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.
Download the Case Study
View other our other resources and company news
Guide Medical Device Software Testing for MDR/IVDR Compliance | Rephine Guide
Case Study Implementing a Site-Wide CPV Strategy to Strengthen Process Control
Blog Continued Process Verification (CPV) in GMP Manufacturing
Medical Device The Artificial Intelligence Act (EU 2024/1689) Whitepaper: Key Obligations, Risks, and Compliance
Guide When Does Medical Software Qualify as a Medical Device? | MDR & IVDR Guide
Case Study Navigating DMF Registration in China with Rephine
Blog Breaking into the Chinese Pharmaceutical Market: How to Successfully File a DMF
CSV Understanding ICH E6 (R3): Good Clinical Practice and Computerised Systems Validation
Guide