Integrated Process Modeling-A Process Validation Life Cycle Companion.

ABSTRACT: During the regulatory requested process validation of pharmaceutical manufacturing processes, companies aim to identify, control, and continuously monitor process variation and its impact on critical quality attributes (CQAs) of the final product. It is difficult to directly connect the impact of single process parameters (PPs) to final product CQAs, especially in biopharmaceutical process development and production, where multiple unit operations are stacked together and interact with each other. Therefore, we want to present the application of Monte Carlo (MC) simulation using an integrated process model (IPM) that enables estimation of process capability even in early stages of process validation. Once the IPM is established, its capability in risk and criticality assessment is furtherm

SUBMITTER: Zahel T 

PROVIDER: S-EPMC5746753 | biostudies-literature | 2017 Oct

REPOSITORIES: biostudies-literature