The industry of medical cannabis keeps growing. And we’re at the point where legislation is starting to catch up with. In fact, we expect GMP compliance and certification to become standard, just like the other pharmaceutical sectors. That leaves us with one key point to address: risk management.
Managing the risks of Medical Cannabis manufacturing is still a challenge so, in this blog post, we’ll give you some tips that can help you. Let’s get into it!
Challenges of the Medical Cannabis Industry
There are many challenges surrounding the production of Medical Cannabis, but we thought of focusing on three of them.
Firstly, the volatility. As a manufacturer of Medical Cannabis, we’re sure you are aware that the regulations are ever-changing, which makes it important to stay informed about any updates as they come out.
Then, although many clinical studies are still in progress, the data regarding high-quality efficacy and safety is not available yet. This has created a challenge for regulators to define proper guidelines.
And finally, we couldn’t skip the negative stigma around medical cannabis. The process of overcoming the prejudice around the active substances of cannabis is taking more time than expected.
The one thing these challenges have in common is how intertwined they are with the application Risk Management. Which brings us to the next section.
Add some Quality Risk Management to your Medical Cannabis Manufacturing
Quality Risk Management is actually an opportunity. It helps you minimise inefficiencies, maximise outcomes and, most of all, reduce concerns around your production. Let’s see how.
It starts by giving you all the knowledge of your processes and products characteristics. And knowing yourself is the first step to self-improvement, right?
But then you also get peace of mind! Having an appropriate risk management allows your company to better prepare audits based on for GACP/GMP licensing. That’s it: it gives you full awareness of the applicable regulatory framework to your production.
If by now you’re not convinced that you need a Quality Risk Management in your production, there’s nothing we can do more. But if you are, please keep on reading!
Start by Assessing the Risks!
Your first stop in the implement Quality Risk Management is, unsurprisingly, Risk Assessments!
Risk Assessments not only are useful to analyse and evaluate possible associated risks, but they also can help you identifying hazards.
You start by assessing the risks for the patient in terms of impact and uncertainty. This means that, if you find something with a high level of impact and a high level of uncertainty, you should focus your attention on it. And, of course, this is an exercise you should do at every stage of your production!
And performing risk assessments can be challenging! So, it’s important to have the right methodology and tools to apply and adapt to every specific area. Let’s see some useful tools that can help you in your risk assessments:
- Failure Mode Effects Analysis (FMEA)
- Fault Tree Analysis (FTA)
- Hazard Operability Analysis (HAZOP)
- Preliminary Hazard Analysis (PHA)
To summarise, these tools are useful if you study your risks in a qualitative way. However, you must also know that some risks can be measurable, and for that, you need to use statistical tools.
Statistical Tools are Here for you!
Statistical tools can be a great support to your quality risk management. More than enabling effective data assessment, they can be a facilitator when it comes to more reliable decision-making. Some statistical tools are commonly used in industry, such as:
- Control charts
- Design of experiments (DOE)
- Histograms
- Process Capability Analysis
We can Help you Manage the Risks of Your Medical Cannabis Manufacturing
For almost two decades, we developed technology for the Pharmaceutical Industry. And so, we have now brought them to Medical Cannabis Industry. Also, our solutions will help you identify, quantify, and prioritise risks that help you build risk mitigation strategies for new and existing assets.
If you would like to know more about how can we help your company develop risk management strategies to your Medical Cannabis Manufacturing, don’t hesitate to contact us.
