The Quality is the pillar on which our Company relies and that guides all the activities during the development, production, distribution and pharmacovigilance phases, with the goal to assure the safety, efficacy and the patients appreciation of our pharmaceuticals.
To achieve and maintain high quality levels, a Quality System is operative and it defines requirements and internal rules which are appropriate to the activities complexity.
Any activity with an impact on pharmaceuticals quality is regulated by procedures containing the modality to perform all the activities which could have an impact on the product quality. All the personnel who perform activities related to the product quality (production, warehouse, quality control, quality assurance, engineering) are subjected to an intensive and structured training program, in order to be able to reach and maintain the agreed quality levels.
Within the production Sites, the Quality Assurance Department is responsible for the whole Quality System and for its correct application in each Department, while the Quality Control Department performs the analysis on each pharmaceutical lot and on each of its components prior to its release on the market. To assure a total compliance to the Company Quality System, it’s crucial to involve all the personnel, at all company levels.
Another important Quality System aspect is the control and traceability of the logistic chain. This includes all the operators involved in the production and distribution of the components used for the pharmaceuticals manufacture, and also the ones involved in the distribution of the pharmaceuticals themselves, once they leave the production Sites. (to learn more about the activities related to Quality, please see Menarini Pills of Quality).
The Quality System, moreover than the already stated checks, is periodically evaluated through internal inspections, product quality audits and evaluations from the Company Board and Quality Key performance indicators.
The ongoing digital transformation with the integration of advanced technology and digital systems is a challenge and an opportunity also for the Quality System Management. Acquisition of digital skills through trainings of the personnel is a prerequisite for the digital transformation. The interconnection between the digital technologies and data utilization will bring to a different management of the existing activities, like for the processes monitoring, controls and performances. The new Production Site design project encloses all the concepts of digital transformation, applying it not only to the technologies but also to the processes and personnel management.