we are SunLeaf Microcultivation Consulting
If you are a craft or ACMPR grower wishing to transition into the legal market, we can help!
We are focusing primarily on legacy growers who want to produce cannabis, legally. Our SunLeaf Microcultivation DIY SOP Kit -- which is a comprehensive EU-GMP Compliant Quality Management System (QMS) -- was designed specifically for our own Health Canada Microcultivation Application; it is NOT a set of SOPs for a Standard Licence, whittled down for a micro licence. The SunLeaf Cannabis QMS is the most streamlined set of procedures you can find to get in EU-GMP compliance and stay in compliance. Our SOPs read like a tutorial, so you learn about the regulatory requirements you must adhere to just by becoming familiar with the SOPs. And best of all, they are affordable to even the smallest mom and pop growers! SunLeaf is a Social Enterprise with a social contribution mandate that is as important as our bottom line. In an era of Vulture Capitalism, where every consultant seems out to get as much as they can whether the client can afford it or not, SunLeaf is dedicated to helping the industry, even if the caller is NOT a client. As such, Tamara Follett has spent countless hours on the phone with individuals and companies needing advice on what to do, or where to go, next. The first hour is free, and every hour beyond that is billed at just $65/hour, far below the $250/hour she charged as a Pharmaceutical Regulatory Compliance Subject Matter Expert before she retired. Drop us a line to let us know how we can help you!
If you are a Licencee preparing for an Inspection, or unhappy with your Inspection Report, we can help!
SunLeaf was the first licencee to uncover and publish the fact that --2 full years AFTER legalization-- Health Canada STILL does not have an approved published set of Inspection Guidelines for the Cannabis industry. They are using an unapproved, unpublished unavailable "working document", which they will not give the industry access to. But how can we be measured against standards we've never even seen? EVERY OTHER regulated industry has a set of approved published Inspection Guidelines available to them:
Why not Cannabis? Without published standards, there is no guideline for inspectors to follow, and no accountability if they make incorrect observations. Licence Holders who have gone through a virtual inspection are getting hit with Majors for outdated SOPs, and there are MISTAKES and ERRORS on the part of the inspectors that are not getting corrected, even when irrefutable proof is being supplied to the Enforcement Branch that the finding was incorrect. SunLeaf was successful in getting 3 Minor Observations and 1 Major Observation removed from their Inspection Report -- if you need help with contesting your Inspection Report, contact us!
Or, if you want a quick assessment of your Quality Records in preparation for your upcoming inspection, SunLeaf guarantees to find 3 to 5 issues that if left in place will produce a regulatory observation, or you get your audit for free! Contact us and ask about our Pre-Inspection Compliance Audit for the fee of $600. Call AS SOON as you are notified of your upcoming inspection, as it takes time to review your quality records and make necessary changes to your SOPs. A recent client was thrilled when his spotty record-keeping methods were whipped into shape by the time he got his inspection! Better still, he learned what the regulators are looking for and how to give them exactly what they asked for and no more. As a bonus, he learned how to complete his Quality Records accurately and thoroughly, so future inspections will be a breeze!
- Controlled Substances
- Clinical Trials
- Cells/Organs/Tissues
- Pharmacovigilance
Why not Cannabis? Without published standards, there is no guideline for inspectors to follow, and no accountability if they make incorrect observations. Licence Holders who have gone through a virtual inspection are getting hit with Majors for outdated SOPs, and there are MISTAKES and ERRORS on the part of the inspectors that are not getting corrected, even when irrefutable proof is being supplied to the Enforcement Branch that the finding was incorrect. SunLeaf was successful in getting 3 Minor Observations and 1 Major Observation removed from their Inspection Report -- if you need help with contesting your Inspection Report, contact us!
Or, if you want a quick assessment of your Quality Records in preparation for your upcoming inspection, SunLeaf guarantees to find 3 to 5 issues that if left in place will produce a regulatory observation, or you get your audit for free! Contact us and ask about our Pre-Inspection Compliance Audit for the fee of $600. Call AS SOON as you are notified of your upcoming inspection, as it takes time to review your quality records and make necessary changes to your SOPs. A recent client was thrilled when his spotty record-keeping methods were whipped into shape by the time he got his inspection! Better still, he learned what the regulators are looking for and how to give them exactly what they asked for and no more. As a bonus, he learned how to complete his Quality Records accurately and thoroughly, so future inspections will be a breeze!
announcing: the microcultivation diy sop kit is proven!!!
