MMPR Grow op: Small Scale

[Agracan]

Yup, this will f-up a lot of smaller LP's, who don't have huge amounts of spare cash lying around for full time QA's. The initial MMPR assessment before MMPR went into effect talked about how this whole new system is designed with small business in mind, i guess that idea is taking it up the *ss.This is really becoming a pay to play business.

 

[woodsmaneh!]

If anyone is caught in this jam, pm me and I'll help you out with some strategies and possible answers for you. Check back on some of my posts for my email.

Woods

 

[WHATFG]

Yup, this will f-up a lot of smaller LP's, who don't have huge amounts of spare cash lying around for full time QA's. The initial MMPR assessment before MMPR went into effect talked about how this whole new system is designed with small business in mind, i guess that idea is taking it up the *ss.This is really becoming a pay to play business.

Always was meant to be a big guys game. I do think they will allow a token number of small scale producers though.

 

[woodsmaneh!]

I'm counting on it. If anyone is thinking about putting in an application get "R" Done, HC will likely announce a closure on apps real soon. It takes 4 to 8 weeks to get it done if you know what your doing. Good luck all.

 

[WHATFG]

I'm counting on it. If anyone is thinking about putting in an application get "R" Done, HC will likely announce a closure on apps real soon. It takes 4 to 8 weeks to get it done if you know what your doing. Good luck all.

And I thought there weren't going to be any limits? I guess the big players are all in the loop leaving small scale producers.....where? Interesting...HC obviously didn't expect this kind of interest in such a new industry.

 

[Northernboyz]

I'm counting on it. If anyone is thinking about putting in an application get "R" Done, HC will likely announce a closure on apps real soon. It takes 4 to 8 weeks to get it done if you know what your doing. Good luck all.

I think I sent you a private post but would love to talk about this with someone that clearly understands the sort of resume that will pass HC's expectations. we have the smallest proposed site that we have heard about but would grow as the market (and HC) allowed. The idea that we would need a full time QA is simply unreasonable but at the same time HC has made it clear that that an exclusive person be attached to one only application.
HC wants to have someone scrutinize the first batches and SOP, and in light of an immediate industry Recall it's hard to blame them, so the employment contract will certainly be front loaded but eventually the demands on this person's time will be relative to production capacity. If a full time QA is required, it will immediately increase the required scope of LP's so they can absorb such a potentially weighty overhead and we may have to ramp our scope up considerably.

We are really interested in working with someone (preferably a retired inspector!) who is living in northern bc and would like to participate in our application and process and end up with a great long term part time job with upside. Anyone have a list of names??

 

[Devil Lettuce]

I think I sent you a private post but would love to talk about this with someone that clearly understands the sort of resume that will pass HC's expectations. we have the smallest proposed site that we have heard about but would grow as the market (and HC) allowed. The idea that we would need a full time QA is simply unreasonable but at the same time HC has made it clear that that an exclusive person be attached to one only application.
HC wants to have someone scrutinize the first batches and SOP, and in light of an immediate industry Recall it's hard to blame them, so the employment contract will certainly be front loaded but eventually the demands on this person's time will be relative to production capacity. If a full time QA is required, it will immediately increase the required scope of LP's so they can absorb such a potentially weighty overhead and we may have to ramp our scope up considerably.

We are really interested in working with someone (preferably a retired inspector!) who is living in northern bc and would like to participate in our application and process and end up with a great long term part time job with upside. Anyone have a list of names??

Hi NorthernBoyz,

As I mentioned earlier in this thread, I have been working in the QA sector for some time now. I'm sorry to be the bearer of bad news, but your assumption that HC will eventually let up and allow part-time QA personnel is incorrect. All other producers of consumables, whether that be food, water, herbs, pharma, are required to have a full time QA person, and LP's will have to play by the same rules. They want the QA person involved in all aspects of the grow to verify all procedures, SOPs and QAPs are being followed, and they also have to be available 100% of the time to receive, investigate, and handle customer complaints and any product recalls. HC has been explicit that these duties need to be carried out by the head QA person alone, so by definition the QA person must be a full-time employee. Just wanted to make that clear, you'd best be budgeting for a full-time qualified QA person for the duration of your operation.

Hope this helps clear things up for you.......even as a QA person myself, it took me some time to gather all of the info on what HC is requiring from the position. Good luck!

 

[leaffan]

Listen to the Devil, and like you say...ramp it up, or drop the dream.
After talking to so many people regarding the MMPR, the one common issue I see time after time is the ability of applicants to fool themselves. It doesn't matter what you think or what should seem fair. All that matters is what HC thinks and wants. The quicker you accept this the easier time you will have.
Good luck, leaf

 

[woodsmaneh!]

