ses102c - Shaping the Future of Manufacturing Quality in Pharma

Participants will better understand how a holistic consideration of its own quality system can support the system’s effectiveness and compliance. The combination of several perspectives such as PQS effectiveness, quality maturity, and further ones can reliably predict inspection outcomes. Attendees will learn how the assessment can be structured and what the most important system’s features are when it comes to predict inspection outcomes for sterile facilities.

The content is the St.Gallen works on the US FDA funded project “RiskSurve” which has just been extended to a second year. The project aims at creating a comprehensive site surveillance model consolidating data from different dimensions and embedded in their relevant context. Conclusions and results for sterile facilities, especially from the first year of research, are presented. The features and accuracy of sterile specific predictive models are illustrated and compared to the non-sterile ones. The analysis is conducted on data stemming from St.Gallen’s extensive Operational Excellence research. Plant specific data are enriched with external publicly available and regulatory compliance data. Metrics have been scientifically identified with several statistical tests and validated into the predictive model.