OLD MOTHER SATIVA
Well-Known Member
"How do you mean it took Tweed 8 months?"
> substitute weeks for months
> substitute weeks for months
MMPR Grow op: Small Scale
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woodsmaneh!
Well-Known Member
I have to say your not correct in what a good consultant can do. I have seen some less than desirable work done by people who say they are consultants but you need to do your homework.
A good MMPR consultant will get your application through in record time if you have the right one. Remember this has been going on for 10 months now and HC knows who has been doing a good job of consulting so if your consultant is known by HC you have a leg up. (if you have been doing good work)
Every file I review has mistakes in it and if they are caught before your app goes in, you have a much cleaner app and you move faster through the processe.
I have advised companies on all aspects of staffing from growers to QAP's and found them the right people for them.
Having your municipality on side is nice to have but if you meet the zoning they have little say in it. I advise my clients to go where they are wanted and not fight City Hall.
Connections with the government trumps everything. YES it does and it helps to have lots of experience dealing in regulated industries.
Most of what is required is offered by a experienced MMPR consultant like me, but we are not all created equal and that is what you need to look for.
To be a good MMPR consultant you need a lot of skills and growing is just one of them and not the most important of them.
Lets face it the more you do something the better you should get at it. Getting MMPR contracts through the process is an art and not just the sum of it's parts, the right Consultant will save you time and money and get it done faster than doing it yourself. I live and breath MMPR everyday and night that's all I do full-time every day. I get better everyday because I learn something new everyday and that is creating value for my clients.
Anyone can send in a application and hope for the best, it could take you a year to get it done or six months that's up to you, but think of this, every month you have to deal with HC answering questions because you missed something cost you $$$$, if you have a good advisory it will save you $$$ and get you up and running faster, and after all that's what we all want to do.
When I first started doing MMPR work I was at the low end of the fee scale but as my knowledge has increased so have my fees. That is a reflection of the quality of my knowledge and my ability to get the job done.
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leaffan
Well-Known Member
I have no doubt you can submit a good application for a client.
If an applicant doesn't have the skills or time to submit a good application, then a consultant would be the way to go.
The point I was making is that the application is only one part of the equation.
You know as well as I do that there are "perfect" applications that have been submitted that are in HC "limboland". Why?
I do appreciate your input here.
I am interested in your growing (no pun intended) success in the MMPR consulting business. Can you share how many applications you have prepared that have gone all the way through ie that are now LPs?
If an applicant doesn't have the skills or time to submit a good application, then a consultant would be the way to go.
The point I was making is that the application is only one part of the equation.
You know as well as I do that there are "perfect" applications that have been submitted that are in HC "limboland". Why?
I do appreciate your input here.
I am interested in your growing (no pun intended) success in the MMPR consulting business. Can you share how many applications you have prepared that have gone all the way through ie that are now LPs?
I get that from reading their press releases from the time they had identified their site and received by-law support in the community, to when they submitted application, to when they received approval. I also presume the applied early on, before the huge cue in the works now.
I think you may have your dates confused, as from what I have seen, they only received official approval on January 28, 2014.
Hi Everyone,
I am currently in the stage of writing my Quality Assurance Report for my application. There seems to be a lot of material to cover and I believe this is one of if not the most important section of the application. I plan on being the QAP for our company. A bit of background, I hold a bachelors of science degree with a major in statistics. ( the method for most quality assurance practices) I have interned at a pharmaceutical company as a student. For the last 4 years I have been working in strategy design, implementation and quality assurance for adjudication strategies at a major bank. I understand at first it appears like two completely different industries but QC is similar for all industries.
There are a lot of companies willing to assist with this portion of the app. ie IQA solutions etc. Has anyone used any of them? Are you happy with the services they provided?
Also is anyone interested in a divide and conquer approach to this section please pm me or respond to this thread.
Of the top of my head the following topics must be covered.
Good Production Practices (GPP) requirements relating to the
1)premises
2)storage of dried marihuana
3)equipment
4)the sanitation program
5)standard operating procedures
6)recall of product
7) quality assurance personnel.
testing
There are more topics that need to be covered. In order for the app to go through this section must be perfect so it would be beneficial to work together.
