Authored By : Michael Sassano
Thankyou to our newest contributor Michael Sassano who will be penning a series of articles for us explaining GMP compliance.
If you are a North American company wishing to do business in the EU, UK , Australia & NZ you will need to be, above all, GMP compliant otherwise you won’t even get past “GO”. Never mind all the other compliance issues you’ll need to deal with !
Here’s part 1
GMP SERIES #1: “Starting Your GMP Approval Process for Cannabis Correctly”
Co-Authored by: Michael Sassano and Antonio Guedelha PHD
Michael Sassano, CEO of Somai Pharmaceuticals (USA)
The path to facility and product approval in cannabis is a long road that requires attention to detail and proper knowledgeable people to guide the project from start to finish and beyond. There are different levels of GMP approvals, but our concentration will be on pharmaceutical manufacturing, food supplement manufacturing and grow side processing through the series. Keep in mind, GMP, or Good Manufacturing Processes, is are minimum standards set and approved by regulatory authorities to create uniformity of product production and to protect the consumers. In cannabis, we should always strive for higher quality to spread awareness, increase education and speed distribution of products to patients worldwide.
Choosing the Right Person for Cannabis Pharmaceutical Products and Food Supplements.
Pharmaceutical GMP certification is a much more demanding path. First, we must consider the project needs and necessary steps for getting your new facility FDA-GMP, or EU GMP approval. This starts from the beginning when choosing a location, then proceeds to layout, process equipment and ERP, all which must be integrated and aligned accordingly with GMP requests. You will need a person with experience in global management of pharmaceutical manufacturing facilities. One such person should also have experience supervising a process of building from start to finish, with GMP approval. The right person must have knowledge of the suppliers for each of the needs of the project. They must possess excellent know-how of manufacturing facility operation according to GMP. Make sure you also choose someone with experience in GMP inspection by authorities and has success in the approval processes. Autonomy and a solution oriented mindset are always solid qualities, with the power of decision and negotiation.
In terms of food supplements, requests are often less demanding. However, the market is starting to prefer food supplements produced in GMP facilities. The difference to pharmaceuticals is that the requests are less, so someone familiar with food processing can successfully integrate into the pharmaceutical setting.
Choosing the right person for cannabis farming
When it comes to cannabis processing GMP standards, the lines between GACP farming and GMP processing are blurring. One way to find a good consultant is to find a grow that has gone through the certification process and subcontract them. This is beneficial to both parties because it supplements the infrastructure costs, and they are already aware of regulatory restrictions and pitfalls.
The other way is to search through many consultants and talk to references that have achieved GMP certification. You must have definitive proof they have obtained a GACP certified grow and a GMP certified processing facility. They must also have real operating experience in an herbal grow facility. Furthermore, it’s in your best interest to check their quality of manual writing skills or if they are subcontracting that out, as this can add additional costs. Many large and small-scale subcontractors are also available and use various consultants to help write procedures and design buildings. However, this way, you are following rather than leading your business.
Products to be made and future plan
From day one, you need to understand the products you’re making as well as applicable categories and rules. We will get into this more in later articles, but start with a simplified approach. If you are growing, concentrate on cannabis getting from the grow to the processing facility, through the drying process, as well as registration and packaging. You may consider fresh frozen as a product, but this is still a grey zone due to water presence, so it will not meet GMP standards. Think linearly between dirty zones, clean zones and secondary packaging. The basic idea is to ensure paths are not crossedbetween cleanrooms (dry area to packaging) and dirty areas (where plants enter dry rooms).
Producing is more complex. Defining the products and the ones you may produce in the future is critical. The entire project will be based on these products and flows. This is the most difficult step, and many projects fail to pass this phase or end up with significant changes during execution, costing money and time. Keep it simple and start with the estimates of quantities to be produced at first of raw ingredients like distillate and then move to your end product formulation. One of the largest factors in design comes from dimensions of the process equipment, which defines the size of the rooms and ultimately the building. At the same time, many products with different manufacturing processes and equipment will require more rooms and more space. In order to avoid cross contamination results in additional rooms, install interlocks and different pressures between rooms and corridors. Keep an eye on the size of the facility to make the minimum production quantity that will make the manufacturing facility profitable.
Design
Once you have the process and products down, the design becomes all technical. Hire an architect with knowledge or ensure your consultant has the knowledge to guide your architect. Of course,the best solution would be to let your consultant maintain guidance with top tier operational experience as his knowledge is generally higher than the local architect. When it comes to growing, real world experience for throughputs and processes becomes very important. This should follow in line with the product not going backwards through the process to avoid cross-contamination. Remember: Products always enter one area and exit through another.
When it comes to pharmaceutical and food supplements, equipment and air-handling become much more complex.Clean-room technology specialists is a necessity. Food supplements requests from HACCP (Hazard Analysis Critical Control Points) are less demanding compared with pharmaceutical GMP. Today, HACCP is increasing the requests and merging in the direction ofGMP. However, the needs are different. Food is for all, but pharmaceutical products are for persons without good health, which means that they cannot bring new threats for this person. So pharmaceutical GMP regulations are always the highest standard.
In pharmaceuticals, processing equipment has additional standards and all parts must be cleanable so as to not release particles nor contaminate the product between runs. The layout of the pharmaceutical facility revolves around the product flows plus equipment, and together with the HVAC (Heat, Ventilation, and Air Condition) systems, these technologies can avoid cross contamination and assure the right temperature and humidity inside the rooms. There is also a need to define different pressures between rooms to avoid the passage of gases or particles from one room to the other. A well designed HVAC system together with the layout will allow you to decrease the energy consumption while avoiding contamination. And your choice of HVAC systems is important as they will use 70 – 80 % of the total electrical consumption.
These building blocks of getting the right people, understanding your products and designing for the future will send you on a solid path towards your goal of making a GMP approved cannabis facility. Keep in mind:
- Choose the right person
- Define products to be manufactured in the facility
- Decide if they will be food Supplements or pharmaceutical Products
- Prepare an estimate of the forecast for the next 5 years
- Define manufacturing processes
- Define process equipment size according to the quantities to be produced
- Define layout according to process equipment size
- Project HVAC system to minimize energy consumption
In the next series, we will go deeper into products and the various complexities for various cannabis products you may want to make. ….
