Continued process verification (CPV): A roadmap for the implementation of continued process verification

In 2014, the members of BioPhorum produced a 100-page continued process verification case study, entitled Continued process verification (CPV): An industry position paper with an example plan. This case study captures the thought processes involved in creating a continued process verification plan for a new product in response to the U.S. Food and Drug Administration’s guidance on the subject introduced in 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 in 2009. This document provides a roadmap that draws on the content of the continued process verification case study to provide a step-by-step guide in a more accessible form, with reference to a process map of the product life cycle. It could be used as a basis for continued process verification implementation in a number of different scenarios:

For a single product and process
For a single site
To assist in the sharing of data monitoring responsibilities among sites
To assist in establishing data monitoring agreements between a customer company and a contract manufacturing organization