By BioPhorum
Evaluating the health of biologics manufacturing processes has evolved since it began more than a decade ago. Current practice is described in the 2011 FDA guideline Process Validation: General Principles and Practices and in the 2012 European Medicines Agency (EMA) Guideline on Process Validation and is now commonly known as continued process verification (CPV).
The FDA and EMA guidance emphasized the importance of pharmaceutical manufacturers using CPV as an integral part of their process validation life cycle to provide ongoing assurance that the process is a tool for identifying opportunities for continuous improvement.
CPV requirements are similar to those for evaluating the quality standards that determine the need for changes to manufacturing or control procedures as part of the annual product review (APR) report. However, while many companies have modeled their CPV reporting on the APR reporting process, irrespective of good manufacturing practices (GMP), often they have not fully integrated the two processes, leading to inefficiencies. Also, many companies have not yet taken advantage of the opportunity that a fully validated CPV informatics system provides to further streamline the reporting processes. Current CPV practice varies among companies for various reasons, e.g., the level of process knowledge acquired before engaging in process validation activities and the use of automated vs. manual data acquisition.
