High-performance documentation starting from development.
Within the meaning of ICH Q8, the product life cycle corresponds to all phases of the life of the product during initial development, during marketing, and until its production is stopped.”
ICH Q10 describes a pharmaceutical quality system model that can be applied to the whole life cycle of the product. Therefore, these guidelines go beyond the current requirements of GMPs which do not apply to the development stage of a product, and are still optional. Nevertheless, their application facilitates innovation and continuous improvement, as well as strengthening the link between pharmaceutical development activities and those of manufacturing.
A life cycle may describe a process, a procedure or a system to illustrate the criticality continuum of it.
The life cycle must indeed be understood as an iterative process combining product development and continuous improvement, combining parallel and sometimes consecutive activities. It is throughout this cycle that the concepts of systematic approach and scope of development are applied as a proactive approach based on science. Compliance with regulatory requirements and suitability with the intended use can thus be satisfied by adopting a life cycle approach.
To do this it is essential that the quality system is designed and organized following clear and structured documentation to facilitate its implementation through an understanding shared by all.
It is also essential that the documentation be sustainable by establishing rules and procedures that capture regulatory requirements, but must also reflect the requirements of each of the services involved in the processes and procedures of the life cycle of the product in order to certify that the objectives of the quality system have been attained and witness the reality.
Even more than the description of the quality system and management responsibilities, documentation is the medium of knowledge management (link) and it conveys the proof resulting from product development. It is also a tool of control of corrective and preventive actions (link) and change management (link). Lastly, it allows the monitoring of factors influencing the quality and communication of results as part of the continuous improvement of the processes and the product.
A thorough knowledge of systems, procedures and processes in product development, structured around an extended life cycle approach makes it possible to document, in a reasonable and science-based form, the control of APIs manufactured by Seratec. The complexity of the implementation is due to the fact that the development of an active ingredient is a slow and gradual process, and, we have seen, iterative. This is the case when the starting point is only a concept of a molecule, but also when changes are implemented for a variation (technology transfer, new manufacturer, …). Although such an approach requires a development and learning period, which is costly in time and resources, it allows Seratec to inexorably move towards excellence.