NHP Consulting Inc. has helped all our client’s navigate through the murky waters during the process to become a licenced producer. Health Canada’s (HC) standards have changed drastically since the inception of the MMPR program and we are proud to boost we have never had an application rejected and currently have multiple clients in the final review phase with many expecting on-site inspections and licenses by the end of the year. We would like to share some critical in-sight towards the major reports within the application.
Section 10: Quality Assurance Pre-Licensing Report
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 regulatory requirements.
It’s important to understand HC cannot grant a licence until each section within the application is covered in full. Health Canada will compare the reports within the application to each application section under the MMPR to make sure nothing is missing. Section 10 of the application (sanitation program) should be prepared by someone with Good Manufacturing Practices (GMP) manufacturing experience, preferably in the pharmaceutical industry. It should be noted that Good Production Practices (GPP) for medical cannabis is very similar to GMP for pharmaceuticals.
Within the first section 10 report you have to explain to HC how your premises will be designed to prevent contamination of the medical cannabis. Your design must separate clean (growing rooms) versus dirty (general office space) areas. Within the clean areas (GPP areas) you must describe the materials of construction for the ceilings, walls and floors. Generally speaking all materials must be hard, impervious and capable of repeated cleaning without degradation. We have seen many LP’s that have used wood and soft plastics! These LP’s must have been licenced prior to the new standards and we have no doubt they are receiving warnings from HC about these materials of construction.
Now that the inner shell is described, we need to describe the logical flow of material and people. This will lower the chance of any mix-ups like mislabelling the supplier, brand name and lot of any plant. There must also be an explanation on how we intend to keep adequate space to inspect all plants and clean / maintain the equipment. Another critical step to prevent mix-ups is adequate separation (physical and electronic) of cannabis in quarantine, release and rejected locations.
The next step within the report is equipment cleaning and sanitation. We always like to describe the different categories of equipment including direct, in-direct and no product contact. Direct product contact equipment includes trimmers, pruners, bulk storage containers and primary containers used for packaging orders for registered clients. Because there is direct product contact, these pieces of equipment pose the greatest risk to contaminating the product. Indirect product contact would include measuring devices for nutrients. No product contact includes stainless steel tables and light hood reflectors. Equipment (like the walls and ceiling) also have to be made of hard, impervious materials like stainless steel or hard plastic. Equipment also has to be non-shedding (no flaking paint for instance).
Next comes utilities. Most applicant’s biggest utility will be the Heating, Ventilation and Air Conditioning (HVAC) system. High level the HVAC system will need to be equipped with data loggers which are calibrated to measure temperature and relative humidity. Some applicants will also have hydroponics, aeroponics or a semi-automated system (drip feed system) to feed the plants. These systems will need to be described in detail regarding its operation to ensure it’s not a source of contamination to the plants.
We need to keep the facility, equipment and utilities clean and sanitary and good working condition. HC will want a detailed description of how this will be accomplished, including how to clean, who is responsible and how this will be documented. One of the biggest phrases in Quality Assurance is “not documented, not done” meaning if you can’t prove that piece of shiny equipment was actually clean (even if you could eat off it) during an audit you will be cited.
Last but not least we usually submit 10 SOP’s with each submission to supplement this entire section. All in all for a facility with no fancy growing equipment, you should have around 40 SOP’s. Different consultants may break their SOP’s up differently, but SOPs that are too long or too short can be extremely inefficient. Generally an SOP 5-6 pages long is the right recipe for success. An SOP that is too long will be hard to follow and train people and an SOP that is too short is not efficient to follow, meaning you may need 3 SOP’s in front of you to complete one given task.
The last section of the report deals with personal protective equipment (PPE) health and hygiene. At minimum PPE includes a hair net, lab coat, gloves (especially if you are in contact with cannabis) and booties or dedicated GPP shoes. Health and hygiene includes no open wounds around cannabis, no eating in the GPP area, and generally no jewelry or make-up to help reduce the chance of extraneous substances or other forms of contamination making its way to the cannabis at any point during the process.
Description of the quality assurance person’s qualifications in respect of the proposed licensed activities and the requirements of the MMPR;
We usually treat this section like a check list. EVERY single element of every single section of applicable regulation in this part needs to be described in detail. The average report size is 14-15 pages in length. I’m going to come out and say this is my least favourite report to prepare and often I dream of taking a long walk off a short peer during this process. Most QA people we help find for our clients are from the food industry and a few from the pharmaceutical. If we chose a person from the food industry, we usually have to supplement their qualification with some training. Direct experience is the most important, followed by training and technical knowledge (BSc. For example).
An example of a QA person’s qualification for section 53 of the MMPR:
Does the proposed QA person have any experience taking samples or reviewing test results for any microbial or chemical contaminants? Any experience with method validation? Any experience with any of the eight publications, most notably USP or Ph.Eur.? Then comes the supplemental training. I usually train the potential QA person on the required finished product specification sheet for cannabis and high level method validation according to the ICH guidelines. We have been very successful with this approach.
Section 11: Record keeping
Detailed description of your proposed record keeping methods. Your proposed record keeping methods must comply with and will be evaluated for compliance with Part 6 of the MMPR.
Once again, we treat this section like a check list with examples (screenshots from software or examples of hard copies). In addition to the examples, a written explanation of compliance is required. A new requirement by HC for the record keeping report is section 102 as well, even though it falls outside Part 6 – Record Keeping by Licensed Producers of the MMPR. Any “gaps” in the software require examples of the hard copies (excel word format) you will put in place. Some software is designed for the MMPR (Ample Organics) and some is not (BioTrackTHC). NHP Consulting has been successful getting both licenced. Keeping this in mind no software can provide a complete response to this section alone and hard copies are always required.
Let’s use section 134 (receiving cannabis) of the MMPR (under record keeping) as an example. BioTrackTHC covers most of the requirements (validated using screenshots) except there is no place to enter the receiving address or a confirmation on the type of cannabis (dried, seeds or plants, intended use) being received. To adequately substantiate compliance during the receiving process then, you would have to enter some details of receiving in BiotrackTHC, then supplement the rest of the required data for receiving using a log (hard copy). Another example is section 143 (c) where we only submit hard copy cleaning logs from our Facility Sanitation SOP.
Contact us today to learn more about how NHP Consulting can help you achieve regulatory compliance in becoming a Health Canada licensed producer of medical marijuana in Canada.