Who have you used or heard of for 3rd party GMP Certification?
With the recently passed USDA bill, I have a feeling this will become a requirement of hemp processing facilities and want to stay ahead of the curve.
I have reviewed the FDA proposed tobacco GMP, Pharmaceutical GMP, and CFR 111. Maybe I’m missing something but it really seems like its all about documentation of all aspects rather than an inspection or something.
Any suggestions are much appreciated.
Following…
FSSC 22000, ISO, et al.
NSF is a company that does a third party certification. End of the day it’s just about passing FDA audits and that will maintain your gmp or cgmp status.
And what you said is 100% correct.
Only way to be able to sell to pharma.
NSF does the usada and athlete supplement certification also, which might be really good to have if you’re in the space.
I’m not so sure about GMP becoming law in the US. Enforcement becomes an issue because it costs quite a bit. Does the US require cGMP certification for all supplements?
Nope.
In fact, most are not.
Is not a law to be certified, but if the FDA comes in for an inspection they might drop the hammer if they don’t like what they see
I gotcha. I’m 100% ok with that. There has to be some standards.
My compliance officer is amazing and I’d love to put you in touch with her, shoot me a DM
documentation is everything if one wants to be “cGMP”.