- Process performance and product quality monitoring system
- Corrective action and preventive action (CAPA) system
- Change management system
- Management review of process performance and product quality
Today’s topic is related to “Elements of Pharmaceutical Quality System”
The intent of Pharmaceutical Quality System is to enhance the following four elements and promote the lifecycle approach to product quality.
These elements should be applied in a manner that is appropriate and proportionate to each of the product lifecycle stages, recognizing the differences among the stages and the different goals of each stage. Throughout the product lifecycle, companies are encouraged to evaluate opportunities for innovative approaches to improve product quality