From 9th to the 10th of April 2018, the 2018 Continued and On-Going Process Verification (CPV) Conference will take place in Berlin, Germany. Exputec is pleased to announce a presentation by our Head of Data Science, Christopher Taylor on “Understanding Variation though Integrated Process Modelling during Development and Routine Manufacturing”
In order to consistently manufacture pharmaceutical products that meet all quality requirements, a deep understanding of process variation models must be established from development on through to routine manufacturing. An approach to process characterization called Integrated Process Modelling (IPM) is depicted within the inCyght Software, that emphasizes quantifying variation through several layers of modelling (i.e. FMEA, CQA clearance models, loading models, DoE transfer functions) and concatenating them within a Monte Carlo simulation. This simulated distributed will assist to establish correct Quality ranges and also may be trained with continuous routine manufacturing data in the CPV program. Within this context, a multivariate CPV tool is depicted, leveraging robust statistics (here, Robust PCA) to allow for simple model building and interpretation by quality and operations, allowing a continuous monitoring of CPPs and CQAs during and across batches. All data may be continuously fed back into the integrated process model for further prediction refinement.
We will additionally have a stand at the conference and would love to meet you and demonstrate inCyght software!