On September 13, 2019, we (SunLeaf Farmacy) received the 5th Micro Licence in Canada. To date, SunLeaf has helped over 50 microcultivators, microprocessors, standards, and nurseries obtain their licences, (including one EU-GMP Certified facility in Portugal!), with a number of additional clients in Final Review with Health Canada, now! In addition, at the 2020 Health Canada Regulatory Inspection of SunLeaf, the inspectors acknowledged that all the SOPs and Quality Records they were looking for were in place -- this means the DIY SOP Kit has been subjected to intense regulatory scrutiny and PASSED!
If your organization has already decided to apply for a micro-licence, or if you are still just thinking about it, please join our Facebook group where many of us have already submitted our applications. There is a great deal of important information being exchanged there every day about applying for a micro-licence, and the group is friendly and easy to ask questions. We highly recommend that you or someone in your company sign on to Facebook and request to be added to this group. There is no way to cover in phone calls/emails all the information being transferred in this group of highly knowledgeable thought leaders and subject-matter experts.
Click here to join our Facebook group: Canadian Cannabis Microcultivation
Click here to join our Facebook group: Canadian Cannabis Microcultivation
SunLeaf Microcultivation accomplishments:
- 50+ Licenced Micros to date
- A half-dozen more micros currently in Final Review with Health Canada.
- Fastest Path Through to Approval: 2 documented cases of 3 months from submission of Video Evidence Package to licencing.
- Most cost-effective path to licencing: entire application package is only $5000!
- The Microcultivation DIY SOP Kit is so thorough and complete, an EU-GMP Certified standard licence holder in Europe, one in New Zealand, and one in Canada are also using the GMP Quality Management System built-in to the SOP Kit.
- The ONLY consultancy offering to create anything Health Canada requests that isn't already in the kit, at no extra charge.
- The only SOP Kit that is GMP-compliant, for those producers wishing to sell to the lucrative EU or emerging US markets.
CHECK OUT OUR NEWEST PRODUCT! ===> www.MakeAnythingAnEdible.ca
Micro-Licence DIY SOP Kit
Background: We submitted our MCL Application on Christmas Day 2018. We received verbal approval for our licence on July 19, 2019. What we are providing is the complete set of SOP's, work instructions, quality records, schedules, and plans that we used. You will need to treat them as a DIY Fill-in-the-blank SOP Kit...take out everything of ours and substitute in the info for your organization. For the 10 documents required by the CTLS, that won't take but a few hours. This will speed up the application process and position you high in the approval queue.
To see the quality of our work, we will be happy to send 2 .PDF files for your review: the GPP Report, (needed by the CTLS) and the Sanitation SOP, so you can see how detailed HC expects you to be on even a simple procedure. These examples are still proprietary intellectual property, though, so before we send them, you and your partners will need to sign a Non-Disclosure Agreement (NDA). |
Non-Disclosure Agreement
To complete the NDA, please provide us your full name, address, phone, email address, business name, and the names of your RP, QAP, Head of Security, and Master Grower, as they will need to sign it, too.
Once the signed NDA is returned, we send the example documents out. You can search the Canadian Cannabis Micro-Licences Facebook Group to read numerous testimonials for us -- just search on the group for "DIY SOP". STEPS FOR THE NDA: 1. Request an NDA. 2. Provide information requested. 3. When it arrives, print, sign, and scan (or photograph) the signed NDA. $. Return BOTH PAGES of the NDA to us. 4. We will send your 2 example documents right out. Click here to learn about some of the ADVANTAGES our DIY SOP Kit offers! |
How To Order SOPs
If you decide to proceed with purchasing the DIY SOP Kit, just let us know and we will send an invoice for $5,000. The invoice will have payments instructions; we only accept Email Money Transfer or PayPal at this time.
Upon receipt of payment in full, we send out the 100+ procedures, work instructions, quality records, logs, and plans (OVER 500 PAGES!) needed to get your business into compliance and -- if you follow our SOPs carefully-- keep you in compliance with industry and regulatory standards. Clients who have submitted using our SOPs have enjoyed rapid processing through the initial Health Canada screening process. One client was invoiced just 2 days after he submitted his application via the CTLS! ADDITIONAL SERVICES ARE AVAILABLE AT ADDITIONAL CHARGE. |
SunLeaf Farmacy
Mission Statement:
In our mission of Quality First, SunLeaf Farmacy is dedicated to providing potent, affordable sungrown cannabis to Canadians.
We have only a few select strains, grown by licenced craft growers strictly outside, pesticide free, watered using natural well water, harvested at its peak, slow-dried carefully and cured to maximize terpenes, cannabinoids, potency, and smoothness. In these pictures, you can see our process and the THC crystals forming on the sun leaves. We take pride in every step of our process and believe this shows in our end product. Our primary medicinal strain offers 18% - 22% THC and potent cannabinoids. PLEASE NOTE: per the Cannabis Act, we are offering cannabis sales ONLY to other Health Canada Licenced Buyers. GUARANTEED DELIVERY |