Continued Process Verification (CPV): A guide to integrating continued process verification (CPV) and annual product review (APR)

Continued process verification (CPV) provides ongoing verification of the performance of a manufacturing process. The requirements of CPV are very similar to the requirements for evaluating the quality standards to determine the need for changes to manufacturing or control procedures as part of an annual product review (APR). While many companies have modeled their CPV reporting on APR reporting processes, they have not always fully integrated the two processes, leading to inefficiencies. Also, many companies are not yet taking advantage of the opportunity that a fully validated CPV informatics system provides to further streamline the reporting processes. This workstream draws on the experiences of more than 20 biopharmaceutical manufacturing companies in creating CPV reports and integrating them with their APR processes to propose an approach that significantly improves efficiency while still complying with regulations and achieving the business benefits of a robust CPV program

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DS CPV and APR June 2021.pdf
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  • Create Date 28th June 2021
  • DOI https://doi.org/10.46220/2021DS002
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