Continued and Collective analyses of enterprise wide processes and verifying its effectiveness against critical process parameters.
Process XE Continuous Process Verification (CPV) provides ability to analyze critical process parameters (CPP) to ensure that those are in acceptable and permissible range. Stage 3 of the process validation guidance calls for continued process validation.
US FDA process validation guidance suggests the need to detect and understand the variation and impact of that variation on product quality. The key purpose is to ensure that processes are in a constant state of control, and so is final product quality. Effective process verification will help in identifying inconsistencies in the process.
Processes in pharmaceuticals are always validated, but it is subject to changes in equipment conditions, suppliers of raw materials, etc. CPV is performed to prove that process remains in validated state.
For pharmaceuticals manufacturers, CPV helps to mitigate the risks of batch discards and find continuous improvements. It is important to identify which attributes and data needed to be monitored, at what frequency and level of statistical analyses needed on those.
The system capabilities include:
- Defining CPP (Critical Process Parameters) and CQA (Critical Quality Attributes) with their expected results with allowable variations
- Capturing values directly from machines, inputs or allows import of data generated from other tools and solutions
- Available interface with other ERP, MES, LIMS and/or DAS
- Easy to use statistical tool box for analyses
- Analyses can be based on products, instruments, batch data, etc.
- Trending of batch data on control chart to understand process variability
- Ability to export process data, charts to Excel, PDF which can be merged with other reports like periodic PQR (Product Quality Review)