Could I ask this forum on where in the value chain global GAP ends and GMP starts? Specific in relation to EU GMP medical cannabis requirements.
Oooo! You bring an exciting one.
In my experience - Global GAP merges with GMP after your receive the raw material and issue it to a GMP batch for processing. So for instance - let us say that you are producing…sugar from beets. muhahaha, didn’t think I was gonna say sugar did you? Global GAP would cover the farm, harvesting equipment, clean-up equipment, transportation, and storage of the beets. From that you would have a Certificate of Conformance that you could issue that would say you have been following all the rules, that your product was planted, harvested, and licensed according to Good Agricultural Practices (you know clean hands, clean water, clean soil, etc.) and that it has been stored in appropriate conditions during transportation and storage.
Once the sugar producer gets your beets - then boom, now its handled under GMP (or probably more like SQF, but they are very similar). Let us assume this sugar is going to go into drug products - and so it will be processed in a plant that using Good Manufacturing Practices. This is very well defined in the EU by the EMEA for APIs, excipients, intermediates, and drug products, as well as cosmetics and vitamins. Sadly, for cannabis products - this is defined by each individual member state, similar to how things are handled in the US. So you won’t be able to use the umbrella rules to cover all your bases.
If this is something that you are wanting to do - then you need to find yourself a QP in the EU (if you are importing for sure). The QP will be getting you permission to do clinical trials and the like (it is possible although difficult).
I haven’t seen anything that implies that you can move THC medical cannabis or its extracts through the all EU member states. So let us assume that you are talking about low or THC-free cannabis.
Each EU member state has its own policy on medical cannabis and CBD/hemp products - so the transition from GAP to GMP, transportation, harvest, testing, etc. Will be dependent on both where things are bring grown, which places things are being transported through, and where the product is being processed or sold.
Probably I have given you enough information to dig out what you are seeking. If not, then we’ll need to know more. Like which countries, what kind of products, etc. Some countries are super lenient others are much worse than you could ever imagine the US to be.
Good luck with your search.
Thank you sugar
Thank you for this and the refreshing example of beets and sugar always nice to draw parallels from other industries. Would you assign drying and curing as a GAP responsibility or GMP should have already stepped in for quality management at this point?
Personally - I put drying and curing in GMP - but I don’t do any in field drying and curing activities. So it would be very dependent on when and how you are drying.
If you are drying in field or during harvesting that’s going to be GAP, in my opinion. If you are harvesting everything and then hauling it all to a second facility and handling it at that facility then it would be GMP (or SQF). Certainly if you are doing any post shucking or trimming curing activities - I would think you’d want those GMP, if only to maintain good control on micro organisms as well as to maintain appropriate monitoring of the curing process. However, for things like tobacco - drying and curing is firmly in GAP, but then its all done basically at the point of harvest and not carted all over the place.
I’m also a firm believer in holistic quality management. That means you do things in a GMP way, with written instructions and monitoring of practices from Soil to Sale. There’s also such things as GDP (good distribution practices) for when you are transporting things. That overlaps with GAP and GMP as well.
Now you’re making me want to draw up a venn diagram that shows how things overlap. I might get to that this weekend, never know.
The mention of tobacco with GAP setting the standard for drying and curing makes me wonder are there examples of other botanical API’s that that are being extracted and reformulated into clinical dosage form? The point of having drying and curing fall under GMP makes sense considering the end goal is ‘medicinal’ product. Just not seeing this always in practice with both approaches to curing applied (GMP or GAP). Again I suppose the approach you opt for all ties back to offtake agreement and EU country and their definition within the quality chain.
This is totally the case. There are a lot of botanical based Active Pharmaceutical Ingredients for both oral solid dosage and topicals. Palm Oil and Coconut Oil are probably some you are readily aware of, but many emulsifiers and other items come from agricultural products as well.
In the US the FDA even has a specific guidance for the usage of materials of botanical origin, as well as, the US Pharmacopeia which clearly outlines how to test botanical materials. Even products from animals have similar guidance and expectation - for both the GAP and GMP stages of production. A special inclusion would be products from cows which per GAP and GMP now must come certified free of Mad Cow disease - if you want to sell them in the EU, which is nearly impossible to source in the US, so you have to go to other places like Australia to source your materials and they always come with a GAP certificate of conformance.
But I digress. In general in cannabis - I see a lot of people with a lack of focus on doing things either GAP or GMP until regulators tell them to do so and also come to enforce those requirements. Even in places where regulations have been in place for quite a while (like say Colorado) and where results are published in the public domain - you still see failures for pesticides that should never be used, micro-organisms which are totally preventable with clean work spaces, and a dizzying amount of random “potency” results coming from god only knows what instrument (is there really an instrument…I heard Adobe makes COAs just fine…)
For cannabis products in the EU - each member state has their own requirements. In most cases they are all various interpretations of best practices laid out as cGMP. I have not seen any that don’t call for at least some GMP provisions regarding patient safety and cleanliness.
Some more examples of other botanical products:
- Palm and coconut oil (often harvested and pressed at the same location/facility) excipients for topicals and foods
- White Willow Bark - natural aspirin precursor
- Sugars (fructose, sucrose, glucose)
- Essential Oils used as flavorings
- Citric Acid - byproducts from a number of citrus fruits
- Acetic Acid - byproduct from a number of fermentations of plants
Really enjoy your conversational style I have also dealt with animal products that needed to be BSE free so it is a good example. Lets await a hopeful cannabis MRA for Europe down the pipeline to help clarify.