Hi NorthernBoyz,

As I mentioned earlier in this thread, I have been working in the QA sector for some time now. I'm sorry to be the bearer of bad news, but your assumption that HC will eventually let up and allow part-time QA personnel is incorrect. All other producers of consumables, whether that be food, water, herbs, pharma, are required to have a full time QA person, and LP's will have to play by the same rules. They want the QA person involved in all aspects of the grow to verify all procedures, SOPs and QAPs are being followed, and they also have to be available 100% of the time to receive, investigate, and handle customer complaints and any product recalls. HC has been explicit that these duties need to be carried out by the head QA person alone, so by definition the QA person must be a full-time employee. Just wanted to make that clear, you'd best be budgeting for a full-time qualified QA person for the duration of your operation.

Hope this helps clear things up for you.......even as a QA person myself, it took me some time to gather all of the info on what HC is requiring from the position.

Part time QA has been used in regulated industries for 50+ years, it is still used in many regulated industries, including Herbal Remedies, cosmetics, medical devices, pharmaceuticals and so on. I have a couple QA's that do just that and are moving into the cannabis field. HC has said for 10 months that PT QA is OK, as of Friday it is not allowed. That gives everyone 2 weeks to find a new full time QA or your application is rejected. Anyone know where we can find 140 full time QA's just to start? This is what it is thinning the herd.

The full time QA is just the first strike at the new industry by HC to thin the herd of 700. Wait for the other shoe to drop, it's coming.

Never forget the government does not want people to have access to Cannabis so any and every thing HC does is to that end. I find it very troubling and disturbing our government is dealing in bad faith.

 

[Devil Lettuce]

Part time QA has been used in regulated industries for 50+ years, it is still used in many regulated industries, including Herbal Remedies, cosmetics, medical devices, pharmaceuticals and so on. I have a couple QA's that do just that and are moving into the cannabis field. HC has said for 10 months that PT QA is OK, as of Friday it is not allowed. That gives everyone 2 weeks to find a new full time QA or your application is rejected. Anyone know where we can find 140 full time QA's just to start? This is what it is thinning the herd.

The full time QA is just the first strike at the new industry by HC to thin the herd of 700. Wait for the other shoe to drop, it's coming.

Never forget the government does not want people to have access to Cannabis so any and every thing HC does is to that end. I find it very troubling and disturbing our government is dealing in bad faith.

This is some great info.....I was unaware that HC was changing the rules on the fly. Great points on part-time QA being permitted in some other industry instances, however the QA person has added responsibilities under the MMPR that they would not have in other sectors. Also, in most of the instances mentioned, part-time QA's may be permitted for different production sites/facets of a production operation, but the company as a whole is required to have a dedicated manager/overseer of the company QA program. As far as I can tell from my gatherings, HC is looking at LP's much the same way they look at pharmaceutical producers.......I think prospective LP's should keep that in mind when planning an application, there aren't going to be any short-cuts or easy roads into this. All the i's have to be dotted and t's crossed before HC will consider approving any application.

I also think that if HC were to allow part-time QAs, that they would be sending entirely the wrong message to both LP's and to patients.......and that message would be that quality assurance is only a part-time job. I'm sure many patients would be outraged by that, and it would also be inviting LP's (big and small) to cut corners in the name of profits. We are in the business of producing medicine for the ill and suffering, so we can't cut corners in this regard. Allowing part time QA's would present LP's (and the industry as a whole) with much bigger headaches down the road, IMO.

Combining these factors with this being a fledgling industry, and Woodsman's excellent point about this being an easy way for HC to cull applicants, this was inevitable IMO. Very poor form on HC's part though, and not at all fair to anyone involved.

 

[ispice]

Just like to point out to devil license that one big difference with other similar industries QA regs and requirements, such as NHP and herbal remedies is that they do not include or cover the cultivation of the substance. They have GMP not GPP's the difference is huge, as one is for the Manufacturing the other is Production which includes all cultivation aspects.
What QA person is has experience or training involving the QA of cultivating a plant on an industrial or small scale? Very few, only those who have extensive formal QA experience as well as extensive cannabis cultivation experience would be actually considered qualified, of which there are probably 10 in the country at most.

