This 100 page guide and case study is a response to US Food and Drug Administration (FDA) 2011 process validation guidance on Stage 3, ‘Process Validation: General Principles and Practices’. It describes the approach commonly referred to as ‘Continued Process Verification’ (CPV). The paper provides guidance on what is CPV, why it is important, and how might it be implemented. It offers specific recommendations on the content of a CPV Plan, along with associated rationale. Produced through a large collaborative industry effort, these recommendations are modeled around a typical cell culture production process for making a fictitious monoclonal antibody product, described in the ‘A-Mab Case Study’.
The paper is a key foundational document which introduces important topics such as an approach to legacy products and the validation of IT systems and their design. These important topics are then addressed in the following documents available from BioPhorum
Continued process verification (CPV) provides ongoing verification of the performance of a manufacturing process and as such entails the processing of large amounts of data. This paper draws on the experiences of multiple biopharmaceutical manufacturing companies in validating the informatics components of their CPV programs. It sheds light on common issues and provides recommendations and best practices. Computer systems validation is relevant across the lifecycle of a CPV informatics solution. As such the papers scope includes the initial and ongoing activities and deliverables to determine that the solution meets its intended uses and other requirements, for example, data integrity and performance requirements.
This guide to the implementation of continued process verification (CPV) across a portfolio of legacy products complements the foundational document 'Continued process verification (CPV): An industry position paper with an example plan' published in 2014. The guide helps biomanufacturers understand how to build efficient and effective plans for legacy products and links to QA systems, provides guidance on implementations across multiple sites and advises on discovery, disclosure and regulatory reporting.