Cheers
-K
I am currently in the stage of writing my Quality Assurance Report for my application. There seems to be a lot of material to cover and I believe this is one of if not the most important section of the application. I plan on being the QAP for our company. A bit of background, I hold a bachelors of science degree with a major in statistics. ( the method for most quality assurance practices) I have interned at a pharmaceutical company as a student. For the last 4 years I have been working in strategy design, implementation and quality assurance for adjudication strategies at a major bank. I understand at first it appears like two completely different industries but QC is similar for all industries.
There are a lot of companies willing to assist with this portion of the app. ie IQA solutions etc. Has anyone used any of them? Are you happy with the services they provided?
Also is anyone interested in a divide and conquer approach to this section please pm me or respond to this thread.
Of the top of my head the following topics must be covered.
Good Production Practices (GPP) requirements relating to the
1)premises
2)storage of dried marihuana
3)equipment
4)the sanitation program
5)standard operating procedures
6)recall of product
7) quality assurance personnel.
testing There are more topics that need to be covered. In order for the app to go through this section must be perfect so it would be beneficial to work together.
Cheers
-K
Agracan
Well-Known Member
Glad you are taking the plunge. I can tell you about what we have in house so you have some idea of how others are going about it. (Perhaps someone else can chime in about their stuff).
Our QAP is an in house staff member with a masters in microbiology. With years upon years of laboratory qap experiance. We actually lucked out with her as she's done it all before albeit not in the cannabis industry.
In terms of SOP's or GPP we have a fat looking set of documents running on 200 pages that cover everything from mmj handling to reagent spillage.
I suggest you make the sop as clear and complete as possible as it will make your and your employees lives a lot easier once your up and running. If there are any questions they simply flip to the appropriate chapter and voila.
Again some here may say we went a bit overboard but in my personal opinion I like to be prepared for the unexpected.
Our QAP is an in house staff member with a masters in microbiology. With years upon years of laboratory qap experiance. We actually lucked out with her as she's done it all before albeit not in the cannabis industry.
In terms of SOP's or GPP we have a fat looking set of documents running on 200 pages that cover everything from mmj handling to reagent spillage.
I suggest you make the sop as clear and complete as possible as it will make your and your employees lives a lot easier once your up and running. If there are any questions they simply flip to the appropriate chapter and voila.
Again some here may say we went a bit overboard but in my personal opinion I like to be prepared for the unexpected.
Hi Agracan,
Thanks for the response. Saying you lucked out QAP is an understatement. I very much agree with your approach of being as detailed as possible. At the moment Im writing the GPP portion regarding the building. Is it enough to describe each portion of our unit and how it relates to production, or did you go further and describe the process as well?
Also which province are you located in?
Thanks in advance
-Konrad
Thanks for the response. Saying you lucked out QAP is an understatement. I very much agree with your approach of being as detailed as possible. At the moment Im writing the GPP portion regarding the building. Is it enough to describe each portion of our unit and how it relates to production, or did you go further and describe the process as well?
Also which province are you located in?
Thanks in advance
-Konrad
Green Medical
Active Member
Agracan
Well-Known Member
Konrad,
We're in Ontario. You basically do not need to give them the everyday lifecycle of the plant. What they want to see rather is that you know what you are doing, and that you will follow the provisions of the MMPR and your procedures prevent the endangerment of health of your employees and clients. Just remember your GPP and SOP are a living document, so whatever you write now and submit to HC, can and will be updated, upgraded as you are in operation (so don't hung up on micro details). You will find more efficient ways of doing things, you will find that certain procedures do not work in real life as they do on paper so they will be scrapped and revised. This is all due to the fact that we are essentially creating this industry from scratch (on a strictly controlled level).
In time, as the industry stabilizes, there will come out a clear set of guidelines for people to follow. HC is also learning as they go along, its all very fluid at this time.
