Interview with Massimiliano Zorzan, Head of Quality Assurance & Regulatory Affairs at SUANFARMA Italy

How does SUANFARMA Italia ensure that it delivers only the highest possible quality products? Massimiliano Zorzan, Head of Quality Assurance & Regulatory Affairs,
tells us about his role within the quality control process in this interview.

What is the difference between Quality Assurance and Quality Control?

Quality Control and Quality Assurance are like brother and sister.

Quality Control is curious and methodical and wants to control the quality of the product, it wants to know how it is made, i.e. how it is composed (how much active ingredient it contains, how many impurities, how much moisture, etc.) and verify that its characteristics are within the set limits.

Quality Assurance is accurate and systematic and wants to make sure of the quality of the product, it wants to know how it was made, i.e. if the process was done correctly, if the parameters respected the set limits and, if they didn’t, it wants to understand the cause to avoid the problem from occurring again.

It is important that both brother and sister agree that the product is of good quality, so that the material can be used or sold.

However, if at least one of the siblings has a problem, it is very likely that the material cannot be used or sold.

What does Regulatory Affairs do?

Regulatory Affairs is the cousin who studied law.

Regulatory Affairs is rigorous and formal, it knows all the laws and rules that must be respected in order to sell the product in the various world markets, it prepares all the documentation necessary for the product registration so that it can be commercialized and it keeps it updated with respect to all the changes made in the process.

Without Regulatory Affairs, the work of Quality Control and Quality Assurance would be in vain because the quality product could not be sold without the necessary authorization.


What personal characteristics are essential in your role?

I don’t think there are any particular personal characteristics to have, also because, being personal, everyone has their own. Everyone has a different approach to problem management and this is not necessarily a bad thing; on the contrary, it allows you to see nuances that might otherwise go unnoticed.

However, two things are essential: knowing the procedures well because they are the daily work tools and define the space within which we must operate and having a clear idea of the ultimate purpose of our work, which is to ensure the quality of the product, which is essential both for the reputation of the company and for the safety of the patient. We must always be clear in mind that ours is an ethical business.


What are the current trends in Quality Assurance?

A current theme is certainly the computerization of processes, not only production but also management. For some time now, electronics have been replacing paper, but the most interesting recent aspect is the interconnection between systems, for example between Production and Quality. This leads to two main advantages, the first is the guarantee of the traceability of the data and its integrity, the second is a greater automatism that significantly reduces the manuality of the processes. It must be kept in mind, however, that this does not necessarily mean a reduction in the human workload because it tends instead to shift it to other activities. In other words, if I automate a process through the use of software, fewer resources are needed to conduct the process itself, but more will be needed to manage the software that controls the process.


Three words to describe SUANFARMA

New, dynamic, enterprising


SUANFARMA, as we know it today, is a novelty born from the union of its historical commercial nature with the productive sphere.

For us at SUANFARMA Italia, who joined the group two years ago, the element of novelty lies in knowing and dealing with the commercial side of the business. A sector that was not previously present in our organization and with which we have to “synchronize” the timing of our processes.

On the other hand, for SUANFARMA the novelty lies in “synchronizing” the commercial needs with the typical timing of a production site.

SUANFARMA is dynamic.

Dynamism is intrinsic and functional to novelty, SUANFARMA is dynamic because it is evolving. I’m thinking, for example, of the new R&D department, new products in development and the search for other potentials, the search for new customers and markets, job rotation and new hires.

SUANFARMA is enterprising!

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