Continued process verification (CPV): An industry position paper with an example plan
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). As one might expect, manufacturers in the biopharmaceutical sector all wish to respond to this guidance appropriately. A group of 20+ companies felt it would be valuable to work on this topic together, using the facilitation services of BioPhorum. This paper is one of the results of the collaborative effort. It is written as a consensus view of an acceptable CPV program, but it does not fully represent the internal policies of the contributing companies. It is a basis upon which to build and share knowledge further across the industry. The authors believe this is one of the first comprehensive papers on this topic.
The paper seeks to provide practical developments on the themes: what is CPV, why is it important, and how might it be implemented. It offers some specific recommendations on the content of a CPV Plan, along with associated rationale. These recommendations are based on a typical cell culture production process for making a fictitious monoclonal antibody product, described in the ‘A-Mab Case Study’. Consequently, not all of the details contained in this paper are going to apply directly to actual products or processes. The authors recognize that the A-Mab Case Study represents only one industry archetype, and that there are a number of others that are important. However, the concepts and principles upon which the content of this paper was derived should help with CPV implementation for a real product.
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) and the validation of informatics systems
Continued process verification (CPV) of legacy products in the biopharmaceutical industry
Continued process verification (CPV) signal responses in biopharma
Continued process verification (CPV): A roadmap for the implementation of continued process verification
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