The Pharmaceutical Quality System: The 21st Century Approach

The Quality System is the nervous system of the GMP-body. The ruling brain is the Quality Manual, whereas the procedures which develop it are the nerves that control this GMP-body. The Pharmaceutical Quality System (PQS), as proposed by ICH Q10, has a slightly wider scope than GMP, as includes pharmaceutical development too. In terms of responsibility the senior direction of the company is a key factor of the quality system because determines its policy and objectives. The PQS is composed of two enablers and four elements. Enablers facilitate the attainment of the PQS objectives. A couple of elements were already in place relatively long ago (change management and CAPA system), whereas the other two are newcomers and focus on control on processes and products and on the PQS itself. The different approaches to the Quality Manual and its contents are described and commented. As a modern quality system is based on continual improvement it is necessary to identify and analyze the processes in the manufacturing plant. Processes can be kept in state of control by monitoring of variables/indicators. The latter can be monitored either during the same process (on-line or off-line) or after it by evaluation of data. Thus, improvement means variable/indicator improvement. The performance of the quality system itself must be reviewed by the management in order to ensure that it remains appropriate. The practical organization of the system is developed in documents known as general procedures of the system. The contents of these procedures are commented and their interrelations are analyzed.

Keywords: CAPA system, change management, continual improvement, document management, general procedures, incident management, knowledge management, management review, PAT, performance indicator, personnel management, PQS, Process manual, process map, Quality manual, quality objectives, quality risk management, quality policy, quality review, variable monitoring.