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Is Ethanol Extraction GMP Compliance?

The whole point of being GMP compliance is that the final product has always the same consistency and reproducibility.

Let's assume we make a first ethanol extraction with fresh ethanol and then recover that solvent in a roto evaporator
This recovered ethanol is no longer pure, so it is no possible to reintroduce it to the process and make a second or third run because it can have cannabinoids or terpenes attached.

If my facility wants to be GMP compliance we will need to use fresh ethanol every extraction? This will make the operation unaffordable in the long term

If the ethanol can be re-purified in order to make it fresh again does this ethanol need to be certified by a 3rd-party laboratory in order to assure that it doesn't have any terpenes or cannabinoid remaining?

Comments

  • Spent all year flying around europe talking to lawyers trying to figure this out. Short answer is ethanol extraction is GMP compliant. Longer answer is that achieving GMP certification has less to do with your end product and more to do with the documentation process of manufacturing your equipment and SOP's. your facility must be up to whatever standard you're aiming for, in the case of hemp, a food grade facility is fine in most of europe, but in the case of THC and medical plants, you're basically going to need a clean room and a minimum of a year to get the GMP approval. you'll need to hire one or more people to have this be their number one focus, and even then its a big risk as many of these regulations in europe are due to change as they open up to the larger market. alternatively, you can get GMP certified for a packaging operation, order isolate from the US, and bottle it in your GMP facility, and be totally in compliance.

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