Stability
Data Capture: Formulations of Intermediate, Drug Substance, and Final Drug
Product
Testing for stability and trending for
shelf life prediction is an important activity of engineers and scientists
involved in pharmaceutical or biologics drug development and manufacturing. With
the addition of a stability module within ProcessPadTM platform, scientists can
now perform this important aspect of process data management and analysis
without the need of exiting (or exporting the data) to an external system. Within
ProcessPad’s existing process sample test data management capability, we have
extended the capability of the software to capture and trend drug stability
data. We have made minimal changes to our existing test/assay data capture format
to ensure no additional training for lab and QA personnel entering, verifying,
and approving data.
The stability management console supports
specification limits management for each marketing region and tracks both
quantitative and qualitative specifications. Users can flag protocol
events/addendums or method changes for better correlation of data and quick
compilation of protocol data, events, or addendums throughout the entire
life-cycle of the protocol execution.
Shelf-life Prediction: ProcessPadTM
advanced statistical engine
ProcessPadTM platform now comes embedded with an advanced
statistics engine for predicting shelf-life for long term storage condition. All
the shelf-life prediction models designed for poolability of batches conforms
to statistical approaches mentioned in ICH-Q1E (Appendix B2.2).
Founded in 2010, Simplyfeye Softwares Private Ltd.
provides data analytic products and solutions to life science processing
companies. Its ProcessPadTM software enables these organizations to
maximize the value of their quality metric, process, QC and manufacturing data
throughout the product lifecycle. Simplyfeye is partnered with The WindshireGroup, LLC for marketing and servicing ProcessPadTM in the Americas.
ProcessPadTM uses a browser interface to
provide easy on-demand access, across functions and with suppliers, to data for
aggregation, management, visualization, and analysis. Organizations benefit
from more efficient use of human resources; process improvements and higher
manufacturing yields; more robust investigations and troubleshooting; higher
product quality; and better regulatory compliance.
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