Continuous Process Verification (CPV)

Need for this
Continuous Process Verification (CPV)

In pharmaceutical manufacturing, product quality and consistency are critical. Traditional process validation methods are limited by static data and batch-based validations. Regulatory bodies such as the FDA and EMA now emphasize ongoing assurance of process performance through Continuous Process Verification (CPV), a requirement of the Process Validation lifecycle. 

Challenges without Continuous Process Verification: 

Infrequent analysis of process data
Delayed detection of process drifts or deviations
Manual data collection leading to human error
Regulatory non-compliance risks

Hence, there is a need for a robust, automated, and data-integrated CPV approach to continuously monitor Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs). 

Benefits of Continuous Process Verification (CPV)

Implementing CPV provides the following tangible benefits: 

Real-Time Process Monitoring

Enables proactive decision-making using live data.

Early Detection of Deviations

Prevents out-of-specification (OOS) incidents.

Reduced Manual Work

Automated data ingestion reduces errors and time spent.

Regulatory Readiness

Ensures continuous compliance with FDA 21 CFR Part 11, EU GMP Annex 15, and ICH Q8-Q10.

Data-Driven Improvements

Continuous insights into process behavior help optimize performance.
Process Diagram
1

Identify Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs)

Predefine crucial parameters having direct impact on product quality, establish control limits, alert thresholds, and statistical rules.
2

Continuous Data Collection and Analysis

Integration with various data sources such as ERP/MES, Equipment, Instruments, Software, PLC, SCADA, HMI for real-time and batch-wise data on parameters such as temperature, pressure, pH, blending time, assay, moisture content and many more.
3

Data Processing & Validation

Extracted data interpretation through built in connectors and Verification against predefined upper and lower limits.
4

Single click CPV

Graphical representation of data into SPC Charts, trend plots, along with process control dashboards for real-time monitoring, continuous verification and single click report generation.
5

Ongoing Review and Adaptation

Regularly review the CPV and adapt as needed to reflect changes in the manufacturing process or regulatory requirements.
CPV with ProcessXE ®
Identification of CQAs and CPPs:
Define product-specific Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs)
Configure control limits, alert thresholds, and SPC rules in ProcessXE
Continuous Data Collection and Analysis:
Integration with MES/ERP, SCADA/PLC/HMI, LIMS, Instruments/Equipment to collect both real-time and historical data enabling comprehensive analysis of process trends and deviations
Data Processing & Validation:
Data processing through Built-in connectors for structured extraction and Validation against predefined upper/lower control limits to ensure data accuracy, contextualization, and compliance before analysis.
CPV Dashboards & Reporting:
SPC charts, control plots, trend analysis, and batch overlays along with Dynamic dashboards for equipment-wise, stage-wise, and parameter-wise insights enabling Single-click CPV report generation.
Alerts, Deviations & Ongoing Monitoring:
Automated alerts and triggers for OOS/OOT events, automated deviation logging and continuous monitoring updates for 360° visibility.
Results of Implementation

Improved Product Consistency and Quality by 35%

Enhanced Operational Efficiency by 40%

Improved Process Capability Index (Cpk/Ppk) by 20%

time

Reduced Batch Release Time by 15%