Change control

Any change in a process or a procedure must be formalized and controlled to identify, examine and approve its impact on quality. Planning, implementation, and evaluation of this change is done through a structured system for managing and tracking changes (change control management), one of four key components of a pharmaceutical quality system. A change is therefore voluntary and planned and destined to become permanent if its management and monitoring guarantees control.


Because undertaken in a coordinated, effective and timely manner, the change management system at Seratec, like control processes of the life cycle of changes, establishes the continuous improvement of our quality system. Innovation, the pursuit of excellence, continuous monitoring of our procedures and processes, product quality reviews (PQR), and the CAPAs, drive these changes. We control the different requirements in the change management processes and we make sure there is a high level of guarantee that unexpected consequences do not result from the change.


Our changes are indeed managed through a formal risk analysis to decide on the level of effort required. Similarly, the proposed changes are evaluated and tracked according to commitments and regulatory requirements, taking into account the information gained from product experiments, ideally from its design space and in applying quality risk analysis. In any situation we call upon our multidisciplinary team of experts to assess the proposed change and, once the change is implemented, we evaluate the impact of this change at the moment of its implementation.


This is a permanent control strategy to ensure the highest levels of quality, safety and effectiveness of our active pharmaceutical ingredients. This approach is initiated upstream in their design, continues in monitoring, action and reaction, and innovation, in all stages and processes of the product life cycle. It must lead to some regulatory flexibility.