Un système qualité pharmaceutique (PQS) est un système de management pour diriger et contrôler une entreprise pharmaceutique en matière de qualité.
“A Pharmaceutical Quality System (PQS) is a management system to direct and control a pharmaceutical company in terms of quality.” This definition of ICH Q10 is based on the definition from the family of ISO 9000 standards, with the primary objective of ensuring the quality and efficacy of the medicinal product , and patient safety, while improving the overall level of quality and the performance of the business. The management system is based on prior establishment, throughout the life cycle of the pharmaceutical product, of a quality strategy to achieve these objectives (link 38- Management Responsibilities).
The quality system is the sixth central system at the service of an API that creates the foundations and orders the other five systems focused on pharmaceutical production (link 52- 6 systems …). These six systems in total, in their definitions and their inter-correlation, are the PQS. They interact with each other and depend on each other because they must work together to ensure a quality product. With this modern system approach, the PQS can implement the continuous improvement and focus efforts by managing quality risk.
Risk taking is an important element in the activity of entrepreneurs and their companies, especially for their profitability. In the pharmaceutical industry, risk taking is limited by a precautionary principle, that of patient safety. This industry is also highly regulated, with, at the forefront, good manufacturing practices that organize the requirements. A pharmaceutical quality system is based on these considerations by combining innovation and regulation to develop a robust and efficient way to reduce quality risk of and therefore improve the quality of the pharmaceutical product.
Specifically, the PQS is created, according to ICH Q10, of four elements that it is useful to apply consistently and commensurate with the life cycle:
- A performance monitoring system of the process and product quality; Intended to demonstrate control and identify potential areas of improvement;
- A system of preventive and corrective actions (CAPA); Triggered by the multitude of quality indicators and monitoring of trends to identify root causes;
- A change management system; Changes, whatever their origins (surveillance, CAPA, improvements ..) is the driving force of innovation. The establishment of Quality by Design is a factor in regulatory flexibility with respect to changes;
- A management review of process performance and product quality; Monitoring and support processes are tools to assess the adequacy of the system and its effectiveness.
These elements are used to manage the PQS and are sources of continuous improvement of the product and services.