Meet Maria Moreno, Compliance & Business Director.

What is the role of the Quality function in the Seratec organization ?

It is a transverse role. At SERATEC, quality is not a goal, it is a driving force. The quality management system was developed and has been integrated into the company for over 15 years with reference to the requirements of Good Pharmaceutical Manufacturing Practice (GMP). This system is periodically evaluated by the US (US-FDA) and European (EMA or ANSM in France) health authorities. This quality policy guarantees the satisfaction of our Customers and continuous improvement of our organization in all phases of its activities. It involves the participation of all of our teams, and although costly in time and resources, it allows us to save time for our Customers. Our quality department is there to bridge the gap between the demands of our business and the integration of the active pharmaceutical ingredients (APIs) that we develop into all our activities of research, production and testing.

How do you support the teams in the implementation of good practices ?

Let’s talk about methods in fact…

Every step of the manufacturing uses safe and effective methods, the result of our experience, our analysis and our continuous monitoring. Yet they are subject to our constant questioning and evaluated in terms of quality risk to patient targets, facilities and environment.

All of our processes follow written procedures that scrupulously comply with good pharmaceutical manufacturing practices (GMP). This involves team work in training, evaluation, and
improvement of the skills of our employees and the implementation of quality management tools. Methods, analyses, qualifications, facilities … nothing is left to chance …

Our employees receive initial training in GMP and follow a specific training program to keep a step ahead of changes in  
regulations. In addition, the quality team is dedicated to compliance with health and safety standards in our workshops. The standards and regulations change constantly indeed. We, the quality department, are responsible for ensuring that they are properly understood and applied at Seratec. Continuous monitoring and proper impact analysis and corrective and preventive actions are essential when striving for excellence. Indeed, quality and excellence are the responsibility of every link in our company, at every moment and at every stage of the manufacturing process of our APIs.

How is your production site in the Cosmetic Valley participating in this Quality approach ?

Our presence in Eure et Loir places us at the heart of the French pharmaceutical business

Our production site, which dates from 2003, was designed from the outset to facilitate compliance with GMP and to serve our methods and our goals. Thus the workflows of our materials, of our staff and equipment were defined and quality risks were assessed, in order to ensure they are controlled. To do this, these risks are communicated and reviewed periodically. Thus our production workshops are regularly inspected by the health authorities.

Our presence in Eure et Loir places us at the heart of the French pharmaceutical business and education centers, one hour from Paris.

It is indeed important for our development to take advantage of this communications network that ties us as much to our suppliers as to our clientele which is mainly international …

Thanks to this location, we are also developing a skills network with certain companies in the sector, and are taking advantage of the local fabric offering us a pool of qualified staff.