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.
Stability sampling and testing are key to ensuring that products maintain safety, identity, strength, purity, and quality throughout their claimed shelf life. It is also a regulatory requirement per ICH Q5. However, storing product samples in different environmental conditions, testing those samples for three to five years (or more) after initial manufacture, and properly analyzing and...
ISPE hosted more than 450 attendees in person and virtually for the 2024 ISPE Aseptic Conference in Vienna, Austria. Keynotes and education sessions provided a comprehensive overview of key topics and trends...
Biopharmaceutical facility design is a critical aspect of the industry. Overall cost pressures in the global health system, regional requirements to deploy manufacturing rather than centralize manufacturing in one location, technology enhancements in cell biology and format, flexibility to accommodate multi-product campaigns with different production schedules, and speed-to-market are among...