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.
As with all aspects of our life sciences industry, understanding how we can best meet the needs of patients with the timely delivery of life saving and sustaining products is of paramount concern. During the years since the global pandemic, the expectations and pressures on the pharmaceutical industry with respect to development, speed to market, quality and sustainability have increased...
At the 2024 ISPE Europe Annual Conference, held in Lisbon, Portugal, 16-18 April, Richard L. Friedman, MS, Deputy Director of the US Food and Drug Administration’s (US FDA) Office of Manufacturing Quality, in...
Insight from Austria’s Regulatory Authority Representative
At the 2024 ISPE Aseptic Conference, held March 12-13 in Vienna, Austria, Christina Meissner, a European Union Good Manufacturing Practice (GMP) inspector at the Austrian Agency for Health and Food Safety since 2013, and Chair of the PIC/S Drafting Group on Annex 2A and 2B, published in May 2021, offered a presentation titled...