In 2014, the members of the BioPhorum Operations Group (BPOG) produced a 100-page continued process verification (CPV) case study, entitled “Continued Process Verification: An Industry Position Paper with Example Protocol” (BioPhorum Operations Group, 2014). This case study captures the thought processes involved in creating a CPV plan for a new product in response to the FDA’s guidance on the subject introduced in 2011 (U.S. Food and Drug Administration, 2011). In so doing, it provided the specific example of a plan developed for a new molecular antibody product based on the “A MAb Case Study” that preceded it (CASSS CMC Biotech Working Group, 2009).
This document, originally published in the May/ June 2016 issue of the PDA Journal, provides a Roadmap that draws on the content of the CPV case study to provide a step-by-step guide in a more accessible form, with reference to a process map of the product lifecycle. To read the PDA article in full, download here