How to Implement Continued Process Verification (CPV) for Process Monitoring

“Pharmaceutical Companies should plan and execute a system for the monitoring of process performance and product quality to ensure a state of control is maintained. An effective monitoring system provides assurance of the continued capability of processes and controls to meet product quality and to identify areas for continual improvement” – ICH Q10 Guidance

“We recommend continued monitoring and sampling of process parameters and quality attributes at the level established during the process qualification stage until sufficient data are available to generate significant variability estimates…Process variability should be periodically assessed and monitoring adjusted accordingly” – FDA Process Validation Guidance 2011

Unsurprisingly. we detected an update in industry interest in CPV after the above guidance was released. This is a good thing, but it’s unfortunate that it takes regulatory pressure to move pharmaceutical companies towards best practices for capturing and managing manufacturing data that potato chip and soap manufacturers adopted many, many years ago. In the late nineteenth century, Guinness, the beer brewer, was the first company to adopt statistical process control (SPC) for an industrial process, yet engineers and scientists struggle to get their hands on process and manufacturing data at many pharmaceutical companies in the 21^st century. I often said earlier in my career my biggest problem was getting my hands on the data I needed. Once I had it, I was invariably able to solve the problem or improve the process.

A well done and detailed case study has been published by BPOG (Biophorum Operations Group) on how to implement CPV. Though this case study is very detailed, here below is summarized in a flow chart the steps involved in setting up CPV. This gives an idea of what procedures, tools and efforts needed to rapidly set up a CPV program at your organization.