā¦
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thereās a TON of misconceptions and confusing around cGMP and GMP. Iād recommend you look it up. Considering youāll have to be GMP before the end of next year probably.
But yes somewhat of a large difference between cgmp and GMP.
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cGMP is the higher standard of the two afaik. I do have a partner whoās a professional GMP consultant in food industry though. Perhaps they could help you out.
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Definitely worth talking to. Iād prefer to use someone whoās brought a processing lab to GMP tho as there are some unique issues with us compared to food industry tho.
From the literature Iāve read and the GMP certification companies weāve spoken to, cgmp as it applies to us is mainly verification of supply chain and hazard prevention etc. and GMP is more operational based and that kind of thing. But I could be wrong. Hence the consultant
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In our state, the Dept of Health does cGMP inspections (food establishment, drug mfg etc); Our inspectors are pretty great about doing a walk-thru and pointing out what youād need ā even printing off their checklist so you can use it to make modifications.
Quick free and modifications that are directly on point to the inspection. Might be worth a call to see if your dept of health handles the same.
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I think you got those mixed up. If youāre cGMP, youāre up to date on GMP procedure. So you want to go back to a less current standard, thereby losing current certifications?
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When I was introduced to gmp the lesson was that it was once okay to pipette by mouth and not use gloves in both chemical and biological labs. That isnāt currently accepted as good but it once was GMP. So cGMP was coined and states youāre up to date with currently accepted practices, acknowledging that practices that once weāre acceptable and standard are not such any longer. I think you are saying that youāre GMP by practice and you want to receive an audit.
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If one thing is clear from this thread its the lack of clarity everyone has on cGMP vs GMP.
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In short: one up one down supply chain visibility and records at a minimum. Botanicals cultivated under GACP. Repeatable, documented processes. Acceptance criteria for the output of each step. 3A equipment and traceability/source of supply. Documented cleaning procedures. Lot and batch tracking. And a metal detector.
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This. So we have all of that short of 3A equipment section as I need to look into that. But then need someone to do a mock audit for us and then help implement any changes need to be put in place and then assist us getting our official audit
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You have to choose the GMP you are doing then look at your associated docs. The GMP I was trained on was in the scope of 21CFR210/211 for drug manufacturing. Iāve never had hands on experience on what hemp guys are doing but thereās other CFRās for other things like food and cosmetics.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=210&showFR=1
I donāt think there are ālevelsā to GMP-ness. A previous employer had a line of DNA titled GMP-S to denote that it was made using GMP principles, paperwork and auditing, just not produced in a balls-to-the-walls outfitted drug manufacturing suite(s) like true GMP drug product. That is the only case Iāve experienced where GMP was different in any way (in the drug manufacturing world).
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Let me know if you are still looking for a GMP consultantā¦ https://www.compliancebydesigns.com/
We specialize in this for CBD and Biotech / Phamra
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There is a huge difference between cGMP for food and nutraceutical and pharmaceutical GMP - and then a difference between USA pharma GMP (cGMP for pharma) and EU GMP or PIC/S GMP.
Almost all USA manufacturers only have food grade or nutraceutical grade GMP/cGMP - they are not operating at true pharma expectations.
International buyers and the pharma/medical industry expect pharma GMP - not food grade.
Thatās where the gap is. Most of it comes down to documenting potency, safety, purity of active ingredients throughout supply chain, along with track and trace and recall requirements.
Hope that helps people understand some of the nuance within GMP and why US CBD still has a long way to go even though increasing numbers of labs has some GMP certification
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Iāve addressed this issue beforeābut I just want to be super clear. The ācā in cGMP stands for ācurrentā.
The term was created to foster a sense of continuous improvement in GMP environmentsā¦meaning that manufacturers should be forward-looking and design their operation in a way that allows for future changes that will improve compliance.
There seems to be some kind of idea in cannabis that going from cGMP to GMP is better, but Iām so confused, because itās the opposite in pharma.
Who says that GMP is an upgrade from cGMP and where is the reference for rhis?
In my mind, itās more like youāre talking about 21CFR and which subsequent component of 21CFR your business is in:
21 CFR 110 is a designation for the cGMP regulation of food products and cosmetics.
21 CFR 210 is a designation for the cGMP regulation of pharmaceuticals.
I can help thereā¦but I mainly came here to say: GMP IS NOT AN UPGRADE FROM CGMP!!!
Love,
Phil
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Is anyone on this forum sitting on a 21 CFR 210/211 GMP accreditation for pharma? Specifically as it relates to receiving GACP flower then taking it through to distillate or isolate under 21 CFR 210/211.
Ive got the software for it 
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Based on the title of this topic, I wanted to say āSure I can help I will take all your current SOPs and QMS docs and update it to what was publicly available in the year 2000 and your cGMP would now be GMPā but @TheGratefulPhil made this point very clear 
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