CONTINUED PROCESS VERIFICATION – A CASE STUDY FROM BPOG
BPOG is a cross-industry collaboration with the aim of sharing operational best practices in the areas of drugs substance manufacturing, process development and fill finish. Established in 2008 the BPOG community has grown and matured, becoming a place where collaborations focus on the industry’s most critical topics, addressing key challenges of industry manufacturers. It now exerts strong influence upon the wider biotech community, regulators, standards agencies and the supply base.
The BPOG 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 BPOG 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.
To download your free copy of the paper, please click on the link below (you will be asked to complete a very short registration form so that we know who is interested in this topic.) You will be linked immediately to the CPV Paper - 'interactive' and 'print ready' versions.
CPV Paper --- www.biophorum.com