Posted on: 27th November 2017
More than 50 per cent of biopharma products on the market now have Continued Process Verification (CPV) plans in place. Thanks to the CPV white paper, which can be found on the BPOG website here, the implementation of CPV now happens 30 per cent faster than before the paper was published. Moreover, this has decreased investigation times by up to 20 per cent meaning a real fiscal saving for member companies.
The CPV&I workstream have now published a comprehensive guide to the implementation of across a portfolio of legacy products. Legacy products constitute in excess of 70 per cent of the industry’s portfolio. This paper outlines:
-efficient and effective plans for legacy products and links to QA systems
-guidance on implementation across multiple sites
-guidance on discovery, disclosure and regulatory reporting.
The team will also publish a paper on the Validation of Informatics for CPV soon.
Over its four-year history, the team has generated an extensive body of knowledge. Feedback suggests this has been beneficial to the BPOG membership, with close to 1000 downloads of the original CPV paper.
The BPOG CPV&I activity transitioned to a Community of Practice this year. This transition has been highly successful, with three sub-teams actively working on: CPV Reporting Linked to APQRs, Multi-Variate Data Analysis for CPV, and the CPV at the License Holder / CMO Interface.
To read the paper in full click here and for further information contact email@example.com