The QA is traditionally responsible for the manufacturing and processing part of the operation, of which there is really none allowed or required under the MMPR, you can sell a raw untouched product, the only processing is drying and packaging(sometimes trimming if desired) the QA report involved for that could never cover 150 pages. The important part for the QA is to understand and act regarding the analytical and adverse reaction reporting end of things. If they can interpret lab data and are competent in record keeping and the MMPR requirements then they should be acceptable, its not up to them to make sure the cultivation is done properly, its up to them to make sure the product that gets sold or provided passes the reg requirements which are basically the contam detection and limits. Most labs will provide a simple indication of pass or fail based on the requirements and limits they get from the pharmacopoeia, leaving it possible for a child to interpret the data.

How many SOP's are out there for growing crops, sure its not hard to write them, but who is formally qualified to do so for cannabis, and why should they have to deal with the cultivation side of things.

All that matters is what HC thinks and wants, but they do not even know what that is, they are inept, purposefully constructed or not it doesnt matter, what does is how it is affecting medical users and the future cannabis industry.

 

[Devil Lettuce]

Hi ispice, fantastic post! You are pretty much bang on with everything......the trouble is, much of that relies on logic and reason. Like you said, this is all that matters:

All that matters is what HC thinks and wants, but they do not even know what that is, they are inept, purposefully constructed or not it doesnt matter, what does is how it is affecting medical users and the future cannabis industry.

I have a lot of experience dealing with various government regulating bodies, so I was prepared for all the bureaucracy and red tape when I started looking into becoming an LP. The one thing I have tried to do the entire time is to think like Health Canada.......logic, reason, real-life experience, practicality, a zillion years of cannabis cultivating expertise, none of that matters. This is a big game, and we are all forced to play by Health Canada's rules (which are constantly changing). My posts regarding what will be needed in regards to QA is from HC's perspective and what will be needed to get approved, not necessarily what is reasonable given the experience and knowledge of most people looking to get into this industry.

LeafFan made a fantastic post today regarding prospective LP's 'fooling themselves' about what it will take to get approved......as we are all very passionate about this, so it is an easy trap to fall into. To have a serious shot, you need to throw ego out the window, think like the sadistic entity known as HC, and give them whatever they want. In this game you will have to lose a few battles in order to win the war and get approved.

 

[rnr]

I have a very high up friend working with HC and the system, his #s are
765 apps in so far,
360 withdrawn or rejected
405 to deal with
-??? to cut due to PT- QA
we will see.......

these #s are hear say to me, from a good source so dought them or whatever......

 

[Devil Lettuce]

I have a very high up friend working with HC and the system, his #s are
765 apps in so far,
360 withdrawn or rejected
405 to deal with
-??? to cut due to PT- QA
we will see.......

these #s are hear say to me, from a good source so dought them or whatever......

Very interesting, thanks for posting! Woodsmaneh also indicated that he thinks that HC is going to close the door on new applications soon, which is is the first I'd heard of that, so I'd love to hear more details on that front.

 

[woodsmaneh!]

Here is what HC says here.

Please note that we are still awaiting your response to the query posed below. We require this information in order to continue with the review process of your application.

The proposed quality assurance person must be able to conduct all activities as per Division 4 which includes understanding the analytical results performed to determine the level of microbial and chemical contaminants in the licensed producer's dried marihuana product in order to assure it's quality before it is available for sale. Also, the quality assurance person must be able to understand how to validate methods as required by sections 53(2) and 54(2) of the MMPR. Plus, the quality assurance person must be able to ensure that the equipment, premises, and sanitation program are accurately followed and that the licensed producer's procedure are meeting the requirement of the MMPR as per sections 55, 56, and 57 of the MMPR.

It is important to provide as much details as possible when describing the proposed quality assurance person to demonstrate that the chosen quality assurance person has the proper training, knowledge and technical expertise to conduct this mandate. Please note that Health Canada does not have provide recommendations for quality assurance training. It is on the onus of the licensed producer to demonstrate that the selected quality assurance person is qualified and will be able to conduct their duties as listed under Division 4 of the MMPR.

Please note that the quality assurance person must be able to investigate any complaints received by the licensed producer. If you decide to have a quality assurance person who is only available part-time, you will need to demonstrate in your application how the quality assurance person will be able to investigate complaints in a timely manner, if any complaints are received by the licensed producer. Additionally, if a recall is executed, the quality assurance person is responsible for conducting the recall and will need to advise the Minister on the reason for commencing it. This responsibility requires detailed verifications and a clear understanding of all aspects of Division 4 of the MMPR.

As a reminder, the duties of the quality assurance person are to ensure that the quality of the products at all steps of the production process and to certify that all processes were conducted as per Division 4.

and what they say here, they toss in the whole process from seed! So now QA covers from seed to shipping? So what is it?

