Continuous Process Verification

In pharmaceutical process and product development, design and qualification stages are succeeded by Continuous Process Verification (CPV).  This provides ongoing assurance that the product attributes remain within compliance for regulatory bodies. PharmaMV provides a comprehensive set of CPV tools which facilitate the integration and interfacing to your process and production environment in order to:

  • Report real-time results and soft-sensor data for critical quality attributes, CQA, prediction
  • Confirm that the process remains in a state of control during routine production
  • Comply with the FDA process validation

The CPV solution provides tools for the following requirements from FDA and EMA (ICH Q10) guidelines:

  • Verification of CPPs and CQAs when process is under normal state of control
  • Capabilities to detect when product acceptance criteria are met, including start-up and shutdown detection
  • Capability of verifying the system can reach and maintain intended process conditions over entire campaign
  • Capability of detecting excursions from target CPP and CQA values
  • Determining the impact of changes in production rate or equipment scaling on process dynamics
  • Capability to review and validate production data in quantitative/statistical analysis, including scrutiny of intra-batch and inter-batch data

*Continuous Manufacturing of Pharmaceuticals ISBN:9781119001324

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