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

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

Jun 2021 | , , ,

This paper 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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Continued process verification (CPV) of legacy products in the biopharmaceutical industry

Continued process verification (CPV) of legacy products in the biopharmaceutical industry

Jun 2018 | , , ,

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.

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