Process validation studies are performed to support and demonstrate process robustness and understanding. The study results are also used to inform proper process controls to ensure consistent and robust manufacturing production. Although most processes are optimized to meet program-specific needs, some process step conditions have been consistently implemented across multiple programs and demonstrated similar process performance and effects. This extensive history and experience may provide pertinent information to enable science- and risk-based assessment in a process validation strategy. Through effective knowledge management and application of big data concepts, relevant historical validation knowledge can be further structured to compare overall trends, to inform and support associated risk scores for future process validation studies. A case study will be included that utilized prior validation knowledge to support and streamline process knowledge and validation strategy.

Application of big data to inform prior knowledge and facilitate process validation risk assessment

255th National Meeting (2018)

The official archive and repository for all ACS Meetings & Expositions abstracts and select posters or presentations.