A recent focus by the US Food and Drug Administration (FDA) on process monitoring and verification has highlighted a need in the biopharmaceutical industry for better collection, categorization and analysis of manufacturing data. Manufacturers are increasingly being challenged to show their systems implement some form of continued process verification and demonstrate how their data systems can provide deeper insights into the process.. However, there are a wide variety of approaches to meet this requirement.
Continued Process Verification (CPV) is a business process and set of tools for improving manufacturing and product quality. It uses manufacturing data, coupled with a number of statistical signal detection algorithms to detect variations in the process that may impact product quality or process consistency. When used correctly, it allows a manufacturer to understand whether their production process is consistently delivering product with acceptable quality attributes in a repeatable and robust manner.