Continued Process Verification (CPV), the 3rd Stage of the FDA process validation guidelines, represents the Ship of Theseus in bioprocessing:
Continued Process Verification can take a number of forms, but at its core, it is a study plan with a list of parameters and attributes that must be regularly controlled and observed during the lifecycle of the GMP bioprocess. Review at regular intervals is critical to ensure that the changes are not having an impact on present results.
The primary reasons for creating a Continued Process Verification plan are not only to achieve compliance with regulatory authorities, but also to prevent batch discards, mitigate process vulnerabilities, and find continuous improvement possibilities. Various important considerations are also discussed, including which data may be included in a Continued Process Verification plan, with what frequency should the attributes be monitored, and what level of statistical sophistication is required.
Lastly, the importance of data integrity is discussed, wherein the transfer of many different data sources to a centralized single-source-of-truth is critical to ensure that the data analysis is robust and reveals the correct signals to investigate.
The integration of data science in biopharmaceutical manufacturing, emphasizing data quality, tech transfer efficiency, and process optimization, is the heart of this track. Led by industry experts, discussions explore leveraging digital twins, predictive analytics, and continuous improvement initiatives. Additionally, interactive roundtable discussions provide attendees with a dynamic forum...
The pharmaceutical sector stands at a crossroads of immense possibilities. We are witnessing an unprecedented surge in innovation, fueled by a remarkable partnership between industry and regulatory authorities. For example, there are initiatives fostered by the US Food and Drug Administration (US FDA) to promote innovation with programs such as CATT (CBER Advanced Technologies Team) and ETP...
Through the ISPE Foundation Professional Development Grant program, Silas Tamufor attended the 2023 ISPE Annual Meeting & Expo in October 2023. Tamufor is a PhD student and ISPE Boston Chapter member who began serving as the ISPE Boston Educational Programs Committee Chair in December 2023. He, along with 87 other students and recent graduates, attended the conference thanks to the...