We're in Ontario. You basically do not need to give them the everyday lifecycle of the plant. What they want to see rather is that you know what you are doing, and that you will follow the provisions of the MMPR and your procedures prevent the endangerment of health of your employees and clients. Just remember your GPP and SOP are a living document, so whatever you write now and submit to HC, can and will be updated, upgraded as you are in operation (so don't hung up on micro details). You will find more efficient ways of doing things, you will find that certain procedures do not work in real life as they do on paper so they will be scrapped and revised. This is all due to the fact that we are essentially creating this industry from scratch (on a strictly controlled level).
In time, as the industry stabilizes, there will come out a clear set of guidelines for people to follow. HC is also learning as they go along, its all very fluid at this time.
Not really creating it from scratch. Most of the QA requirements are identical to any NHP, so the general steps involved are well worked out already. The biggest difference between this industry and any other NHP is security, which dosn't have too much impact on the QA side of things.
I would recommend that anyone writing a QAR look into the information available for NHPs in general; much of the MMPR has been taken almost verbatim.
I would recommend that anyone writing a QAR look into the information available for NHPs in general; much of the MMPR has been taken almost verbatim.
Agracan
Well-Known Member
Yes I agree. Perhaps I should have said that we are creating a new cohesive industry rather than particular set of rules like GPP etc.
woodsmaneh!
Well-Known Member
Yes I do I have two
woodsmaneh!
Well-Known Member
I have one licensed, two waiting on inspections, 6 stuck in HC Hell, and preparing 3 to do in the next 1 to 3 months. I have three QAPs certified by HC on my team, and two labs I work with. I have one of the best Zoning Lawyers in the country on retainer. I also am about to get my build letter and have a 40,000 sq. foot building we own. I am starting with a small scale operation that will scale up to 40,000 in four years.
Most of my clients come to me after they get a couple letters from HC and they don't know what to answer or HC just keeps saying try again please. Kind of like roll up the rim. All this takes time and time is money. Waiting for HC to call is very expensive, most small producers are losing 120,ooo$ a month in lost revenue and paying $$ on the 100,000s of thousands they begged, borrowed and stole. So if you just have to get it done they call me. pipedreemz at hushmail dot com
You know as well as I do that there are "perfect" applications that have been submitted that are in HC "limboland". Why?
Yes there are near perfect apps stuck in HC Hell if I knew how to un-stick them I would. In fact I am working on high level contacts at HC which can shed some light on why? If and when they get around to talking to woods I'll let everyone know what happens.
keep the faith and keep moving forward.
woodsmaneh!
Well-Known Member
Hi Everyone,
I am currently in the stage of writing my Quality Assurance Report for my application. There seems to be a lot of material to cover and I believe this is one of if not the most important section of the application. I plan on being the QAP for our company. A bit of background, I hold a bachelors of science degree with a major in statistics. ( the method for most quality assurance practices) I have interned at a pharmaceutical company as a student. For the last 4 years I have been working in strategy design, implementation and quality assurance for adjudication strategies at a major bank. I understand at first it appears like two completely different industries but QC is similar for all industries.
There are a lot of companies willing to assist with this portion of the app. ie IQA solutions etc. Has anyone used any of them? Are you happy with the services they provided?
Also is anyone interested in a divide and conquer approach to this section please pm me or respond to this thread.
Of the top of my head the following topics must be covered.
Good Production Practices (GPP) requirements relating to the
1)premises
2)storage of dried marihuana
3)equipment
4)the sanitation program
5)standard operating procedures
6)recall of product
7) quality assurance personnel.
There are more topics that need to be covered. In order for the app to go through this section must be perfect so it would be beneficial to work together.
Cheers
-K
Here you go right from the horses mouth I have 10 different letters like this on QA from HC that I have answered for clients. If you want to write an answer to this letter I'll tell you how you did when you post it. Or maybe I'll just post another HC letter telling you what you wrote is still not good enough. Never give up, always move forward...Hi Everyone,
I am currently in the stage of writing my Quality Assurance Report for my application. There seems to be a lot of material to cover and I believe this is one of if not the most important section of the application. I plan on being the QAP for our company. A bit of background, I hold a bachelors of science degree with a major in statistics. ( the method for most quality assurance practices) I have interned at a pharmaceutical company as a student. For the last 4 years I have been working in strategy design, implementation and quality assurance for adjudication strategies at a major bank. I understand at first it appears like two completely different industries but QC is similar for all industries.
