+1 in BC (lower mainland)
MMPR Grow op: Small Scale
- Thread starter maximum
- Start date
The test for the microbial contaminants listed in the European Pharmacopoeia is a pretty standard series of tests where you grind a known amount of tissue, prepare a series of diutions, and plate them out on a variety of selective media. In order to do this you would need a basic microbiology lab that includes an autoclave (or pressure cooker), a laminar flow hood, a growth cabinet (could build it), and an assortment of basic lab equipment (pippettes, balances, chemicals, etc.). Of course, you will also need to be familiar with basic microbiological methods and general lab work.
As for the chemical contaminants, this is a little more complicated. For example, for pesticide residues, there are over 1000 compounds that are considered pesticides and there is no single method that can detect them all. As such, the pesticides that need to be tested vary depending on the crop and which ones would be more likely to be found. In the European pharmacopoeia, it states that the requirement for pesticide residue analysis can be exempted if the full history of the crop is known and it was produced using good agricultural/manufacturing practices. In the case of medical Cannabis, the full history of the crop is known, we must use good manufacturing practices, and since there are no pesticides registered for the crop, there would be no residue. As such, based on the European pharmacopoeia, we may not need to test for them at all, but this will depend on how HC interprets this.
Personally, I think that I will follow the European pharmacopoeias methods, as Europe tends to be a little more active in the area of standardizing herbal medicines IMO.As I mentioned in a previous post, we are planning on setting up a lab for these tests and would likely be interested in offering these services to other growers in order to make it an economically feasible option.
We are also thinking about developing a tissue culture component to the lab to establish a germplasm collection so that we can produce a variety of different cultivars without having to maintain a large number of mother plants. We have toyed with the idea of offering this service on contract as well, where we would maintain a clonal genetic library in our tissue culture lab so that we could provide elite genetics. I dont know how familiar everyone is with tissue culture technologies, but this would allow us to clonally maintain large numbers of mother plants, and the plants are maintained in a sterile environment so there is no risk of transmitting insects or diseases with the plants. At the moment we are just weighing our options, but we would like to know if there would be interest in this? Of course, this all depends on if we are able to get a license....
Regarding the Co-op idea, we have been discussing the very same thing for a while. I think that it would be valuable to look to various growers' associations to see how they have organized. They are critical in lobbying the government and they are the driving force that leads to university based research. Here are a couple links for reference:
http://www.ccga.ca/Pages/Default.aspx
http://www.canadianchristmastrees.ca/
http://www.canadianmushroom.com/
http://www.ccga.ca/Pages/Default.aspx
http://www.canadianchristmastrees.ca/
http://www.canadianmushroom.com/
redi jedi
Well-Known Member
I would be interested in using your services. What Province are you in?
westcoast420
Well-Known Member
So Ive smoked weed for 20 years, does that mean I qualify as a QA person? Well since there are NO requirements for this position I guess the answer would be yes. Didnt HC even say there are no requirements and they dont even check what you put down for the persons qualifications?
We are in ON, I guess I should update my profile a little...
I dont know where you read that; this is what they have to say:
"This employee must have the training, experience and technical knowledge related to the proposed licensed activities and the requirements of the MMPR. The applicant must submit a document signed and dated by the quality assurance person that includes:
- a description of the quality assurance person's qualifications in respect of the proposed licensed activities and the requirement of the MMPR; and
- a report establishing that the buildings, equipment and proposed sanitation program to be used in conducting the proposed activities referred in the MMPR comply with the regulatory requirements.
From this it sounds like they will evaluate the qualifications of the QA person on a case by case basis. While they do not specify that there are any specific requirements, I would not interpret that as meaning that as meaning that there are no requirements or that they will not check what you put down. On the contrary, I would read this to mean that you need to justify why the QA person's background is suitable, in other words the onus is on you.
The other thing that this section implies is that the pre-licensing inspection is not only concerned with security, but also includes your drying, packaging, and other relevant facilities. The QA person must write a report regarding the sanitation methods to be implemented, and they say they will inspect the site to make sure those measures are as described.
Also foudn this:
"This means that the Quality Assurance person must have the ability to evaluate the operations of the LP to ensure compliance with Division 4, and the technical knowledge to be able to assess analytical testing results in order to be able to make the determination of whether the dried marihuana is suitable for sale. The Quality Assurance person is also responsible for investigating quality-related complaints and taking corrective and preventive actions, if necessary."
redi jedi
Well-Known Member
Its obvious you haven't even read the regulations....
