The cannabis industry in the pharmaceutical business

Detailed gowning process, tons of standard operating procedures, validation protocols, batch records review, lock rooms, washable walls, stainless steel equipment, strict change control process, validated computer systems, and the most important thing: the culture of doing things right the first time. For those who are aware of how a pharmaceutical industry looks like, this does not sound like a big deal. For many years, we have seen the development of heavy regulations that rules this business and how companies are always investing time and money to keep their processes running at its finest. Any small change, innovation or productivity initiative needs to be challenged by the GMPs (Good Manufacturing Practices). The Quality Assurance department is involved in practically all decisions and should be the one giving the necessary guidance of what the company can or cannot do in regards to process and product changes.

When we think about the cannabis industry, the million-dollar question that comes to mind is: Why some cannabis companies have not yet realized they should be, in fact, a legitimate pharmaceutical industry?

The number of cannabis industries that consider themselves 90% farm and 10% pharma are being gradually reduced, however, some of them do not seem to realize what it really means to be pharma and to follow the GMPs. Of course, each company has its own business plans and priorities, but it hurts when we see them making plans to conquer a market share in Europe or South America, and at the same time not giving the importance to the fact that these places will not accept products unless they are 100% manufactured under pharmaceutical standards. It hurts to see them talking about how they plan to have their GMP facilities, but are still struggling with some basic concepts of pharma processes, and what hurts, even more, is the fact that some executives and high-level managers are still simply ignoring the facts. They do not understand (or do not want to) why it is not possible to keep changing suppliers without impacting a stability study (if there is one), why they cannot validate the process in one facility and produce in another, or why they cannot change formulas or move a machine to a different room without a risk assessment. Cannabis products are giving a better quality of life to patients with serious diseases, and it must have, at least, a quality that is comparable to that of a pharmaceutical product.

It is not the objective here to get into the discussion of what technically is a medicine, a natural health product or a food product. We could spend hours talking about the different types of products and all the Good Manufacturing Practices risks involved in each of them.

Beyond the business strategies and GMPs, some cannabis companies apparently still do not understand the value of having a culture in the organisation to create total quality, and what the mindset of doing things right the first time can bring to their business. A simple miscommunication due to the lack of integrated systems, manual calculations or isolated decisions can cause the reprocessing or even the recall of an entire batch; a weak warehouse management system may lead to a depletion of packaging and raw material inventory, affecting the entire manufacturing cycle time. Non-standardized sampling, testing or labelling process can generate rework, delay in releasing the product and the addition of hidden production costs. These are some examples of unacceptable issues in a pharmaceutical environment, but we often see the cannabis industry treating them as ordinary things: “just relabel it”, “just dilute it again”, “just throw the packaging material in the trash and buy new ones”, “just get more samples and send to the lab to be retested”, “just count the inventory again”. Thus, productivity and profit margins decrease, resources and materials are wasted, and money flows through the drain.

 
Several of the struggles and risks that we see today can be easily avoided using good old allies of the pharmaceutical industry: SOPs, process validation, robust and validated software, risk assessment, and the list goes on…

The correct implementation and configuration of an ERP (Enterprise Resource Planning) with a pharmaceutical MES (Manufacturing Execution System) for example, brings incredible reliability to the process. Versions of artwork and packaging materials, expiration dates, the use of correct raw materials, potency calculations, and many other variables of the process will be automatically validated. Data integrity, traceability and GMP standards will be automatically guaranteed, and the operator will have the freedom to give more attention to the process, performing the activities in a more safe and productive way. A WMS (Warehouse Management System) can ensure the correct identification of materials and finished goods, guaranteeing that they will be stored under the correct conditions, assigned in the optimal sequence and ensuring the allocation and shipment of the correct product for the correct customer. Controlled and high value materials will be automatically tracked, guaranteeing transparency each time they are moved or used. The implementation of robust SOPs can bring more stability to the process, ensuring that everybody follows the same steps to execute their activities and no isolated decisions are being made. A performance monitoring system can support the execution in production lines, helping to identify and eliminate waste of time and materials, bringing manufacturing excellence, increasing production volume and reducing costs.

It is about time that the cannabis industry deep dives into the pharmaceutical way of doing things. This immersion will drastically increase quality, boosting consumer loyalty consequently. The adoption of pharmaceutical standards will also help to reduce the prejudice that still surrounds these type of products and show investors that this industry is seriously worried about using their resources in an efficient, sustainable and productive way. What at first can be seen by the producers as a “nice to have”, will soon turn into a “must have”.

The cannabis industry needs to understand that they are in the pharmaceutical, not in the agricultural business. Creating this mindset is not easy; however, there are consulting companies, software providers and specialists with the appropriate background, they are all capable to make this process much less painful and know how to put this puzzle together.

The patients expect and deserve the best quality, let’s not let them down.

Fuente: https://www.linkedin.com/pulse/cannabis-industry-needs-understand-pharmaceutical-correa-pmp-mba/

Rodrigo Correa, PMP, MBA

Project and Operations Manager.