BETTER KNOWLEDGE FOR BETTER PROGRESS.

Knowledge management is commonly a multidisciplinary managerial approach that gives coherence to an organization and an optimal use of resources. As part of the development and manufacturing of active pharmaceutical ingredients, knowledge management, with quality risk analysis, facilitates the achievement of the strategic objectives of the pharmaceutical quality system which are: to ensure the realization of the product, to establish and maintain a control phase and to facilitate continuous improvement.

Knowledge of the product and the procedure must be mastered from product development up to the end of its marketing, inclusive. Knowledge management is defined in the ICH Q10 (Pharmaceutical Quality System) as “a systematic approach to acquire, analyze, store and disseminate information related to products, manufacturing procedures and components.”

In achieving the objectives of the quality system, facilitators can help distinguish, from all the knowledge gathered, that which is important but also that which is not.

In the development and continuous improvement of the product, information is generated that must be recorded in order to preserve its source data. It is often through written reports and laboratory notebooks, but the amount of data may require expert systems such as electronic systems for the collection of sources and electronic document management under the responsibility of an administrator.

Indeed, early in development it is important to establish the prior knowledge of the product and process gained by the researcher’s experience or training. An initial identification and risk assessment study provides an understanding of the product and the process and identification of the critical quality attributes of the materials which must be at an appropriate limit or interval to ensure their quality. Ideally this prior knowledge should prioritize the critical attributes to be evaluated.

In developing the process, work is undertaken to develop new scientific knowledge to establish risk control, meaning to be able to correlate in a “design space” the output objectives: the critical attributes of the API with input data: the quality attributes of the material and the critical parameters of the process.

After chemical development a scientific understanding of the materials and the process can be justified and initiate a thorough knowledge and a resulting “control strategy” to ensure their quality.

By 2008 Seratec had implemented digital technologies to manage and control the knowledge generated during collaborative development work, with problem solving tools and publication of scientific and technical information. More recently, GMP electronic systems, extended beyond simple quality management, were created to control documentation, workflows, procedures and processes.

Such an approach to knowledge management makes it possible to propose control of the life cycle of the product based on demonstrable scientific knowledge, and bring continuous improvement to the product life cycle.