Manufacturing and Bioprocessing – Chemical
2019 PharmSci 360
The emerging nature of Continuous Manufacturing, combined with the limited experience in validating these processes across industry lead to a general gap in knowledge. For Continuous Manufacturing processes the role of the Pharmaceutical Development Scientist in understanding and contributing to Process Validation activities is arguably more important relative to batch processes. As a result the Pharmaceutical Development Scientist needs to be conversant in the overall process validation approach. Considering the current rate of change for Continuous Manufacturing and Process Validation in their own right, the knowledge gap is magnified.
This presentation will cover 3 main areas: 1) A case study for the Process Validation of a Continuously Manufactured solid oral dosage form using the traditional 3-stage Process Validation lifecycle as a baseline, 2) A review of efforts currently underway to optimize the Process Validation lifecycle model to enable more effective and efficient application to Continuous Manufacturing processes, and 3) Future perspectives on the implementation of Continuous Process Verification (ICH Q8).