Case Study Interprets Continuous Process Verification Guidance

BioPhorum Operations Group (BPOG) has published a resource to help the biopharmaceutical industry deliver a high quality, consistent approach to continued process verification (CPV). The resource, a case study developed in response to Stage 3 process verification guidance from the FDA, is designed to help companies develop their own CPV approach by providing best practices and guidance on how to implement and demonstrate effective process validation.

The 100-page case study, “Continued Process Verification: An Industry Position Paper with Example Plan,” was written by subject matter experts from major biotech manufacturers. The document describes the thought processes behind the creation of a CPV plan.  Containing a model plan based on a generic monoclonal antibody (mAb) production process, the case study makes it clear how critical process parameters are identified, analyzed, and reported for every step in the process.