There are a lot of companies willing to assist with this portion of the app. ie IQA solutions etc. Has anyone used any of them? Are you happy with the services they provided?
Also is anyone interested in a divide and conquer approach to this section please pm me or respond to this thread.
Of the top of my head the following topics must be covered.
Good Production Practices (GPP) requirements relating to the
1)premises
2)storage of dried marihuana
3)equipment
4)the sanitation program
5)standard operating procedures
6)recall of product
7) quality assurance personnel.
There are more topics that need to be covered. In order for the app to go through this section must be perfect so it would be beneficial to work together.
Cheers
-K
hello,
Following a preliminary review of file 10-MM0000, it has been determined that the proposed Quality Assurance person does not meet the requirements of the Marihuana for Medical Purposes Regulations(MMPR). The training, experience and technical knowledge of John Doe are not sufficient to demonstrate compliance with Division 4 of the MMPR.
Please submit a more detailed description of the training, experience and technical knowledge of the proposed quality assurance person or submit an alternate proposed Quality Assurance person, and include a detailed description of the person's training, experience and technical knowledge relating to the activity conducted and the requirements of Division 4. If you are submitting an alternate Quality Assurance person, please also submit a new quality assurance pre-licensing report, signed and dated by the new Quality Assurance person.
The information requested must be submitted by April 2, 2014. If you do not respond by this date the Minister must refuse to issue a producer's licence pursuant to section 26 of the MMPR and your file will be closed.
Licences and Permits DivisionOffice of Controlled SubstancesHealth Canada
By the way your bank QA is worth nothing here. Nice try but not going to fly at HC. Now if it were GMP or GAP or HACCP or well you get the idea.
woodsmaneh!
Well-Known Member
SOPs, pictures are better than words, short is better than long (most should be 1 page or two at most.), plain english, large print, make them our own, they do change, just send HC a sample or two of your SOP's.
Remember never call HC always use Email, calls never happened and the most junior people work the phones.
Reply as fast as you can to their letters.
Here is a sample
TweedMart Cannabis Company
Personal Hygiene
Standard Operating Procedures (SOP)
PURPOSE: To prevent contamination of Medical Marijuana (MM) by CCMed employees.
SCOPE: This procedure applies to CCMed employees who handle and prepare Medical Marijuana.
KEY WORDS: Personal Hygiene, Cross-Contamination, Contamination
INSTRUCTIONS:
1. Train employees on using the procedures in this SOP.
2. Follow Health Canada department requirements.
3. Follow the Employee Health Policy. (Employee health policy is not included in this resource.)
4. Report to work in good health, clean, and dressed in clean attire.
5. Change work clothing when it becomes soiled.
6. Wash hands properly, frequently, and at the appropriate times.
7. Keep fingernails trimmed, filed, and maintained so that the edges are cleanable and not rough.
8. Avoid wearing artificial fingernails and fingernail polish.
9. Wear single-use gloves if artificial fingernails or fingernail polish are worn.
10. Do not wear any jewelry except for a plain ring such as a wedding band.
11. Treat and bandage wounds and sores immediately. When hands are bandaged, single-use gloves must be worn.
12. Cover a lesion containing pus with a bandage. If the lesion is on a hand or wrist, cover with an impermeable cover such as a finger cot or stall and a single-use glove.
13. Eat, drink, use tobacco, or chew gum only in designated break areas where product or contact surfaces may not become contaminated. .
14. Wear suitable and effective hair restraints while in the working and prep areas.
MONITORING:
CORRECTIVE ACTION:
1. Retrain any employee found not following the procedures in this SOP.
2. Discard affected product.
VERIFICATION AND RECORD KEEPING:
The Operations manager will verify that employees are following this SOP by visually observing the employees during all hours of operation. The Operations manager will complete the Safety Checklist daily. Employees will record any discarded Product on the Damaged or Discarded Product Log. The Safety Checklist and Damaged or Discarded Product Logs are to be kept on file for a minimum of 2 years.
