CPV – Continued process verification case study

CPV – Continued process verification case study


The BioPhorum Continued Process Verification team has written a paper in response to US Food and Drug Administration (FDA) 2011 process validation guidance on Stage 3, drug substance manufacture. 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.  Sections were written by representatives across the BioPhorum and 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. Some of the complications of implementation are addressed, with recommended approaches, but the issue of information technology (IT) systems is not dealt with directly.  The case for IT systems, their design and introduction, is the subject of other collaborative efforts facilitated by BioPhorum and some of the results of that work may be published in the future.
The paper forms a basis for further engagement and deeper understanding of CPV across the industry, including with the regulatory agencies.  A number of sub-topics have been considered since the paper was written and these are summarized later in this summary.
Given the importance of CPV in both compliance and process improvement terms, the authors encourage readers to share this paper with their colleagues, and welcome any comments or questions arising which can be submitted via the following email address: cpv@biophorum.com

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