Kootenaygirl
Active Member
Great post(#223) kron3007, regarding microbial analysis. We also thought the European Pharmacopoeia was the one to use. All about HC’s interpretation like you said. We are beginning to write out our procedures and it is difficult to keep it simple and not get too wordy. Even still we are coming up with new things that we need procedures for. Lotsa work but seems straightforward enough. We would also be interested in your service, and wonder if the distance and or winter time shipping will effect anything.
We need to organize. We need a leader. We will contribute.
We agree with westcoast420 when it comes to the qualifications for a QAP, though also believe the regs weren’t fully read. You would need to learn a few new tricks and procedures and maybe grow it, not just smoke it for 20 years but really he is right about the lack of substantial qualifications needed. We shouldn’t get our panties in a knot over this area of the MMPR, we think that as a farmer you will be your own QAP no problem.
Lots of people may not be able to mention their experience without incriminating themselves. Any thoughts about this issue?
We have run into a small issue. Our building permit department has made it necessary for us to treat our op as an agricultural space, seems reasonable enough. Even though we are fully up to code now we will have to make some electrical changes such as replace all our wire from 14-2 in a pipe and braided to some kind of water or humidity proof wire in PVC. We know this will not be our last setback, “buck up with your chin up“.
Is anybody close to sending in an LP app. yet? We may be ready in a month depending on HC’s response and inspection schedule. If they have one LOL.
Do you think that patients will order the maximum 150g shipments because of the pain in the ass (pita factor) of paperwork and that it would probably be cheaper due to the shipping. Or are we gonna see 10 g’s here and 30 there as they mix it up? Lotsa boxes and childproof containers or just a few?
What about the lack of advertising? Can we ship it to our clients in the form of fridge magnets?, on our websites?, and why can’t we get an ad after the cialis ad on TV?, Do you smoke after sex? LOL. Because it is Narcotics? Seriously though, no advertising to the general public, so we can aim our ads to a smaller audience like what? I see that they warn about addictiveness on TV now. Unclear what the rules are unless you think zero advertising really means zero. Display an N on the upper left corner of your brochures that you can hand to who? Will HC really be our only way to let the masses know? What would big Pharma do? end/rant. Just stirring up the pot a bit.
We need to organize. We need a leader. We will contribute.
We agree with westcoast420 when it comes to the qualifications for a QAP, though also believe the regs weren’t fully read. You would need to learn a few new tricks and procedures and maybe grow it, not just smoke it for 20 years but really he is right about the lack of substantial qualifications needed. We shouldn’t get our panties in a knot over this area of the MMPR, we think that as a farmer you will be your own QAP no problem.
Lots of people may not be able to mention their experience without incriminating themselves. Any thoughts about this issue?
We have run into a small issue. Our building permit department has made it necessary for us to treat our op as an agricultural space, seems reasonable enough. Even though we are fully up to code now we will have to make some electrical changes such as replace all our wire from 14-2 in a pipe and braided to some kind of water or humidity proof wire in PVC. We know this will not be our last setback, “buck up with your chin up“.
Is anybody close to sending in an LP app. yet? We may be ready in a month depending on HC’s response and inspection schedule. If they have one LOL.
Do you think that patients will order the maximum 150g shipments because of the pain in the ass (pita factor) of paperwork and that it would probably be cheaper due to the shipping. Or are we gonna see 10 g’s here and 30 there as they mix it up? Lotsa boxes and childproof containers or just a few?
What about the lack of advertising? Can we ship it to our clients in the form of fridge magnets?, on our websites?, and why can’t we get an ad after the cialis ad on TV?, Do you smoke after sex? LOL. Because it is Narcotics? Seriously though, no advertising to the general public, so we can aim our ads to a smaller audience like what? I see that they warn about addictiveness on TV now. Unclear what the rules are unless you think zero advertising really means zero. Display an N on the upper left corner of your brochures that you can hand to who? Will HC really be our only way to let the masses know? What would big Pharma do? end/rant. Just stirring up the pot a bit.
R.Raider
Well-Known Member
Perhaps people can just mention their growing experience but maybe not mention that it was cannabis inclusively?
westcoast420
Well-Known Member
So before people start getting all mad about my comment, it was more of a joke, obviously.. but in all seriousness the whole part about a QA person is a joke! I have read the regs, several times. I find it funny how they say this QA person should have the training and knowledge to assess the product and test it etc and yet they dont list any requirements this person needs to have. Honestly I believe HC is just putting up a front like you need to have scientists as QA person when in actuality someone with general growing experience and can use a THC test kit will be fine. I believe all they truly care about is your security measures. Even the part about testing for pesticides makes no sense, they say it must be below exceptable levels as laid out in the FDA, except there are no specific levels for medical marijuana as its a health product not a food product. Wow HC makes me mad
I dont know why you would assume that. You could be right, but there really is no way to know. I personally suspect that they have left it so vague for two reasons; a) so that they can accept reject at their discretion making it difficult to appeal, and b) so that people are less likely/able to fudge their applications so that it fits the stated criteria.