The quality assurance person that is designated under section 10 of the application cannot delegate any responsibilities under Division 4 to another individual. This person is responsible to ensure quality at all steps and must ensure that dried marihuana is produced, packaged, labelled and stored in accordance with the SOPs developed, using the proper equipment and within the sanitation program established and all items under Division 4.
Currently the proposed schedule for John Doe is unclear. Given that Mr. Doe is a Consultant, and that the production of marihuana usually extends over a long period of time from sowing of the seeds to drying the product and that production, packaging and labelling may be conducted on daily basis, your proposal still lacks in demonstrating how it will maintain the quality of all dried marihuana before it is made available for sale as per the requirements of Division 4 of the MMPR. Please submit a more detailed description of the work schedule of your quality assurance person to ensure that all steps detailed above will be sufficiently overseen by this person.
As per section 58 of the MMPR, dried marihuana must be produced, packaged, labelled and stored in accordance with standard operating procedures that are designed to ensure that those activities are conducted in accordance with the requirements of this Division. As per section 60, the quality of the product is the responsibility of the Quality Assurance person. Please confirm whether the quality assurance person is full-time or part-time and please provide additional information to demonstrate how they will be able to ensure the quality of the product at all steps.

 

[Devil Lettuce]

Thanks for this post Woods! This confirms my suspicions as to what HC is looking for from the QA individual, particularly the part about the requirement for them to be involved in overseeing all aspects of the grow, seed to sale.

 

[woodsmaneh!]

What I find interesting about all this is I have some very bright colleges who work in this area and yet they still get crap from HC. It's like just when you found the door in a dark room, HC moves it again. It's endless letters with no help in them at all. I have to give it to HC they sure are the kings of run around, persistence is the key to keep moving forward. Get your answers in fast and keep replying no matter what.

 

[Devil Lettuce]

What I find interesting about all this is I have some very bright colleges who work in this area and yet they still get crap from HC. It's like just when you found the door in a dark room, HC moves it again. It's endless letters with no help in them at all. I have to give it to HC they sure are the kings of run around, persistence is the key to keep moving forward. Get your answers in fast and keep replying no matter what.

Persistence is 100% going to be key in this. HC is counting on applicants giving up, and so are the mega-producers......I would not be surprised if HC is getting pressure from one or more of the giants to tighten up on the small-LP's.

 

[MMHot]

Reading all your posting for a long time. First time posting here!

On the QA aspect. HC is asking for many information on the QA person. From my experience, they want to check if my QA person is able to make everything as per their requirement. Which make sense. They don't do an exam on the person; they only evaluate according to what we write in the application. So basically, it is our job to write as much as possible to show that the person will be good for understanding the analytical testing, doing the SOPs, finding solution when issues comes up etc. I think HC is doing their very best and also they are evaluating as they go as well. Plus they told me, "each file is evaluated individually but we also look at the global picture". Which is a tool that we do not have since we only know our own application.

As for me, they said a QA person can be part-time. However, a QA person cannot be for more then one site.

Which make a lot of sense also. How could a QA person be at two site at the same time if I need him I want him available and ready to come quickly. Plus the QA person is the one like you said that needs to do all the check from the seeds to the shipping. Cheers!

 

[Devil Lettuce]

Reading all your posting for a long time. First time posting here!

On the QA aspect. HC is asking for many information on the QA person. From my experience, they want to check if my QA person is able to make everything as per their requirement. Which make sense. They don't do an exam on the person; they only evaluate according to what we write in the application. So basically, it is our job to write as much as possible to show that the person will be good for understanding the analytical testing, doing the SOPs, finding solution when issues comes up etc. I think HC is doing their very best and also they are evaluating as they go as well. Plus they told me, "each file is evaluated individually but we also look at the global picture". Which is a tool that we do not have since we only know our own application.

As for me, they said a QA person can be part-time. However, a QA person cannot be for more then one site.

Which make a lot of sense also. How could a QA person be at two site at the same time if I need him I want him available and ready to come quickly. Plus the QA person is the one like you said that needs to do all the check from the seeds to the shipping. Cheers!

Hey MMHot, welcome to the thread! There is a ton of great info in here.

You may want to check back with HC or wait for some correspondence this week......Woods had been looking after the applications of a bunch of prospective LP's, so he has the latest info. Health Canada has just changed the rules on the fly.......originally they were allowing part-time QA's, but are now notifying all applicants that part-time QA's will not be permitted.