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 producingā¦sugar from beets. muhahaha, didnāt 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 wonāt 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 havenāt 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 weāll 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.
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Thank you sugar 
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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?
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Personally - I put drying and curing in GMP - but I donāt 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 thatās 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 youād 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.
Iām 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. Thereās also such things as GDP (good distribution practices) for when you are transporting things. That overlaps with GAP and GMP as well.
Now youāre making me want to draw up a venn diagram that shows how things overlap. I might get to that this weekend, never know.
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The mention of tobacco with GAP setting the standard for drying and curing makes me wonder are there examples of other botanical APIās 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 āmedicinalā 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 āpotencyā results coming from god only knows what instrument (is there really an instrumentā¦I heard Adobe makes COAs just fineā¦)
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 donāt 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
Etc.
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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.
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Interested to hear more related to the transition between GACP to GMP?
Are you offering or asking? Your handle would suggest the former.
I know the OP asked about EU, but in the US the answer is: it depends; on many factors.
This may be(is) off the subject but since tobacco was mentioned, are the cigars that I smoke from various countries subject to pesticide testing or are my lungs assuredly pest free now?
High probability that they were not subject to pesticide testing.
GMP Begins when you define it and start doing it.
In practice for outdoor hemp this means when it arrives, packed and weighed and tested in quarantine at a GMP facility intake area.
Then GMP starts, typically with the specified testing regime required to to being turning the input material(eg: Clean dry, selected dry processed herbal plant material or resin) into a standardised GMP product (eg: Standardised Extract or finished product).
As part of GMP the processor will have specified the material they want and have a documented contract and quality agreement with the supplier.
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In short - pesticides are legal for use on Tobacco, regardless of whether it is imported. Tobacco is a very pesticide intensive cultivation both during growing and post-harvest activities.
There are some research studies that have been performed on this in the early 2000ās. These practices have not stopped. The FDA taking over tobacco regulation, does not appear to have changed these. Things that are illegal in many states to find in cannabis, are legal in tobacco. But then they hardly have limits on heavy metals and micro contaminates either.
The FDA has an entire division now that does this work. They maintain a list of all the things that are currently in tobacco (there are not laws preventing thisā¦just you know, labeling that says tobacco will kill you, cause it will kill youā¦) Check it out here.
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In what enviromwnt is then tobacco devided, distributed into smoking form and then packaged?
Because its not a food consumable product would you say a simple HACCP is enough? Or is it sometype of GMP non related to cosmetic and medicament production.
Because packaging tracebility is a part of GAP for tomatoes for exapleā¦ And if your making a sauce and jarring it is a food safety HACCP and your done in the EU.
So hemp flowers for CBD purposes falls into a special category since in the EU there is much ambiguiesness do to EFSA and EU parlament ruligns, crossed with local regulations of each member state.
So yeah it depends where you are placed in this world and who your final customer will be.
In my experience - it is either cured under GAP in large barns. Or cured in a GMP facility there its baled, bucked, ground, sifted, and processed all in the same location (like almost a full line where bales go in one end and cartons of tobacco products come out the other).
Hereās a couple videos that show the different methods pretty well.
Old school - barn dried and cured in a sub-tropical environment.
Super Crazy fast method for baled/bucked/ground/mixed.
One uses mother nature to finish things off. The other uses a commercial drier with balers and buckers.
For Tobacco in the US - its got its own series of rules under the FDA - which is different from food and pharma. HACCP is not enough in the US - many other countries donāt have this special category for tobacco.
And for sure I 100% agree that what country you are in and what your end product will become drives which regulations you are governed by. I figure that is for all commodities though, not just hemp and hemp products.
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In theory GAP ends when you harvest.
The way you handle plant material is GACP if your making medicine from the plant
If your collecting for seed your GAP till you dry thw seed and pack it up for sales.
If your cannabis flos will reach pharmaciea it depends, they could buy your GACP biomass and pack it in GMP.
If youāll be selling flowers directly into a pharmacy, you could GMP start in the second you bring the cut the plant to the drying chambers(GMP validated machinery clean spaces etc,.) and remove it from your space of cultivation, be it outdoor greenhouse or indoor. The process can be still GAP separation of flowrs and directly set into GMP drying.
The reason why OD GH flowrs arent to be sold in pharmacies most of the time is either sloppy paperwork, sanitational aspects unattended, that lead to micoorganism contamination. This do not meet the safety demands of a imunosupressed cancer patient vaping for medical relief. It could be even due to natural occurences wich you have nonpower over (heavy rains promote fungus growth, unclean hands during harvest, a flock of birds passing by shitting allover).
So for exrtaction biomsss, mostly you wanna be GMP as late as possible when you scale from 10ha - 100ha farm, and actually do the drying strippn and segregation of the material in GAP packit up and send it over to Cassin for GMP (with pending analyiss acredited CBX CoA, MO, HM, FFA). And probably hell make a labgrade 99.7% making just isolate cause the biomass is 14% dried and packaged in bigbags with a plastic wrapp and a lot no.
You could theoretically do it outdoor for pharmacies, people have done it, but they had a top quality sealed warehouse with industrial humidity control and PVC cloathing the whole space, but their protocol was very very cleanly and had HACCP written allover itā¦ Sadly the buyer went for an indoor producer of lower quality and higher ā¬ā¬ā¬ in all aspects, justifining the backout with limited reproducibility of the product and so trust that next year will be similar is lowā¦ The flower passed MO, HVM, FFA with freaking flying colors mind you and is the best CBD bud Cannafest 2018 had to ingest(peoples comments on the stand)
Personally i feel that natural drying procedures allowing natural airflow and coming into contact with the for example maritine air makes a special touch to the metabolites ripening but if it promotes a fungal growth in storage cause the moisture contetnt probably is above 0.6WA. cant say its wise to play around eith thousands of ā¬ of biomass just cause you wanna be something special and difderentiate yourself from the market.
And if you blow it your local GMO facility wont be happy went they redo the MO and metabolite testts.
Hope it helped a bit to a confusing case by case specific aswerā¦
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I know the answer but, but it was/continues to be costly 
Not trying to be cheeky, Iād share the info if it wasnāt so dear.
Tilray is using the same methods doing it through Uruguay, into Portugal and onward distro into Germany.
According to my experience with cannabis and EUGMP (the real āpharmaā one) I would rephrase that to:
GMP begins where your drug regulatory authority defines it.