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2023 Aseptic Conference

SES102a - Continuous Process Verification - A VPHP Case Study

‐ Mar 6, 2023 12:00pm

Do you know if your equipment and processes are in a state of control all year long? Our equipment and processes govern our products' quality; therefore, we regularly perform requalifications or revalidations. However, with this approach, we only see a snapshot of the state of control (maybe once a year or after two to five years) as this approach does not provide us with real-time data. Furthermore, these activities are time-consuming and lead to downtimes of several weeks. This approach also does not allow us to detect trends or problems within our processes or equipment before it may be too late, and then we have to question our products' quality.

We believe that by moving towards "Continuous Process Verification (CPV)," we can avoid the aforementioned constraints. Regulatory bodies have already defined the requirements of such an approach, e.g., in the ICH Q8 and the EMA GMP Annex 15. Let us look into the advantages of CPV by sharing our approach within the process of VPHP decontamination. We believe CPV will allow us to move away from the time-based requalifications and revalidations by ensuring a continuous state of control.


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