Quality is the backbone of a pharmaceutical company and drives any activity in development, production, distribution and pharmacovigilance, required to ensure that a medicinal product is safe, effective and acceptable to patients.
To achieve and maintain high quality standards, a Quality System is in place, defining standards and internal rules commensurate with the complexity of the activities to be performed.
Any activity with impact on the quality of medicinal products is regulated by procedures, containing operating instructions to be followed in each of such activities. Personnel undergoes an intense and structured training program, in order to operate correctly and reach and maintain the established quality standards.
At the manufacturing sites, the Quality Assurance department is responsible for the overall Quality System and deals with its implementation, while the Quality Control department performs analyses on each batch of a medicinal product, and on each of its components, before its release on the market. To ensure a full compliance with the company Quality System, the engagement of all the staff at all levels within the company is of paramount importance.
Another important aspect of the Quality System is the control and traceability of the supply chain. This includes all the players involved in the production and distribution of the components used for the manufacturing of the medicinal products, as well as those involved in their distribution, once they leave the manufacturing sites. (To know more on quality activities see Menarini Pills of Quality).
Periodical assessments of the Quality System are performed through internal audits, product quality reviews and evaluation of quality indicators by the Company’s senior management.
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 use of digital technologies and data, as well their interconnection, will result in new activities or changes in the existing activities, as monitoring of process, controls and performance. The new manufacturing site’s design encompasses all the concepts of the digital transformation in technologies, process management, and people.