Quality at Seratec plays a crucial, cross-functional role. For us, quality isn’t just a goal—it’s a driving force behind everything we do. Our quality management system has been deeply integrated into the company for over 15 years, aligning with the strict requirements of Good Pharmaceutical Manufacturing Practice (GMP). This system undergoes regular evaluations by health authorities such as the US FDA and European agencies like EMA and ANSM in France.
Our commitment to quality ensures customer satisfaction and fosters continuous improvement across all phases of our activities. Although maintaining this level of quality demands significant time and resources, it ultimately allows us to save time for our customers. Our quality department is vital in bridging the gap between our business needs and the seamless integration of the active pharmaceutical ingredients (APIs) we develop into our research, production, and testing activities.
Each stage of our manufacturing process is guided by safe and effective methods, which are the result of our extensive experience, thorough analysis, and ongoing monitoring. However, we constantly re-evaluate these methods to assess quality risks related to patient safety, facilities, and the environment.
All of our processes are governed by detailed written procedures that strictly adhere to GMP standards. This requires a collaborative effort in training, evaluating, and enhancing the skills of our employees, as well as implementing quality management tools. Nothing is left to chance—every method, analysis, qualification, and facility is carefully considered.
Our employees undergo initial GMP training and follow a specialized training program to stay ahead of regulatory changes. Additionally, our quality team is dedicated to ensuring compliance with health and safety standards in our workshops. Given the constantly evolving nature of these standards and regulations, our quality department is responsible for ensuring they are fully understood and correctly applied at Seratec.
Continuous monitoring, impact analysis, and the implementation of corrective and preventive actions are essential to our pursuit of excellence. Indeed, maintaining quality and achieving excellence is a responsibility shared by every member of our company, at every moment and in every stage of the API manufacturing process.
How is your production site in the Cosmetic Valley participating in this Quality approach?
Our production site, established in 2003, was designed from the very beginning to support compliance with GMP and to align with our methods and goals. The workflows for materials, staff, and equipment were carefully defined, and quality risks were thoroughly assessed to ensure effective control. These risks are communicated and reviewed regularly, and our production workshops are routinely inspected by health authorities.
Being located in Eure-et-Loir places us at the heart of the French pharmaceutical industry and close to educational centres, just an hour from Paris. This strategic location enhances our development by connecting us to a robust communication network that links us to our suppliers and our primarily international clientele.
Thanks to our location, we’re also able to develop a skills network by collaborating with other companies in the sector and drawing from the local talent pool, which offers a wealth of qualified staff.
The Pharmaceutical Quality System (PQS) is a management framework ensuring consistent production of high-quality products.
Seratec's strength is our deep understanding of operations and the pharmaceutical industry, setting us apart in a competitive market.
At Seratec, our expertise begins with the molecule and extends all the way to the active pharmaceutical ingredient (API).