I also doubt that they will accept the THC test kits, or at least the TLC based ones I have seen. They are not very accurate and not really suitable for chemical quantification. The standard in the pharmaceutical/neutraceutical world, which this is meant to be in line with, is HPLC analysis using validated methods and running the required standards. This dosnt mean that you need to be able to do this yourself, but you would likely have to outsource if you cant IMO.
Another thing to remember is that a large number of applications that they receive will have scientists and the like as their QA person (I know of a few groups with this in place). Just because they are not putting an official limit on the numbers dosnt mean that they are going to give out unlimited licenses either. You should keep in mind the backgrounds of the people employed by health Canada, it may give some insight into how they would evaluate this. I dont mean to be negative about all of this, but you need to be realistic about it. I hope that you prove me wrong with your application, but I personally think it would be wise to play it on the safer side and take the QAP seriously.
Also, regarding the pesticides, from what I read they refer you to the Pest Control Products Act for maximum limits, not the FDA. There are no pesticides registered at the moment, but they likely included this with the foresight that there may be some in the future and they need to have it included in the MMPR. From my interpretation of the MMPR, there would be no requirement for pesticide analysis at this time...
Distance and weather would not effect the chemical or microbial analyses. The distance would be no major problem for the tissue cultured plants, but the weather would present some issues. That being said, the problems are not insurmountable but need to be considered.
Kootenaygirl
Active Member
Nobody knows about the QAP, true that. But here's what I think we know: it will be someone in house, in the qualification range between scientist and accountant, maybe less, can be the SPIC or the RPIC, must be literate, must pass a 10 year security check, is knowledgable about growing and processing marihuana, can follow procedures, and can read test results. (Look in the mirror.)
These do not seem that difficult to surmount, it's all in the procedures. I think that anybody that can run a successfull grow room can be the Quality Assurance Person. Your already doing just that, learn a few new steps in your already intense effort for quality. Mainly verification steps, it will be like wearing your helmet or fastening your seatbelt, after a while it will become second nature and you'll stop cursing the rules. Has anyone else started writing out procedures yet?
I heard a rumor, (firsthand), once removed, that I believe to be true for reasons I cannot divulge. (famous last words) I heard that HC did give a single R&D license to a Vancouver Island corporation that promptly put the corp. for sale on E-bay for $1,000,000. HC never issued another R&D license after that. This was also apparently the reason for the delay from April 1st to June 19th. Anybody hear this too?
Sure nice to have a knowledgable person in the testing end of things. Do you have any qualifications too?
Waiting for a response from HC email asking them to have a look at our security plan. Estimated to cost under $9,000.oo for some major improvements to our antequated existing system. Including: 8 more cameras, vibration sensors for walls and windows(3), 16 channel brain to run all 12 cameras,2 electronic key fob locks with 24h monitoring, motion sensors and is mobile phone capable.
These do not seem that difficult to surmount, it's all in the procedures. I think that anybody that can run a successfull grow room can be the Quality Assurance Person. Your already doing just that, learn a few new steps in your already intense effort for quality. Mainly verification steps, it will be like wearing your helmet or fastening your seatbelt, after a while it will become second nature and you'll stop cursing the rules. Has anyone else started writing out procedures yet?
I heard a rumor, (firsthand), once removed, that I believe to be true for reasons I cannot divulge. (famous last words) I heard that HC did give a single R&D license to a Vancouver Island corporation that promptly put the corp. for sale on E-bay for $1,000,000. HC never issued another R&D license after that. This was also apparently the reason for the delay from April 1st to June 19th. Anybody hear this too?
Sure nice to have a knowledgable person in the testing end of things. Do you have any qualifications too?
Waiting for a response from HC email asking them to have a look at our security plan. Estimated to cost under $9,000.oo for some major improvements to our antequated existing system. Including: 8 more cameras, vibration sensors for walls and windows(3), 16 channel brain to run all 12 cameras,2 electronic key fob locks with 24h monitoring, motion sensors and is mobile phone capable.
Missbell81
Member
I've heard that the qcp doesn't necessarily have to be on sight and that samples could be sent away for assessment.
Kootenaygirl
Active Member
It 100% up to your local government, rdck, municipality, area, etc. to decide what works for their/your jurisdiction. The federal government has not stipulated. If your local gov. says residential is okay your good to go as long as it is not in a building where people live.