DATE IMPLEMENTED: __________________ BY: _______________________
DATE REVIEWED: _____________________BY: _______________________
DATE REVISED: _______________________ BY: _______________________
Remember never call HC always use Email, calls never happened and the most junior people work the phones.
Reply as fast as you can to their letters.
Here is a sample
TweedMart Cannabis Company
Personal Hygiene
Standard Operating Procedures (SOP)
PURPOSE: To prevent contamination of Medical Marijuana (MM) by CCMed employees.
SCOPE: This procedure applies to CCMed employees who handle and prepare Medical Marijuana.
KEY WORDS: Personal Hygiene, Cross-Contamination, Contamination
INSTRUCTIONS:
1. Train employees on using the procedures in this SOP.
2. Follow Health Canada department requirements.
3. Follow the Employee Health Policy. (Employee health policy is not included in this resource.)
4. Report to work in good health, clean, and dressed in clean attire.
5. Change work clothing when it becomes soiled.
6. Wash hands properly, frequently, and at the appropriate times.
7. Keep fingernails trimmed, filed, and maintained so that the edges are cleanable and not rough.
8. Avoid wearing artificial fingernails and fingernail polish.
9. Wear single-use gloves if artificial fingernails or fingernail polish are worn.
10. Do not wear any jewelry except for a plain ring such as a wedding band.
11. Treat and bandage wounds and sores immediately. When hands are bandaged, single-use gloves must be worn.
12. Cover a lesion containing pus with a bandage. If the lesion is on a hand or wrist, cover with an impermeable cover such as a finger cot or stall and a single-use glove.
13. Eat, drink, use tobacco, or chew gum only in designated break areas where product or contact surfaces may not become contaminated. .
14. Wear suitable and effective hair restraints while in the working and prep areas.
MONITORING:
- A designated employee will inspect employees when they report to work to be sure that each employee is following this SOP.
- The designated employee will monitor that all employees are adhering to the personal hygiene policy during all hours of operation.
CORRECTIVE ACTION:
1. Retrain any employee found not following the procedures in this SOP.
2. Discard affected product.
VERIFICATION AND RECORD KEEPING:
The Operations manager will verify that employees are following this SOP by visually observing the employees during all hours of operation. The Operations manager will complete the Safety Checklist daily. Employees will record any discarded Product on the Damaged or Discarded Product Log. The Safety Checklist and Damaged or Discarded Product Logs are to be kept on file for a minimum of 2 years.
DATE IMPLEMENTED: __________________ BY: _______________________
DATE REVIEWED: _____________________BY: _______________________
DATE REVISED: _______________________ BY: _______________________
woodsmaneh!
Well-Known Member
the following Canadian acts and regulations and applicable sections of them apply to medical marijuana producers
Marihuana for Medical Purposes (MMPR) (introduced June 19, 2013)
Food and Drug Act (FDA)
Controlled Drugs and Substances Act (CDSA)
Food and Drug Regulations (FDR)
Natural Health Product Regulations (NHPR)
Narcotic Control Regulations (NCR)
Pest Control Products Act (PCA)
Under MMPR, licensed marijuana producers must also abide by standards set in Good Manufacturing Practices (GMP), ensuring a controlled, procedure-driven cultivation, processing and testing systems. For instance, if a question of safety or potency is raised, a licensed, GMP-compliant grower should be able to fully trace a specific product or dose, and answer concisely to the medical community and patients. (think recall)
Marihuana for Medical Purposes (MMPR) (introduced June 19, 2013)
Food and Drug Act (FDA)
Controlled Drugs and Substances Act (CDSA)
Food and Drug Regulations (FDR)
Natural Health Product Regulations (NHPR)
Narcotic Control Regulations (NCR)
Pest Control Products Act (PCA)
Under MMPR, licensed marijuana producers must also abide by standards set in Good Manufacturing Practices (GMP), ensuring a controlled, procedure-driven cultivation, processing and testing systems. For instance, if a question of safety or potency is raised, a licensed, GMP-compliant grower should be able to fully trace a specific product or dose, and answer concisely to the medical community and patients. (think recall)