The Vitry-sur-Seine site is a major bioproduction and R&D center. To strengthen its industrial capacity, ensure regulatory compliance and optimize its processes, strategic projects are being deployed in a demanding environment.
France
Health and life science
The SANOFI site in Vitry-sur-Seine plays an essential role in the production of biological drugs, covering both research, development and large-scale manufacturing. Through the CPV program (Vitry Production Center), the group pursues objectives of operational excellence, based on a set of large-scale projects: improving process quality (validation, cleaning, data integrity), strengthening operational safety and anticipating international regulatory changes (GMP, FDA, EMA).
This context implies a close synergy between different areas of expertise: quality assurance (QA), quality control (CQ), production and engineering. In a highly regulated environment, the traceability of actions, the management of documentation and the control of processes are decisive in maintaining a high level of compliance. Specialized stakeholders in biotechnology also support the implementation of new processes or the optimization of existing lines. Each stage of the program is part of a logic of continuous improvement, both to maintain the industrial pace and to guarantee patient safety. The projects carried out thus have a direct impact on the site's production capacity, its competitiveness and its reputation within the global pharmaceutical sector.
In a context of strong industrial activity, SANOFI needed to consolidate its quality system and accelerate its critical projects. The objective: to respect high compliance standards, to increase the flexibility of production and to reinforce the reliability of processes. The support of specialists in quality assurance, processes, quality control and engineering was essential to carry out various missions — from the treatment of deviations to technology transfers — while guaranteeing the continuity of production and industrial performance.
Secure GMP compliance for products intended for international markets.
Manage critical validations (cleaning, procedures, data integrity).
Optimizing the performance and reliability of biopharmaceutical processes.
Within the CPV program, the mobilized teams work on multiple aspects: management of deviations and CAPA, validation of cleaning and industrial transfers, or even support for documentation and engineering projects. Management is done in close collaboration with the various internal departments (production, QC, R&D, maintenance) in order to coordinate actions effectively. Regulatory constraints (GMP, FDA, EMA) require irreproachable traceability of operations, and the industrial dimension of the site requires rigorous management of each phase, from study to commissioning.
Coordinate quality, processes and engineering in a multi-business environment.
Integrate compliance issues from the design and validation phase.
Manage the increase in load of the site through an adaptable schedule and the training of teams.
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