Continued Process Verification: Driving Consistent Quality In Manufacturing

Continued process verification (CPV) is a critical stage of process validation in pharmaceutical manufacturing, ensuring processes stay in a validated state throughout a product's lifecycle. Guided by FDA and EU GMP Annex 15 requirements, CPV involves routine monitoring and analysis of critical process parameters (CPPs), key process parameters (KPPs), and monitored parameters (MPs) to maintain product quality, strength, and purity. Manufacturers use statistical process control (SPC) to set and revise control limits, detect trends, and address deviations using corrective and preventive actions (CAPA).

CPV follows three stages: process design, process qualification, and ongoing CPV. While the first two stages conclude at fixed points, CPV is continuous, requiring real-time data collection and analysis. Tools like Bio4C ProcessPad™ automate parameter tracking, root cause evaluations, and quarterly process reporting, simplifying compliance.

The CPV process includes defining parameter classifications, setting validation ranges, establishing control limits, and implementing trend detection rules. Data management software integrates and analyzes inputs from diverse sources, streamlining calculations of process capability (Cpk) and performance (Ppk), as well as control charting. This automation minimizes errors and enhances traceability, enabling manufacturers to efficiently monitor trends and improve processes.

Comprehensive documentation, including in-process monitoring, process trends, and CAPA reports, supports compliance and drives informed decision-making. With CPV, pharmaceutical manufacturers can sustain control over production, promptly address variations, and ensure consistent product quality across facilities and batches. Effective CPV systems optimize both regulatory adherence and operational efficiency.