This project provided the client with a compliant, scalable CPV model that strengthened process control and enabled earlier detection of variability—setting a benchmark for future validation activities
About this Case Study
In this case study, we explore how Rephine supported a pharmaceutical manufacturing site facing internal resource constraints and lacking the expertise to initiate a Continued Process Verification (CPV) programme for one of its most critical processes.
Rephine’s consultants designed a tailored CPV policy aligned with GMP guidelines and regulatory expectations. The solution enabled the site to:
- Define key process parameters (CPPs) and critical quality attributes (CQAs)
- Establish appropriate control limits and statistical tools
- Evaluate performance using capability indices (Cp, Cpk)
- Prepare a regulator-ready CPV report
Over a six-month period, Rephine helped the client move from uncertainty to full implementation—delivering not just compliance, but enhanced decision-making and a scalable model for future products.
Download the full case study now to see how we translated CPV theory into measurable operational gains.
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